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Clinical Trial Results:
A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stage IIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (METΔex14).

Summary
EudraCT number	2020-001578-31
Trial protocol	HU NL DE PT FR LT BE IT BG
Global end of trial date	06 Nov 2023

Results information
Results version number	v2(current)
This version publication date	23 Feb 2025
First version publication date	06 Oct 2024
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CINC280A2301

ISRCTN number

US NCT number

NCT04427072

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

Novartis Campus, Basel, Switzerland,

Public contact

Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, Novartis.email@novartis.com

Scientific contact

Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, Novartis.email@novartis.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Nov 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Nov 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of this trial was to compare the efficacy of capmatinib versus docetaxel. Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

25 Sep 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 1

Country: Number of subjects enrolled

Brazil: 1

Country: Number of subjects enrolled

France: 2

Country: Number of subjects enrolled

Germany: 3

Country: Number of subjects enrolled

India: 3

Country: Number of subjects enrolled

Italy: 3

Country: Number of subjects enrolled

Korea, Republic of: 1

Country: Number of subjects enrolled

Netherlands: 1

Country: Number of subjects enrolled

Portugal: 1

Country: Number of subjects enrolled

Spain: 6

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

All inclusion and exclusion criteria were checked at screening.

Period 1 title

Randomized Treatment Phase (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Capmatinib

Arm description

400 mg, capmatinib tablets, administered orally twice daily

Arm type

Experimental

Investigational medicinal product name

Capmatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

400 mg, capmatinib tablets, administered orally twice daily

Docetaxel

Arm description

Docetaxel 75 mg/m^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle

Arm type

Active comparator

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Docetaxel 75 mg/m^2 by intravenous infusion every 21 days

Number of subjects in period 1	Capmatinib	Docetaxel
Started	15	7
Treated	15	6
Completed	0	0
Not completed	15	7
Adverse event, serious fatal	-	1
Adverse event, non-fatal	3	1
Study terminated by sponsor	3	-
Progressive disease	9	4
Not treated (participant decision)	-	1

Baseline characteristics

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Reporting group title

Capmatinib

Reporting group description

400 mg, capmatinib tablets, administered orally twice daily

Reporting group title

Docetaxel

Reporting group description

Docetaxel 75 mg/m^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle

Reporting group values	Capmatinib	Docetaxel	Total
Number of subjects	15	7	22
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	5	2	7
From 65-84 years	10	5	15
85 years and over	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	67.6 ( 9.26 )	65.1 ( 4.98 )	-
Sex: Female, Male
Units: participants
Female	8	3	11
Male	7	4	11
Race/Ethnicity, Customized
Units: Subjects
White	11	6	17
Asian	3	0	3
Unknown	1	1	2

End points

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Reporting group title

Capmatinib

Reporting group description

400 mg, capmatinib tablets, administered orally twice daily

Reporting group title

Docetaxel

Reporting group description

Docetaxel 75 mg/m^2 solution administered by intravenous infusion on Day 1 of every 21-day cycle

Primary: Progression-free Survival (PFS) per Blinded Independent Review Committee (BIRC) Using RECIST v1.1

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End point title

Progression-free Survival (PFS) per Blinded Independent Review Committee (BIRC) Using RECIST v1.1 ^[1]

End point description

Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by BIRC according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date.

End point type

Primary

End point timeframe

From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are reported.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: months
median (confidence interval 95%)	6.1 (1.61 to 13.77)	4.1 (1.22 to 999)

No statistical analyses for this end point

Secondary: Overall Response Rate (ORR) per RECIST 1.1 by Investigator

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End point title

Overall Response Rate (ORR) per RECIST 1.1 by Investigator

End point description

Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

End point type

Secondary

End point timeframe

Up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: percentage of participants
number (confidence interval 95%)	46.7 (21.27 to 73.41)	14.3 (0.36 to 57.87)

No statistical analyses for this end point

Secondary: Time to Response (TTR) per RECIST 1.1 by BIRC

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End point title

Time to Response (TTR) per RECIST 1.1 by BIRC

End point description

Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

End point type

Secondary

End point timeframe

From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	8	0 ^[2]
Units: months
median (full range (min-max))	3.2 (1.2 to 15.3)	( to )

Notes
[2] - Data are reported for responders only.

No statistical analyses for this end point

Secondary: Overall Response (ORR) per RECIST 1.1 by BIRC

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End point title

Overall Response (ORR) per RECIST 1.1 by BIRC

End point description

Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

End point type

Secondary

End point timeframe

Up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: percentage of participants
number (confidence interval 95%)	53.3 (26.59 to 78.73)	0 (0 to 40.96)

No statistical analyses for this end point

Secondary: Time to Response (TTR) per RECIST 1.1 by Investigator

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End point title

Time to Response (TTR) per RECIST 1.1 by Investigator

End point description

Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

End point type

Secondary

End point timeframe

From date of randomization to first documented response of either CR or PR, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	7	1
Units: months
median (full range (min-max))	1.3 (1.2 to 15.5)	2.8 (2.8 to 2.8)

No statistical analyses for this end point

Secondary: Duration of Response (DOR) per RECIST 1.1 by BIRC

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End point title

Duration of Response (DOR) per RECIST 1.1 by BIRC

End point description

Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

End point type

Secondary

End point timeframe

From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	8	0 ^[3]
Units: months
median (confidence interval 95%)	12.6 (2.92 to 999)	( to )

Notes
[3] - Data are reported for responders only.

No statistical analyses for this end point

Secondary: Duration of Response (DOR) per RECIST 1.1 by Investigator

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End point title

Duration of Response (DOR) per RECIST 1.1 by Investigator

End point description

Duration of response was defined as the time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

End point type

Secondary

End point timeframe

From first documented response to first documented progression or death due to any cause, whichever came first, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	7	1
Units: months
median (confidence interval 95%)	9.9 (2.92 to 999)	3.1 (0.999 to 999)

No statistical analyses for this end point

Secondary: Disease Control Rate (DCR) per RECIST 1.1 by BIRC

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End point title

Disease Control Rate (DCR) per RECIST 1.1 by BIRC

End point description

Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

End point type

Secondary

End point timeframe

Up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: percentage of participants
number (confidence interval 95%)	73.3 (44.90 to 92.21)	57.1 (18.41 to 90.10)

No statistical analyses for this end point

Secondary: Disease Control Rate (DCR) per RECIST 1.1 by Investigator

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End point title

Disease Control Rate (DCR) per RECIST 1.1 by Investigator

End point description

Disease control rate was defined as the percentage of participants with a best overall response (BOR) of confirmed CR, PR and stable disease (SD) assessed by local review according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

End point type

Secondary

End point timeframe

Up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: percentage of participants
number (confidence interval 95%)	86.7 (59.54 to 98.34)	42.9 (9.90 to 81.59)

No statistical analyses for this end point

Secondary: Progression-free Survival (PFS) per Investigator Using RECIST v1.1

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End point title

Progression-free Survival (PFS) per Investigator Using RECIST v1.1

End point description

Progression-free survival was defined as the time from the date of randomization to the date of the first documented progressive disease (PD) as assessed by local review according to RECIST 1.1, or death due to any cause. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2.

End point type

Secondary

End point timeframe

From randomization to the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: months
median (confidence interval 95%)	6.1 (2.66 to 11.10)	3.6 (1.22 to 999)

No statistical analyses for this end point

Secondary: Overall Survival (OS)

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End point title

Overall Survival (OS)

End point description

OS was defined as the time from the date of randomization to the date of death due to any cause.

End point type

Secondary

End point timeframe

From randomization to death due to any cause, assessed up to approximately 36 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: months
median (confidence interval 95%)	12.5 (4.30 to 999)	13.6 (2.60 to 999)

No statistical analyses for this end point

Secondary: Overall Intracranial Response Rate (OIRR)

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End point title

Overall Intracranial Response Rate (OIRR)

End point description

Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose.

End point type

Secondary

End point timeframe

Up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	1	0 ^[4]
Units: Percentage of participants
number (confidence interval 95%)	0 (0.00 to 97.50)	( to )

Notes
[4] - Data are reported for responders only.

No statistical analyses for this end point

Secondary: Duration of Intracranial Response (DOIR)

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End point title

Duration of Intracranial Response (DOIR)

End point description

Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer.

End point type

Secondary

End point timeframe

From date of first documented intracranial response (CR or PR) to first documented intracranial progression, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	0 ^[5]	0 ^[6]
Units: months
median (confidence interval 95%)	( to )	( to )

Notes
[5] - DOIR could not be analyzed as there were no participants with intracranial response.
[6] - DOIR could not be analyzed as there were no participants with intracranial response.

No statistical analyses for this end point

Secondary: Time to Intracranial Response (TTIR)

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End point title

Time to Intracranial Response (TTIR)

End point description

Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed.

End point type

Secondary

End point timeframe

From date of randomization to first documented intracranial response of either CR or PR, assessed up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	0 ^[7]	0 ^[8]
Units: months
median (confidence interval 95%)	( to )	( to )

Notes
[7] - TTIR could not be analyzed as there were no participants with intracranial response.
[8] - TTIR could not be analyzed as there were no participants with intracranial response.

No statistical analyses for this end point

Secondary: Intracranial Disease Control Rate (IDCR)

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End point title

Intracranial Disease Control Rate (IDCR)

End point description

Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC. Criteria for CR: Disappearance of all central nervous system (CNS) target and non-target lesions sustained for at least 4 weeks, with no new lesions, and no use of corticosteroids. PR: ≥30% decrease in the sublaterodorsal tegmental nucleus (SLD) of CNS target lesions or no new lesions or and stable to decreased corticosteroid dose.

End point type

Secondary

End point timeframe

Up to approximately 21 months

End point values	Capmatinib	Docetaxel
Number of subjects analysed	1	0 ^[9]
Units: percentage of participants
number (confidence interval 95%)	100 (2.50 to 100)	( to )

Notes
[9] - Not applicable to this reporting group.

No statistical analyses for this end point

Secondary: Plasma Capmatinib Concentration

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End point title

Plasma Capmatinib Concentration ^[10]

End point description

Plasma concentrations of capmatinib. Blood samples were collected at indicated time points for pharmacokinetic analysis.

End point type

Secondary

End point timeframe

Cycle (C) 1 Day (D) 15 pre-dose, 1 and 4 hours post-dose, C3 D1 pre-dose. Each cycle duration was 21 days.

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was only applicable for participants who received capmatinib.

End point values	Capmatinib
Number of subjects analysed	14
Units: μg/mL
geometric mean (geometric coefficient of variation)
Cycle 1, Day 15, 0 hour n=12	496 ( 97.3 )
Cycle 1, Day 15, 1 hour n=10	1330 ( 214.6 )
Cycle 1, Day 15, 4 hours n=11	2680 ( 131.1 )
Cycle 3, Day 1, 0 hour n=10	243 ( 140.6 )

No statistical analyses for this end point

Secondary: Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

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End point title

Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

End point description

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. CFB = change from baseline.

End point type

Secondary

End point timeframe

Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: score on a scale
arithmetic mean (standard deviation)
Global Health Status CFB at Cycle 3, Day 1 n=12,4	17.4 ( 18.96 )	4.2 ( 14.43 )
Global Health Status CFB at Cycle 5, Day n=8,3	14.6 ( 22.16 )	8.3 ( 14.43 )
Global Health Status CFB at Cycle 7, Day 1 n=8,1	15.6 ( 16.33 )	-8.3 ( 999 )
Global Health Status CFB at Cycle 9, Day 1 n=7,2	9.5 ( 16.96 )	0.0 ( 11.79 )
Global Health Status CFB at Cycle 11, Day 1 n=7,0	3.6 ( 15.85 )	999 ( 999 )
Global Health Status CFB at Cycle 13, Day 1 n=5,0	25.0 ( 10.21 )	999 ( 999 )
Global Health Status CFB at Cycle 15, Day 1 n=5,0	10.0 ( 10.87 )	999 ( 999 )
Global Health Status CFB at Cycle 17, Day 1 n=4,0	18.8 ( 10.49 )	999 ( 999 )
Global Health Status CFB at Cycle 19, Day 1 n=5,0	-1.7 ( 19.00 )	999 ( 999 )
Global Health Status CFB at Cycle 21, Day 1 n=4,0	0.0 ( 0.00 )	999 ( 999 )
Global Health Status CFB at Cycle 23, Day 1 n=2,0	-8.3 ( 11.79 )	999 ( 999 )
Global Health Status CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Global Health Status CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Global Health Status CFB at Cycle 29, Day 1 n=2,0	-29.2 ( 29.46 )	999 ( 999 )
Physical Functioning CFB at Cycle 3, Day 1 n=12,4	11.1 ( 24.01 )	-1.7 ( 6.38 )
Physical Functioning CFB at Cycle 5, Day 1 n=8,3	15.0 ( 21.89 )	-13.3 ( 23.09 )
Physical Functioning CFB at Cycle 7, Day 1 n=8,1	4.2 ( 26.41 )	0.0 ( 999 )
Physical Functioning CFB at Cycle 9, Day 1 n=7,2	7.6 ( 22.25 )	3.3 ( 14.14 )
Physical Functioning CFB at Cycle 11, Day 1 n=7,0	-1.9 ( 25.74 )	999 ( 999 )
Physical Functioning CFB at Cycle 13, Day 1 n=5,0	5.3 ( 25.99 )	999 ( 999 )
Physical Functioning CFB at Cycle 15, Day 1 n=5,0	-1.3 ( 15.92 )	999 ( 999 )
Physical Functioning CFB at Cycle 17, Day 1 n=4,0	-5.0 ( 13.74 )	999 ( 999 )
Physical Functioning CFB at Cycle 19, Day 1 n=5,0	-2.7 ( 32.52 )	999 ( 999 )
Physical Functioning CFB at Cycle 21, Day 1 n=4,0	5.0 ( 10.00 )	999 ( 999 )
Physical Functioning CFB at Cycle 23, Day 1 n=2,0	0.0 ( 9.43 )	999 ( 999 )
Physical Functioning CFB at Cycle 25, Day 1 n=2,0	13.3 ( 9.43 )	999 ( 999 )
Physical Functioning CFB at Cycle 27, Day 1 n=2,0	3.3 ( 4.71 )	999 ( 999 )
Physical Functioning CFB at Cycle 29, Day 1 n=2,0	0.0 ( 28.28 )	999 ( 999 )
Role Functioning CFB at Cycle 3, Day 1 n=12,4	20.8 ( 22.61 )	-4.2 ( 20.97 )
Role Functioning CFB at Cycle 5, Day 1 n=8,3	20.8 ( 29.21 )	-5.6 ( 25.46 )
Role Functioning CFB at Cycle 7, Day 1 n=8,1	18.8 ( 28.78 )	0.0 ( 999 )
Role Functioning CFB at Cycle 9, Day 1 n=7,2	14.3 ( 22.42 )	-8.3 ( 11.79 )
Role Functioning CFB at Cycle 11, Day 1 n=7,0	7.1 ( 26.97 )	999 ( 999 )
Role Functioning CFB at Cycle 13, Day 1 n=5,0	13.3 ( 21.73 )	999 ( 999 )
Role Functioning CFB at Cycle 15, Day 1 n=5,0	26.7 ( 19.00 )	999 ( 999 )
Role Functioning CFB at Cycle 17, Day 1 n=4,0	0.0 ( 13.61 )	999 ( 999 )
Role Functioning CFB at Cycle 19, Day 1 n=5,0	16.7 ( 50.00 )	999 ( 999 )
Role Functioning CFB at Cycle 21, Day 1 n=4,0	8.3 ( 16.67 )	999 ( 999 )
Role Functioning CFB at Cycle 23, Day 1 n=2,0	8.3 ( 11.79 )	999 ( 999 )
Role Functioning CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Role Functioning CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Role Functioning CFB at Cycle 29, Day 1 n=2,0	0.0 ( 47.14 )	999 ( 999 )
Emotional Functioning CFB at Cycle 3, Day 1 n=12,4	15.3 ( 32.14 )	2.1 ( 7.98 )
Emotional Functioning CFB at Cycle 5, Day 1 n=8,3	15.6 ( 31.32 )	11.1 ( 17.35 )
Emotional Functioning CFB at Cycle 7, Day 1 n=8,1	12.5 ( 34.21 )	-16.7 ( 999 )
Emotional Functioning CFB at Cycle 9, Day 1 n=7,2	8.3 ( 36.00 )	-8.3 ( 11.79 )
Emotional Functioning CFB at Cycle 11, Day 1 n=7,0	1.2 ( 23.29 )	999 ( 999 )
Emotional Functioning CFB at Cycle 13, Day 1 n=5,0	18.3 ( 25.28 )	999 ( 999 )
Emotional Functioning CFB at Cycle 15, Day 1 n=5,0	16.7 ( 19.54 )	999 ( 999 )
Emotional Functioning CFB at Cycle 17, Day 1 n=4,0	8.3 ( 11.79 )	999 ( 999 )
Emotional Functioning CFB at Cycle 19, Day 1 n=5,0	15.0 ( 21.57 )	999 ( 999 )
Emotional Functioning CFB at Cycle 21, Day 1 n=4,0	16.7 ( 15.21 )	999 ( 999 )
Emotional Functioning CFB at Cycle 23, Day 1 n=2,0	0.0 ( 11.79 )	999 ( 999 )
Emotional Functioning CFB at Cycle 25, Day 1 n=2,0	8.3 ( 47.14 )	999 ( 999 )
Emotional Functioning CFB at Cycle 27, Day 1 n=2,0	-8.3 ( 23.57 )	999 ( 999 )
Emotional Functioning CFB at Cycle 29, Day 1 n=2,0	8.3 ( 35.36 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 3, Day 1 n=12,4	12.5 ( 23.70 )	-8.3 ( 9.62 )
Cognitive Functioning CFB at Cycle 5, Day 1 n=8,3	6.3 ( 29.46 )	0.0 ( 16.67 )
Cognitive Functioning CFB at Cycle 7, Day 1 n=8,1	6.3 ( 33.26 )	16.7 ( 999 )
Cognitive Functioning CFB at Cycle 9, Day 1 n=7,2	7.1 ( 21.21 )	8.3 ( 11.79 )
Cognitive Functioning CFB at Cycle 11, Day 1 n=7,0	4.8 ( 23.00 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 13, Day 1 n=5,0	20.0 ( 18.26 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 15, Day 1 n=5,0	16.7 ( 16.67 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 17, Day 1 n=4,0	8.3 ( 21.52 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 19, Day 1 n=5,0	16.7 ( 28.87 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 21, Day 1 n=4,0	0.0 ( 13.61 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 23, Day 1 n=2,0	8.3 ( 35.36 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 25, Day 1 n=2,0	0.0 ( 47.14 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 27, Day 1 n=2,0	-8.3 ( 35.36 )	999 ( 999 )
Cognitive Functioning CFB at Cycle 29, Day 1 n=2,0	41.7 ( 11.79 )	999 ( 999 )
Social Functioning CFB at Cycle 3, Day 1 n=12,4	18.1 ( 37.91 )	-4.2 ( 25.00 )
Social Functioning CFB at Cycle 5, Day 1 n=8,3	12.5 ( 44.32 )	-22.2 ( 19.25 )
Social Functioning CFB at Cycle 7, Day 1 n=8,1	-2.1 ( 37.20 )	0.0 ( 999 )
Social Functioning CFB at Cycle 9, Day 1 n=7,2	0.0 ( 33.33 )	0.0 ( 47.14 )
Social Functioning CFB at Cycle 11, Day 1 n=7,0	-2.4 ( 35.26 )	999 ( 999 )
Social Functioning CFB at Cycle 13, Day 1 n=5,0	23.3 ( 25.28 )	999 ( 999 )
Social Functioning CFB at Cycle 15, Day 1 n=5,0	10.0 ( 25.28 )	999 ( 999 )
Social Functioning CFB at Cycle 17, Day 1 n=4,0	16.7 ( 23.57 )	999 ( 999 )
Social Functioning CFB at Cycle 19, Day 1 n=5,0	-13.3 ( 13.94 )	999 ( 999 )
Social Functioning CFB at Cycle 21, Day 1 n=4,0	-16.7 ( 13.61 )	999 ( 999 )
Social Functioning CFB at Cycle 23, Day 1 n=2,0	-8.3 ( 11.79 )	999 ( 999 )
Social Functioning CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Social Functioning CFB at Cycle 27, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Social Functioning CFB at Cycle 29, Day 1 n=2,0	-8.3 ( 11.79 )	999 ( 999 )
Fatigue CFB at Cycle 3, Day 1 n=12,4	-11.1 ( 31.43 )	-11.1 ( 9.07 )
Fatigue CFB at Cycle 5, Day 1 n=8,3	-12.5 ( 27.50 )	-14.8 ( 23.13 )
Fatigue CFB at Cycle 7, Day 1 n=8,1	-12.5 ( 29.36 )	-22.2 ( 999 )
Fatigue CFB at Cycle 9, Day 1 n=7,2	-12.7 ( 25.20 )	-11.1 ( 15.71 )
Fatigue CFB at Cycle 11, Day 1 n=7,0	-7.9 ( 27.75 )	999 ( 999 )
Fatigue CFB at Cycle 13, Day 1 n=5,0	-13.3 ( 27.67 )	999 ( 999 )
Fatigue CFB at Cycle 15, Day 1 n=5,0	-15.6 ( 16.85 )	999 ( 999 )
Fatigue CFB at Cycle 17, Day 1 n=4,0	-5.6 ( 14.34 )	999 ( 999 )
Fatigue CFB at Cycle 19, Day 1 n=5,0	-4.4 ( 26.76 )	999 ( 999 )
Fatigue CFB at Cycle 21, Day 1 n=4,0	-11.1 ( 15.71 )	999 ( 999 )
Fatigue CFB at Cycle 23, Day 1 n=2,0	0.0 ( 0.0 )	999 ( 999 )
Fatigue CFB at Cycle 25, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Fatigue CFB at Cycle 27, Day 1 n=2,0	5.6 ( 7.86 )	999 ( 999 )
Fatigue CFB at Cycle 29, Day 1 n=2,0	11.1 ( 31.43 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 3, Day 1 n=12,4	-1.4 ( 21.86 )	0.0 ( 0.00 )
Nausea and Vomiting CFB at Cycle 5, Day 1 n=8,3	-6.3 ( 26.63 )	11.1 ( 9.62 )
Nausea and Vomiting CFB at Cycle 7, Day 1 n=8,1	20.8 ( 39.59 )	0.0 ( 999 )
Nausea and Vomiting CFB at Cycle 9, Day 1 n=7,2	0.0 ( 23.57 )	0.0 ( 0.00 )
Nausea and Vomiting CFB at Cycle 11, Day 1 n=7,0	4.8 ( 28.41 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 13, Day 1 n=5,0	-3.3 ( 7.45 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 15, Day 1 n=5,0	0.0 ( 16.67 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 17, Day 1 n=4,0	8.3 ( 31.91 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 19, Day 1 n=5,0	20.0 ( 49.16 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 21, Day 1 n=4,0	20.8 ( 34.36 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 25, Day 1 n=2,0	8.3 ( 35.36 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 27, Day 1 n=2,0	16.7 ( 47.14 )	999 ( 999 )
Nausea and Vomiting CFB at Cycle 29, Day 1 n=2,0	8.3 ( 35.36 )	999 ( 999 )
Pain CFB at Cycle 3, Day 1 n=12,4	-4.2 ( 41.51 )	-25.0 ( 16.67 )
Pain CFB at Cycle 5, Day 1 n=8,3	-2.1 ( 31.42 )	5.6 ( 38.49 )
Pain CFB at Cycle 7, Day 1 n=8,1	-4.2 ( 42.49 )	-16.7 ( 999 )
Pain CFB at Cycle 9, Day 1 n=7,2	-4.8 ( 29.99 )	0.0 ( 0.00 )
Pain CFB at Cycle 11, Day 1 n=7,0	4.8 ( 50.66 )	999 ( 999 )
Pain CFB at Cycle 13, Day 1 n=5,0	0.0 ( 54.01 )	999 ( 999 )
Pain CFB at Cycle 15, Day 1 n=5,0	-6.7 ( 40.14 )	999 ( 999 )
Pain CFB at Cycle 17, Day 1 n=4,0	12.5 ( 77.43 )	999 ( 999 )
Pain CFB at Cycle 19, Day 1 n=5,0	6.7 ( 63.03 )	999 ( 999 )
Pain CFB at Cycle 21, Day 1 n=4,0	4.2 ( 43.83 )	999 ( 999 )
Pain CFB at Cycle 23, Day 1 n=2,0	25.0 ( 35.36 )	999 ( 999 )
Pain CFB at Cycle 25, Day 1 n=2,0	16.7 ( 70.71 )	999 ( 999 )
Pain CFB at Cycle 27, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Pain CFB at Cycle 29, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Dyspnea CFB at Cycle 3, Day 1 n=12,4	-13.9 ( 33.21 )	0.0 ( 0.00 )
Dyspnea CFB at Cycle 5, Day 1 n=8,3	-12.5 ( 30.54 )	11.1 ( 19.25 )
Dyspnea CFB at Cycle 7, Day 1 n=8,1	-4.2 ( 27.82 )	-33.3 ( 999 )
Dyspnea CFB at Cycle 9, Day 1 n=7,2	-4.8 ( 23.00 )	16.7 ( 23.57 )
Dyspnea CFB at Cycle 11, Day 1 n=7,0	14.3 ( 37.80 )	999 ( 999 )
Dyspnea CFB at Cycle 13, Day 1 n=5,0	6.7 ( 27.89 )	999 ( 999 )
Dyspnea CFB at Cycle 15, Day 1 n=5,0	20.0 ( 29.81 )	999 ( 999 )
Dyspnea CFB at Cycle 17, Day 1 n=4,0	8.3 ( 16.67 )	999 ( 999 )
Dyspnea CFB at Cycle 19, Day 1 n=5,0	13.3 ( 29.81 )	999 ( 999 )
Dyspnea CFB at Cycle 21, Day 1 n=	16.7 ( 43.03 )	999 ( 999 )
Dyspnea CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Dyspnea CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Dyspnea CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Dyspnea CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Insomnia CFB at Cycle 3, Day 1 n=12,4	-13.9 ( 26.43 )	8.3 ( 31.91 )
Insomnia CFB at Cycle 5, Day 1 n=8,3	0.0 ( 25.20 )	-22.2 ( 19.25 )
Insomnia CFB at Cycle 7, Day 1 n=8,1	-8.3 ( 34.50 )	-33.3 ( 999 )
Insomnia CFB at Cycle 9, Day 1 n=7,2	-4.8 ( 35.63 )	0.0 ( 0.00 )
Insomnia CFB at Cycle 11, Day 1 n=7,0	0.0 ( 38.49 )	999 ( 999 )
Insomnia CFB at Cycle 13, Day 1 n=5,0	0.0 ( 33.33 )	999 ( 999 )
Insomnia CFB at Cycle 15, Day 1 n=5,0	-13.3 ( 38.01 )	999 ( 999 )
Insomnia CFB at Cycle 17, Day 1 n=4,0	16.7 ( 43.03 )	999 ( 999 )
Insomnia CFB at Cycle 19, Day 1 n=5,0	-6.7 ( 49.44 )	999 ( 999 )
Insomnia CFB at Cycle 21, Day 1 n=4,0	0.0 ( 72.01 )	999 ( 999 )
Insomnia CFB at Cycle 23, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Insomnia CFB at Cycle 25, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Insomnia CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Insomnia CFB at Cycle 29, Day 1 n=2,0	16.7 ( 70.71 )	999 ( 999 )
Appetite Loss CFB at Cycle 3, Day 1 n=12,4	-16.7 ( 38.92 )	-8.3 ( 16.67 )
Appetite Loss CFB at Cycle 5, Day 1 n=8,3	4.2 ( 41.55 )	-11.1 ( 19.25 )
Appetite Loss CFB at Cycle 7, Day 1 n=8,1	-12.5 ( 24.80 )	0.0 ( 999 )
Appetite Loss CFB at Cycle 9, Day 1 n=7,2	-19.0 ( 32.53 )	0.0 ( 47.14 )
Appetite Loss CFB at Cycle 11, Day 1 n=7,0	-14.3 ( 42.41 )	999 ( 999 )
Appetite Loss CFB at Cycle 13, Day 1 n=5,0	-40.0 ( 36.51 )	999 ( 999 )
Appetite Loss CFB at Cycle 15, Day 1 n=5,0	-33.3 ( 47.14 )	999 ( 999 )
Appetite Loss CFB at Cycle 17, Day 1 n=4,0	-33.3 ( 47.14 )	999 ( 999 )
Appetite Loss CFB at Cycle 19, Day 1 n=5,0	-13.3 ( 73.03 )	999 ( 999 )
Appetite Loss CFB at Cycle 21, Day 1 n=4,0	-33.3 ( 47.14 )	999 ( 999 )
Appetite Loss CFB at Cycle 23, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Appetite Loss CFB at Cycle 25, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Appetite Loss CFB at Cycle 27, Day 1 n=2,0	-33.3 ( 0.00 )	999 ( 999 )
Appetite Loss CFB at Cycle 29, Day 1 n=2,0	-33.3 ( 0.00 )	999 ( 999 )
Constipation CFB at Cycle 3, Day 1 n=12,4	2.8 ( 38.82 )	-16.7 ( 19.25 )
Constipation CFB at Cycle 5, Day 1 n=8,3	-12.5 ( 35.36 )	0.0 ( 33.33 )
Constipation CFB at Cycle 7, Day 1 n=8,1	-4.2 ( 54.74 )	-33.3 ( 999 )
Constipation CFB at Cycle 9, Day 1 n=7,2	14.3 ( 26.23 )	-33.3 ( 0.00 )
Constipation CFB at Cycle 11, Day 1 n=7,0	-4.8 ( 44.84 )	999 ( 999 )
Constipation CFB at Cycle 13, Day 1 n=5,0	-20.0 ( 44.72 )	999 ( 999 )
Constipation CFB at Cycle 15, Day 1 n=5,0	-6.7 ( 54.77 )	999 ( 999 )
Constipation CFB at Cycle 17, Day 1 n=4,0	-16.7 ( 57.74 )	999 ( 999 )
Constipation CFB at Cycle 19, Day 1 n=5,0	-26.7 ( 43.46 )	999 ( 999 )
Constipation CFB at Cycle 21, Day 1 n=4,0	-16.7 ( 57.74 )	999 ( 999 )
Constipation CFB at Cycle 23, Day 1 n=2,0	33.3 ( 0.00 )	999 ( 999 )
Constipation CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Constipation CFB at Cycle 27, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Constipation CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Diarrhea CFB at Cycle 3, Day 1 n=12,4	0.0 ( 24.62 )	0.0 ( 0.00 )
Diarrhea CFB at Cycle 5, Day 1 n=8,3	-4.2 ( 11.79 )	-22.2 ( 38.49 )
Diarrhea CFB at Cycle 7, Day 1 n=8,1	0.0 ( 17.82 )	0.0 ( 999 )
Diarrhea CFB at Cycle 9, Day 1 n=7,2	14.3 ( 17.82 )	0.0 ( 0.00 )
Diarrhea CFB at Cycle 11, Day 1 n=7,0	4.8 ( 12.60 )	999 ( 999 )
Diarrhea CFB at Cycle 13, Day 1 n=5,0	0.0 ( 0.00 )	999 ( 999 )
Diarrhea CFB at Cycle 15, Day 1 n=5,0	6.7 ( 14.91 )	999 ( 999 )
Diarrhea CFB at Cycle 17, Day 1 n=4,0	16.7 ( 33.33 )	999 ( 999 )
Diarrhea CFB at Cycle 19, Day 1 n=5,0	13.3 ( 29.81 )	999 ( 999 )
Diarrhea CFB at Cycle 21, Day 1 n=4,0	8.3 ( 16.67 )	999 ( 999 )
Diarrhea CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Diarrhea CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Diarrhea CFB at Cycle 27, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Diarrhea CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Financial Difficulties CFB at C3, Day 1 n=12,4	-2.8 ( 26.43 )	0.0 ( 0.00 )
Finance Difficulties CFB at Cycle 5, Day 1 n=8,3	-8.3 ( 29.55 )	-11.1 ( 19.25 )
Finance Difficulties CFB at Cycle 7, Day 1 n=8,1	-4.2 ( 21.36 )	0.0 ( 999 )
Finance Difficulties CFB at Cycle 9, Day 1 n=7,2	0.0 ( 33.33 )	-33.3 ( 47.14 )
Finance Difficulties CFB at Cycle 11, Day 1 n=7,0	0.0 ( 19.25 )	999 ( 999 )
Finance Difficulties CFB at Cycle 13, Day 1 n=5,0	0.0 ( 23.57 )	999 ( 999 )
Finance Difficulties CFB at Cycle 15, Day 1 n=5,0	13.3 ( 18.26 )	999 ( 999 )
Finance Difficulties CFB at Cycle 17, Day 1 n=4,0	-8.3 ( 31.91 )	999 ( 999 )
Finance Difficulties CFB at Cycle 19, Day 1 n=5,0	13.3 ( 29.81 )	999 ( 999 )
Finance Difficulties CFB at Cycle 21, Day 1 n=4,0	25.0 ( 16.67 )	999 ( 999 )
Finance Difficulties CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Finance Difficulties CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Finance Difficulties CFB at Cycle 27, Day 1 n=2,0	33.3 ( 0.00 )	999 ( 999 )
Finance Difficulties CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

Top of page

End point title

Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

End point description

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included coughing, hemoptysis, dyspnea, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, and pain in other parts and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from “not at all” to “very much.” Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. CFB = change from baseline.

End point type

Secondary

End point timeframe

Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: score on a scale
arithmetic mean (standard deviation)
Coughing CFB at Cycle 3, Day 1 n=12,4	-19.4 ( 26.43 )	16.7 ( 19.25 )
Coughing CFB at Cycle 5, Day 1 n=8,3	-8.3 ( 23.57 )	11.1 ( 19.25 )
Coughing CFB at Cycle 7, Day 1 n=8,1	-20.8 ( 24.80 )	0.0 ( 999 )
Coughing CFB at Cycle 9, Day 1 n=7,2	-23.8 ( 25.20 )	0.0 ( 0.00 )
Coughing CFB at Cycle 11, Day 1 n=7,0	-9.5 ( 37.09 )	999 ( 999 )
Coughing CFB at Cycle 13, Day 1 n=5,0	-20.0 ( 29.81 )	999 ( 999 )
Coughing CFB at Cycle 15, Day 1 n=5,0	-6.7 ( 36.51 )	999 ( 999 )
Coughing CFB at Cycle 17, Day 1 n=4,0	0.0 ( 0.00 )	999 ( 999 )
Coughing CFB at Cycle 19, Day 1 n=5,0	-6.7 ( 14.91 )	999 ( 999 )
Coughing CFB at Cycle 21, Day 1 n=4,0	-8.3 ( 41.94 )	999 ( 999 )
Coughing CFB at Cycle 23, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Coughing CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Coughing CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Coughing CFB at Cycle 29, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Hemoptysis CFB at Cycle 3, Day 1 n=12,4	0.0 ( 0.00 )	8.3 ( 16.67 )
Hemoptysis CFB at Cycle 5, Day 1 n=8,3	0.0 ( 0.00 )	0.0 ( 0.00 )
Hemoptysis CFB at Cycle 7, Day 1 n=8,1	4.2 ( 11.79 )	0.0 ( 999 )
Hemoptysis CFB at Cycle 9, Day 1 n=7,2	0.0 ( 0.00 )	0.0 ( 0.00 )
Hemoptysis CFB at Cycle 11, Day 1 n=7,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 13, Day 1 n=5,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 15, Day 1 n=5,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 17, Day 1 n=4,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 19, Day 1 n=5,0	13.3 ( 29.81 )	999 ( 999 )
Hemoptysis CFB at Cycle 21, Day 1 n=4,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 23, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Hemoptysis CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Dyspnea CFB at Cycle 3, Day 1 n=12,4	-20.4 ( 21.10 )	0.0 ( 9.07 )
Dyspnea CFB at Cycle 5, Day 1 n=8,3	-18.1 ( 17.76 )	14.8 ( 16.97 )
Dyspnea CFB at Cycle 7, Day 1 n=8,1	-8.3 ( 29.55 )	11.1 ( 999 )
Dyspnea CFB at Cycle 9, Day 1 n=7,2	-14.3 ( 33.16 )	16.7 ( 23.57 )
Dyspnea CFB at Cycle 11, Day 1 n=7,0	-4.8 ( 32.62 )	999 ( 999 )
Dyspnea CFB at Cycle 13, Day 1 n=5,0	-13.3 ( 31.82 )	999 ( 999 )
Dyspnea CFB at Cycle 15, Day 1 n=5,0	-11.1 ( 27.22 )	999 ( 999 )
Dyspnea CFB at Cycle 17, Day 1 n=4,0	0.0 ( 9.07 )	999 ( 999 )
Dyspnea CFB at Cycle 19, Day 1 n=5,0	6.7 ( 30.02 )	999 ( 999 )
Dyspnea CFB at Cycle 21, Day 1 n=4,0	-2.8 ( 36.71 )	999 ( 999 )
Dyspnea CFB at Cycle 23, Day 1 n=2,0	-5.6 ( 7.86 )	999 ( 999 )
Dyspnea CFB at Cycle 25, Day 1 n=2,0	-5.6 ( 7.86 )	999 ( 999 )
Dyspnea CFB at Cycle 27, Day 1 n=2,0	-5.6 ( 7.86 )	999 ( 999 )
Dyspnea CFB at Cycle 29, Day 1 n=2,0	0.0 ( 15.71 )	999 ( 999 )
Sore Mouth CFB at Cycle 3, Day 1 n=12,4	-8.3 ( 25.13 )	0.0 ( 0.00 )
Sore Mouth CFB at Cycle 5, Day 1 n=8,3	-4.2 ( 11.79 )	0.0 ( 0.00 )
Sore Mouth CFB at Cycle 7, Day 1 n=8,1	-4.2 ( 27.82 )	0.0 ( 999 )
Sore Mouth CFB at Cycle 9, Day 1 n=7,2	9.5 ( 16.27 )	16.7 ( 23.57 )
Sore Mouth CFB at Cycle 11, Day 1 n=7,0	9.5 ( 16.27 )	999 ( 999 )
Sore Mouth CFB at Cycle 13, Day 1 n=5,0	13.3 ( 18.26 )	999 ( 999 )
Sore Mouth CFB at Cycle 15, Day 1 n=5,0	13.3 ( 29.81 )	999 ( 999 )
Sore Mouth CFB at Cycle 17, Day 1 n=4,0	16.7 ( 33.33 )	999 ( 999 )
Sore Mouth CFB at Cycle 19, Day 1 n=5,0	33.3 ( 33.33 )	999 ( 999 )
Sore Mouth CFB at Cycle 21, Day 1 n=4,0	8.3 ( 16.67 )	999 ( 999 )
Sore Mouth CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Sore Mouth CFB at Cycle 25, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Sore Mouth CFB at Cycle 27, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Sore Mouth CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Dysphagia CFB at Cycle 3, Day 1 n=12,4	0.0 ( 14.21 )	0.0 ( 0.00 )
Dysphagia CFB at Cycle 5, Day 1 n=8,3	8.3 ( 23.57 )	0.0 ( 0.00 )
Dysphagia CFB at Cycle 7, Day 1 n=8,1	12.5 ( 24.80 )	0.0 ( 999 )
Dysphagia CFB at Cycle 9, Day 1 n=7,2	4.8 ( 12.60 )	0.0 ( 0.00 )
Dysphagia CFB at Cycle 11, Day 1 n=7,0	9.5 ( 16.27 )	999 ( 999 )
Dysphagia CFB at Cycle 13, Day 1 n=5,0	6.7 ( 14.91 )	999 ( 999 )
Dysphagia CFB at Cycle 15, Day 1 n=5,0	13.3 ( 18.26 )	999 ( 999 )
Dysphagia CFB at Cycle 17, Day 1 n=4,0	25.0 ( 31.91 )	999 ( 999 )
Dysphagia CFB at Cycle 19, Day 1 n=5,0	20.0 ( 18.26 )	999 ( 999 )
Dysphagia CFB at Cycle 21, Day 1 n=4,0	25.0 ( 31.91 )	999 ( 999 )
Dysphagia CFB at Cycle 23, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Dysphagia CFB at Cycle 25, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Dysphagia CFB at Cycle 27, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Dysphagia CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 3, Day 1 n=12,4	13.9 ( 26.43 )	8.3 ( 31.91 )
Peripheral Neuropathy CFB at Cycle 5, Day 1 n=8,3	-4.2 ( 11.79 )	11.1 ( 38.49 )
Peripheral Neuropathy CFB at Cycle 7, Day 1 n=8,1	20.8 ( 17.25 )	-33.3 ( 999 )
Peripheral Neuropathy CFB at Cycle 9, Day 1 n=7,2	28.6 ( 23.00 )	-16.7 ( 23.57 )
Peripheral Neuropathy CFB at Cycle 11, Day 1 n=7,0	14.3 ( 17.82 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 13, Day 1 n=5,0	13.3 ( 18.26 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 15, Day 1 n=5,0	6.7 ( 14.91 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 17, Day 1 n=4,0	8.3 ( 16.67 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 19, Day 1 n=5,0	26.7 ( 43.46 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 21, Day 1 n=4,0	25.0 ( 31.91 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Peripheral Neuropathy CFB at Cycle 29, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Alopecia CFB at Cycle 3, Day 1 n=12,4	-8.3 ( 20.72 )	41.7 ( 41.94 )
Alopecia CFB at Cycle 5, Day 1 n=8,3	-16.7 ( 17.82 )	22.2 ( 19.25 )
Alopecia CFB at Cycle 7, Day 1 n=8,1	0.0 ( 25.20 )	-33.3 ( 999 )
Alopecia CFB at Cycle 9, Day 1 n=7,2	0.0 ( 19.25 )	0.0 ( 47.14 )
Alopecia CFB at Cycle 11, Day 1 n=7,0	9.5 ( 31.71 )	999 ( 999 )
Alopecia CFB at Cycle 13, Day 1 n=5,0	13.3 ( 29.81 )	999 ( 999 )
Alopecia CFB at Cycle 15, Day 1 n=5,0	0.0 ( 0.00 )	999 ( 999 )
Alopecia CFB at Cycle 17, Day 1 n=4,0	0.0 ( 0.00 )	999 ( 999 )
Alopecia CFB at Cycle 19, Day 1 n=5,0	20.0 ( 29.81 )	999 ( 999 )
Alopecia CFB at Cycle 21, Day 1 n=4,0	8.3 ( 16.67 )	999 ( 999 )
Alopecia CFB at Cycle 23, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Alopecia CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Alopecia CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Alopecia CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Pain in Chest CFB at Cycle 3, Day 1 n=12,4	-19.4 ( 22.29 )	-8.3 ( 41.94 )
Pain in Chest CFB at Cycle 5, Day 1 n=8,3	-8.3 ( 29.55 )	-11.1 ( 50.92 )
Pain in Chest CFB at Cycle 7, Day 1 n=8,1	-25.0 ( 15.43 )	-33.3 ( 999 )
Pain in Chest CFB at Cycle 9, Day 1 n=7,2	-23.8 ( 25.20 )	0.0 ( 47.14 )
Pain in Chest CFB at Cycle 11, Day 1 n=7,0	-4.8 ( 23.00 )	999 ( 999 )
Pain in Chest CFB at Cycle 13, Day 1 n=5,0	-13.3 ( 18.26 )	999 ( 999 )
Pain in Chest CFB at Cycle 15, Day 1 n=5,0	-13.3 ( 18.26 )	999 ( 999 )
Pain in Chest CFB at Cycle 17, Day 1 n=4,0	0.0 ( 27.22 )	999 ( 999 )
Pain in Chest CFB at Cycle 19, Day 1 n=5,0	-20.0 ( 18.26 )	999 ( 999 )
Pain in Chest CFB at Cycle 21, Day 1 n=4,0	0.0 ( 38.49 )	999 ( 999 )
Pain in Chest CFB at Cycle 23, Day 1 n=2,0	33.3 ( 47.14 )	999 ( 999 )
Pain in Chest CFB at Cycle 25, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Pain in Chest CFB at Cycle 27, Day 1 n=2,0	16.7 ( 23.57 )	999 ( 999 )
Pain in Chest CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 3, Day 1 n=12,4	-2.8 ( 30.01 )	-33.3 ( 38.49 )
Pain in Arm/Shoulder CFB at Cycle 5, Day 1 n=8,3	-8.3 ( 15.43 )	-22.2 ( 19.25 )
Pain in Arm/Shoulder CFB at Cycle 7, Day 1 n=8,1	-8.3 ( 34.50 )	-33.3 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 9, Day 1 n=7,2	-9.5 ( 37.09 )	-16.7 ( 70.71 )
Pain in Arm/Shoulder CFB at Cycle 11, Day 1 n=7,0	-9.5 ( 53.45 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 13, Day 1 n=5,0	-6.7 ( 36.51 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 15, Day 1 n=5,0	-26.7 ( 49.44 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 17, Day 1 n=4,0	-16.7 ( 57.74 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 19, Day 1 n=5,0	-6.7 ( 59.63 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 21, Day 1 n=4,0	-25.0 ( 56.93 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 23, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Pain in Arm/Shoulder CFB at Cycle 29, Day 1 n=2,0	-50.0 ( 70.71 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 3, Day 1 n=12,4	-8.3 ( 37.94 )	-8.3 ( 16.67 )
Pain in Other Parts CFB at Cycle 5, Day 1 n=8,3	-12.5 ( 17.25 )	0.0 ( 0.00 )
Pain in Other Parts CFB at Cycle 7, Day 1 n=8,1	-12.5 ( 35.36 )	33.3 ( 999 )
Pain in Other Parts CFB at Cycle 9, Day 1 n=7,2	-9.5 ( 16.27 )	16.7 ( 23.57 )
Pain in Other Parts CFB at Cycle 11, Day 1 n=7,0	4.8 ( 35.63 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 13, Day 1 n=5,0	-6.7 ( 14.91 )	999 ( 999 )
Pain in Other Parts at Cycle 15, Day 1 n=5,0	-13.3 ( 18.26 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 17, Day 1 n=4,0	16.7 ( 43.03 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 19, Day 1 n=5,0	20.0 ( 44.72 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 21, Day 1 n=	8.3 ( 16.67 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 23, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 27, Day 1 n=2,0	-16.7 ( 23.57 )	999 ( 999 )
Pain in Other Parts CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

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End point title

Change from Baseline in Score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

End point description

EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts– the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility. CFB = change from baseline.

End point type

Secondary

End point timeframe

Baseline, Cycle (C) 3, Day (D) 1 and then every 6 weeks up to approximately 21 months, end of treatment. Each cycle duration was 21 days.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: score on a scale
arithmetic mean (standard deviation)
Anxiety/Depression CFB at Cycle 3, Day 1 n=12,4	-0.6 ( 0.79 )	0.0 ( 0.82 )
Anxiety/Depression CFB at Cycle 5, Day 1 n=8,3	-0.3 ( 1.16 )	-0.7 ( 1.53 )
Anxiety/Depression CFB at Cycle 7, Day 1 n=8,1	-0.3 ( 1.39 )	-1.0 ( 999 )
Anxiety/Depression CFB at Cycle 9, Day 1 n=7,2	0.0 ( 1.41 )	0.0 ( 1.41 )
Anxiety/Depression CFB at Cycle 11, Day 1 n=7,0	0.4 ( 0.98 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 13, Day 1 n=5,0	-0.4 ( 1.14 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 15, Day 1 n=5,0	-0.2 ( 1.10 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 17, Day 1 n=4,0	0.5 ( 1.29 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 19, Day 1 n=5,0	-0.2 ( 0.84 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 21, Day 1 n=4,0	0.5 ( 1.73 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 23, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 25, Day 1 n=2,0	-0.5 ( 0.71 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Anxiety/Depression CFB at Cycle 29, Day 1 n=2,0	0.5 ( 2.12 )	999 ( 999 )
EQ VAS Score CFB at Cycle 3, Day 1 n=12,4	11.7 ( 17.99 )	10.3 ( 11.32 )
EQ VAS Score CFB at Cycle 5, Day 1 n=8,3	12.6 ( 12.47 )	10.3 ( 5.03 )
EQ VAS Score CFB at Cycle 7, Day 1 n=8,1	7.6 ( 15.34 )	-6.0 ( 999 )
EQ VAS Score CFB at Cycle 9, Day 1 n=7,2	6.7 ( 18.29 )	5.0 ( 8.49 )
EQ VAS Score CFB at Cycle 11, Day 1 n=7,0	-1.4 ( 14.36 )	999 ( 999 )
EQ VAS Score CFB at Cycle 13, Day 1 n=5,0	10.8 ( 21.23 )	999 ( 999 )
EQ VAS Score CFB at Cycle 15, Day 1 n=5,0	1.6 ( 10.88 )	999 ( 999 )
EQ VAS Score CFB at Cycle 17, Day 1 n=4,0	-4.5 ( 13.77 )	999 ( 999 )
EQ VAS Score CFB at Cycle 19, Day 1 n=5,0	2.0 ( 12.27 )	999 ( 999 )
EQ VAS Score CFB at Cycle 21, Day 1 n=4,0	-5.0 ( 10.80 )	999 ( 999 )
EQ VAS Score CFB at Cycle 23, Day 1 n=2,0	-7.5 ( 17.68 )	999 ( 999 )
EQ VAS Score CFB at Cycle 25, Day 1 n=2,0	-4.0 ( 26.87 )	999 ( 999 )
EQ VAS Score CFB at Cycle 27, Day 1 n=2,0	-17.0 ( 16.97 )	999 ( 999 )
EQ VAS Score CFB at Cycle 29, Day 1 n=2,0	-16.5 ( 9.19 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 3, Day 1 n=12,4	-0.3 ( 0.89 )	0.3 ( 0.96 )
Pain/Discomfort CFB at Cycle 5, Day 1 n=8,3	0.1 ( 0.99 )	0.0 ( 1.00 )
Pain/Discomfort CFB at Cycle 7, Day 1 n=8,1	0.4 ( 1.06 )	0.0 ( 999 )
Pain/Discomfort CFB at Cycle 9, Day 1 n=7,2	0.0 ( 0.82 )	1.0 ( 0.00 )
Pain/Discomfort CFB at Cycle 11, Day 1 n=7,0	0.1 ( 1.57 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 13, Day 1 n=5,0	0.6 ( 1.52 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 15, Day 1 n=5,0	0.0 ( 1.58 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 17, Day 1 n=4,0	0.8 ( 2.22 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 19, Day 1 n=5,0	-0.2 ( 1.48 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 21, Day 1 n=4,0	0.3 ( 1.71 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 23, Day 1 n=2,0	2.0 ( 0.00 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 25, Day 1 n=2,0	1.0 ( 1.41 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 27, Day 1 n=2,0	1.5 ( 0.71 )	999 ( 999 )
Pain/Discomfort CFB at Cycle 29, Day 1 n=2,0	0.5 ( 0.71 )	999 ( 999 )
Mobility CFB at Cycle 3, Day 1 n=12,4	-0.3 ( 0.75 )	-0.3 ( 0.96 )
Mobility CFB at Cycle 5, Day 1 n=8,3	-0.4 ( 0.92 )	0.7 ( 1.53 )
Mobility CFB at Cycle 7, Day 1 n=8,1	-0.1 ( 0.83 )	0.0 ( 999 )
Mobility CFB at Cycle 9, Day 1 n=7,2	-0.4 ( 0.98 )	1.0 ( 1.41 )
Mobility CFB at Cycle 11, Day 1 n=7,0	-0.1 ( 1.07 )	999 ( 999 )
Mobility CFB at Cycle 13, Day 1 n=5,0	-0.2 ( 0.84 )	999 ( 999 )
Mobility CFB at Cycle 15, Day 1 n=5,0	0.2 ( 0.45 )	999 ( 999 )
Mobility CFB at Cycle 17, Day 1 n=4,0	0.3 ( 0.96 )	999 ( 999 )
Mobility CFB at Cycle 19, Day 1 n=5,0	0.0 ( 1.00 )	999 ( 999 )
Mobility CFB at Cycle 21, Day 1 n=4,0	-0.3 ( 0.96 )	999 ( 999 )
Mobility CFB at Cycle 23, Day 1 n=2,0	0.5 ( 0.71 )	999 ( 999 )
Mobility CFB at Cycle 25, Day 1 n=2,0	0.5 ( 0.71 )	999 ( 999 )
Mobility CFB at Cycle 27, Day 1 n=2,0	1.0 ( 1.41 )	999 ( 999 )
Mobility CFB at Cycle 29, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Self-Care CFB at Cycle 3, Day 1 n=12,4	-0.2 ( 0.72 )	0.0 ( 0.00 )
Self-Care CFB at Cycle 5, Day 1 n=8,3	0.5 ( 0.76 )	0.0 ( 0.00 )
Self-Care CFB at Cycle 7, Day 1 n=8,1	0.0 ( 1.20 )	0.0 ( 999 )
Self-Care CFB at Cycle 9, Day 1 n=7,2	0.1 ( 1.35 )	0.0 ( 0.00 )
Self-Care CFB at Cycle 11, Day 1 n=7,0	0.1 ( 1.46 )	999 ( 999 )
Self-Care CFB at Cycle 13, Day 1 n=5,0	0.0 ( 1.22 )	999 ( 999 )
Self-Care CFB at Cycle 15, Day 1 n=5,0	0.0 ( 1.22 )	999 ( 999 )
Self-Care CFB at Cycle 17, Day 1 n=4,0	0.0 ( 1.63 )	999 ( 999 )
Self-Care CFB at Cycle 19, Day 1 n=5,0	0.0 ( 1.58 )	999 ( 999 )
Self-Care CFB at Cycle 21, Day 1 n=4,0	-0.3 ( 1.71 )	999 ( 999 )
Self-Care CFB at Cycle 23, Day 1 n=2,0	1.0 ( 1.41 )	999 ( 999 )
Self-Care CFB at Cycle 25, Day 1 n=2,0	1.0 ( 1.41 )	999 ( 999 )
Self-Care CFB at Cycle 27, Day 1 n=2,0	1.0 ( 1.41 )	999 ( 999 )
Self-Care CFB at Cycle 29, Day 1 n=2,0	-0.5 ( 0.71 )	999 ( 999 )
Usual Activities CFB at Cycle 3, Day 1 n=12,4	-0.7 ( 1.23 )	1.3 ( 0.50 )
Usual Activities CFB at Cycle 5, Day 1 n=8,3	-0.9 ( 1.55 )	0.7 ( 0.58 )
Usual Activities CFB at Cycle 7, Day 1 n=8,1	-0.8 ( 1.28 )	0.0 ( 999 )
Usual Activities CFB at Cycle 9, Day 1 n=7,2	-0.7 ( 0.95 )	1.5 ( 0.71 )
Usual Activities CFB at Cycle 11, Day 1 n=7,0	-0.7 ( 1.38 )	999 ( 999 )
Usual Activities CFB at Cycle 13, Day 1 n=5,0	-0.8 ( 0.84 )	999 ( 999 )
Usual Activities CFB at Cycle 15, Day 1 n=5,0	-0.4 ( 0.55 )	999 ( 999 )
Usual Activities CFB at Cycle 17, Day 1 n=4,0	-0.3 ( 0.50 )	999 ( 999 )
Usual Activities CFB at Cycle 19, Day 1 n=5,0	-0.4 ( 0.55 )	999 ( 999 )
Usual Activities CFB at Cycle 21, Day 1 n=4,0	-0.8 ( 0.96 )	999 ( 999 )
Usual Activities CFB at Cycle 23, Day 1 n=2,0	0.5 ( 0.71 )	999 ( 999 )
Usual Activities CFB at Cycle 25, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Usual Activities CFB at Cycle 27, Day 1 n=2,0	0.0 ( 0.00 )	999 ( 999 )
Usual Activities CFB at Cycle 29, Day 1 n=2,0	1.0 ( 1.41 )	999 ( 999 )

No statistical analyses for this end point

Secondary: Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

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End point title

Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

End point description

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The assessments here included chest pain, cough, and dyspnea and were based on their presence over the previous week. All but the pain domain were scored on a 4 point Likert scale ranging from “not at all” to “very much.” Pain was scored based on its presence, yes or no. Scores were averaged and transformed to 0 to 100. A higher score indicated a higher presence of symptoms. Time to symptom deterioration for chest pain, cough and dyspnea was assessed. Deterioration was assessed by the investigator.

End point type

Secondary

End point timeframe

Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: months
median (confidence interval 95%)
Coughing	13.9 (2.76 to 999)	2.9 (1.38 to 999)
Dyspnea	5.7 (2.76 to 999)	2.9 (1.38 to 999)
Pain in chest	11.1 (2.76 to 999)	2.9 (1.45 to 999)

No statistical analyses for this end point

Secondary: Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

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End point title

Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

End point description

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time to deterioration in QoL from EORTC-QLQ-C30 was assessed. Deterioration was assessed by the investigator.

End point type

Secondary

End point timeframe

Cycle (C) 1 Day (D) 1, C3 D1 and then every 6 weeks up to approximately 21 months, end of treatment and 6, 12, 18 weeks post treatment. Each cycle duration was 21 days.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	7
Units: months
median (confidence interval 95%)	999 (2.92 to 999)	999 (1.38 to 999)

No statistical analyses for this end point

Post-hoc: All Collected Deaths

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End point title

All Collected Deaths

End point description

On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.

End point type

Post-hoc

End point timeframe

On-treatment deaths: Up to approximately 117 weeks. Post-treatment survival follow-up deaths: Up to an additional 36 weeks.

End point values	Capmatinib	Docetaxel
Number of subjects analysed	15	6
Units: Participants
On-treatment deaths	2	0
Post-treatment deaths	7	5
All deaths	9	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 117 weeks.

Adverse event reporting additional description

Any sign or symptom that occurred during the conduct of the trial and safety follow-up.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

Capmatinib- randomized treatment

Reporting group description

Capmatinib- randomized treatment

Reporting group title

Capmatinib- extension treatment

Reporting group description

Capmatinib- extension treatment

Reporting group title

Docetaxel- randomized treatment

Reporting group description

Docetaxel- randomized treatment

Serious adverse events	Capmatinib- randomized treatment	Capmatinib- extension treatment	Docetaxel- randomized treatment
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 15 (20.00%)	1 / 5 (20.00%)	2 / 6 (33.33%)
number of deaths (all causes)	2	0	0
number of deaths resulting from adverse events	1	0	0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumonitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0
Infections and infestations
Respiratory tract infection
subjects affected / exposed	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Capmatinib- randomized treatment	Capmatinib- extension treatment	Docetaxel- randomized treatment
Total subjects affected by non serious adverse events
subjects affected / exposed	14 / 15 (93.33%)	4 / 5 (80.00%)	5 / 6 (83.33%)
Vascular disorders
Lymphoedema
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Hypotension
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Embolism
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Deep vein thrombosis
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
General disorders and administration site conditions
Suprapubic pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Pyrexia
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Peripheral swelling
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Oedema peripheral
subjects affected / exposed	10 / 15 (66.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	12	0	0
Oedema
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Mucosal inflammation
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Gait disturbance
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Fatigue
subjects affected / exposed	1 / 15 (6.67%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	1	1	1
Asthenia
subjects affected / exposed	4 / 15 (26.67%)	2 / 5 (40.00%)	2 / 6 (33.33%)
occurrences all number	4	3	3
Reproductive system and breast disorders
Perineal rash
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	2	2
Penile dermatitis
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Respiratory, thoracic and mediastinal disorders
Hiccups
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Haemoptysis
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Dyspnoea
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Dysphonia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Cough
subjects affected / exposed	5 / 15 (33.33%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	5	1	1
Aphonia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Pleural effusion
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Productive cough
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Rhinorrhoea
subjects affected / exposed	2 / 15 (13.33%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	2	1	1
Pneumonitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Anxiety
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Investigations
Blood lactate dehydrogenase increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Blood creatinine increased
subjects affected / exposed	4 / 15 (26.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	6	0	0
Blood cholesterol increased
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Blood bilirubin increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Blood albumin decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Aspartate aminotransferase increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Amylase increased
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	6	0	0
Alanine aminotransferase increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Creatinine renal clearance decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Creatinine renal clearance increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Hepatic enzyme increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Lipase increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Neutrophil count decreased
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Protein total decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Transaminases increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Weight decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Weight increased
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	4	0	0
White blood cell count decreased
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	3	3
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	0 / 15 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)
occurrences all number	0	0	2
Fall
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Cardiac disorders
Palpitations
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Atrial fibrillation
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Tachycardia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Supraventricular extrasystoles
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Pericardial effusion
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Nervous system disorders
Hypoaesthesia
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Dizziness
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	4	0	0
Dysgeusia
subjects affected / exposed	1 / 15 (6.67%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	1	1	1
Headache
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Somnolence
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Paraesthesia
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Neuropathy peripheral
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 15 (6.67%)	3 / 5 (60.00%)	3 / 6 (50.00%)
occurrences all number	1	3	3
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Hypoacusis
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Ear pain
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Deafness
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Eye disorders
Lacrimation increased
subjects affected / exposed	1 / 15 (6.67%)	2 / 5 (40.00%)	2 / 6 (33.33%)
occurrences all number	1	2	2
Eyelid oedema
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Eye pruritus
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Vitreous floaters
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	3 / 15 (20.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	3	1	1
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Gingival bleeding
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Frequent bowel movements
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Flatulence
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Nausea
subjects affected / exposed	5 / 15 (33.33%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	8	1	1
Dyspepsia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Dry mouth
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Diarrhoea
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	5	0	0
Constipation
subjects affected / exposed	4 / 15 (26.67%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	4	1	1
Aphthous ulcer
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Abdominal pain upper
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Faecaloma
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Toothache
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Stomatitis
subjects affected / exposed	1 / 15 (6.67%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	1	1	1
Odynophagia
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Vomiting
subjects affected / exposed	6 / 15 (40.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	7	0	0
Hepatobiliary disorders
Hypertransaminasaemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	1 / 15 (6.67%)	4 / 5 (80.00%)	4 / 6 (66.67%)
occurrences all number	1	4	4
Dermatosis
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Dry skin
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Night sweats
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Skin exfoliation
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Rash vesicular
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Pruritus
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	5	0	0
Photosensitivity reaction
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Pain of skin
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Onycholysis
subjects affected / exposed	0 / 15 (0.00%)	2 / 5 (40.00%)	2 / 6 (33.33%)
occurrences all number	0	2	2
Renal and urinary disorders
Nocturia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Dysuria
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Proteinuria
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Renal pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Endocrine disorders
Myxoedema
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Bone pain
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Back pain
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Arthralgia
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Myalgia
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	0	0
Osteoarthritis
subjects affected / exposed	1 / 15 (6.67%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	1	1	1
Osteochondrosis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Pain in extremity
subjects affected / exposed	3 / 15 (20.00%)	2 / 5 (40.00%)	2 / 6 (33.33%)
occurrences all number	5	2	2
Pain in jaw
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Scoliosis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Muscle spasms
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Infections and infestations
Conjunctivitis
subjects affected / exposed	0 / 15 (0.00%)	2 / 5 (40.00%)	2 / 6 (33.33%)
occurrences all number	0	2	2
COVID-19
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Bronchitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Eyelid infection
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Influenza
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Nasopharyngitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Sinusitis
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Rhinolaryngitis
subjects affected / exposed	0 / 15 (0.00%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	0	1	1
Respiratory tract infection
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Herpes zoster
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	4 / 15 (26.67%)	1 / 5 (20.00%)	1 / 6 (16.67%)
occurrences all number	5	1	1
Fluid retention
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Hyperglycaemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Hyperkalaemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Hypoalbuminaemia
subjects affected / exposed	3 / 15 (20.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	5	0	0
Hypocalcaemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0
Hypoproteinaemia
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Hyponatraemia
subjects affected / exposed	2 / 15 (13.33%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0
Hypomagnesaemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 5 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0

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Were there any global substantial amendments to the protocol? Yes

16 Dec 2020

This amendment included the following changes: Collection of post-progression patient-reported outcomes (PRO) were allowed to capture additional cancer related symptoms; mitigation procedures were added to ensure patient safety and trial integrity in the event of public emergencies such as COVID-19; the primary estimand-related attributes were rephrased to align with capmatinib program protocol standard language; comparison of overall response rate of capmatinib and docetaxel was set as key secondary objective as this would support the assessment of clinical benefit and the interpretation of the primary endpoint results; MET (and ALK, if applicable) testing while participant was still receiving anti-cancer therapy at pre-screening was allowed to facilitate recruitment; Novartis guidelines on Response Assessment in Neuro-oncology (RANO) for brain metastases were added as Appendix 2 to the protocol to support the secondary endpoint assessing intracranial anti-tumor activity of capmatinib in participants with central nervous system (CNS) lesions by blinded independent review committee (BIRC). The definitions of time-to-intracranial response (TTIR) and duration of intracranial response (DOIR) were updated accordingly.

24 Feb 2022

This amendment included the following changes: MET mutation status - to allow local results also from a validated test according to local regulation and documented as part of the participant’s medical record to be used for participant eligibility; serious adverse event (SAE)-reporting - immediate reporting clarified to align with health authority (especially with Federal Institute for Drugs and Medical Devices [BfArM]) requirements.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Progression-free Survival (PFS) per Blinded Independent Review Committee (BIRC) Using RECIST v1.1

Primary: Progression-free Survival (PFS) per Blinded Independent Review Committee (BIRC) Using RECIST v1.1

Secondary: Overall Response Rate (ORR) per RECIST 1.1 by Investigator

Secondary: Overall Response Rate (ORR) per RECIST 1.1 by Investigator

Secondary: Time to Response (TTR) per RECIST 1.1 by BIRC

Secondary: Time to Response (TTR) per RECIST 1.1 by BIRC

Secondary: Overall Response (ORR) per RECIST 1.1 by BIRC

Secondary: Overall Response (ORR) per RECIST 1.1 by BIRC

Secondary: Time to Response (TTR) per RECIST 1.1 by Investigator

Secondary: Time to Response (TTR) per RECIST 1.1 by Investigator

Secondary: Duration of Response (DOR) per RECIST 1.1 by BIRC

Secondary: Duration of Response (DOR) per RECIST 1.1 by BIRC

Secondary: Duration of Response (DOR) per RECIST 1.1 by Investigator

Secondary: Duration of Response (DOR) per RECIST 1.1 by Investigator

Secondary: Disease Control Rate (DCR) per RECIST 1.1 by BIRC

Secondary: Disease Control Rate (DCR) per RECIST 1.1 by BIRC

Secondary: Disease Control Rate (DCR) per RECIST 1.1 by Investigator

Secondary: Disease Control Rate (DCR) per RECIST 1.1 by Investigator

Secondary: Progression-free Survival (PFS) per Investigator Using RECIST v1.1

Secondary: Progression-free Survival (PFS) per Investigator Using RECIST v1.1

Secondary: Overall Survival (OS)

Secondary: Overall Survival (OS)

Secondary: Overall Intracranial Response Rate (OIRR)

Secondary: Overall Intracranial Response Rate (OIRR)

Secondary: Duration of Intracranial Response (DOIR)

Secondary: Duration of Intracranial Response (DOIR)

Secondary: Time to Intracranial Response (TTIR)

Secondary: Time to Intracranial Response (TTIR)

Secondary: Intracranial Disease Control Rate (IDCR)

Secondary: Intracranial Disease Control Rate (IDCR)

Secondary: Plasma Capmatinib Concentration

Secondary: Plasma Capmatinib Concentration

Secondary: Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Secondary: Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Secondary: Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

Secondary: Change from Baseline in Score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

Secondary: Change from Baseline in Score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Secondary: Change from Baseline in Score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Secondary: Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

Secondary: Time to Symptom Deterioration for Chest Pain, Cough and Dyspnea Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)

Secondary: Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Secondary: Time to Deterioration for Global Health Status /QoL Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Post-hoc: All Collected Deaths

Post-hoc: All Collected Deaths

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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