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Clinical Trial Results:
A Randomized Phase 2 Study of Abemaciclib (LY2835219) versus Docetaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated with Platinum-based Chemotherapy

Summary
EudraCT number	2014-004832-20
Trial protocol	DE ES HU IT PL FR RO
Global end of trial date	29 Jul 2020

Results information
Results version number	v1(current)
This version publication date	11 Aug 2021
First version publication date	11 Aug 2021
Other versions

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

I3Y-MC-JPBX

ISRCTN number

US NCT number

NCT02450539

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 15806

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

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

29 Jul 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

29 Jul 2020

Was the trial ended prematurely?

Main objective of the trial

The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

06 Aug 2015

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

23 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Romania: 22

Country: Number of subjects enrolled

Hungary: 13

Country: Number of subjects enrolled

United States: 6

Country: Number of subjects enrolled

Ukraine: 26

Country: Number of subjects enrolled

Russian Federation: 13

Country: Number of subjects enrolled

Spain: 14

Country: Number of subjects enrolled

Korea, Republic of: 9

Country: Number of subjects enrolled

Taiwan: 4

Country: Number of subjects enrolled

Poland: 24

Country: Number of subjects enrolled

Italy: 8

Country: Number of subjects enrolled

Australia: 4

Country: Number of subjects enrolled

France: 3

Country: Number of subjects enrolled

Germany: 13

Worldwide total number of subjects

159

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

No Text Available

Screening details

Study completers are participants who died due to any cause, were on follow-up at study completion or completed continued access period.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Abemaciclib

Arm description

200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Arm type

Experimental

Investigational medicinal product name

Abemaciclib

Investigational medicinal product code

Other name

LY2835219

Pharmaceutical forms

Capsule, Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally.

Docetaxel

Arm description

75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Arm type

Active comparator

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use

Dosage and administration details

Administered IV.

Number of subjects in period 1	Abemaciclib	Docetaxel
Started	106	53
Received at least one dose of study drug	106	52
Completed	90	46
Not completed	16	7
Consent withdrawn by subject	12	6
Lost to follow-up	4	1

Baseline characteristics

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Reporting group title

Abemaciclib

Reporting group description

200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Reporting group title

Docetaxel

Reporting group description

75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Reporting group values	Abemaciclib	Docetaxel	Total
Number of subjects	106	53	159
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	63.1 ± 7.8	64.5 ± 7.1	-
Gender categorical
Units: Subjects
Female	16	9	25
Male	90	44	134
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	5	3	8
Not Hispanic or Latino	84	48	132
Unknown or Not Reported	17	2	19
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	10	3	13
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	96	50	146
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment
Units: Subjects
Romania	18	4	22
Hungary	7	6	13
United States	4	2	6
Ukraine	13	13	26
Russia	11	2	13
Spain	8	6	14
South Korea	8	1	9
Taiwan	2	2	4
Poland	14	10	24
Italy	7	1	8
Australia	4	0	4
France	1	2	3
Germany	9	4	13
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Participants were stratified at randomization according to the following: Eastern Cooperative Oncology Group (ECOG) PS (0 vs. 1); number of prior therapies (received only platinum-based therapy vs. platinum-based therapy plus immune checkpoint inhibitor) and time since initiation of first line therapy (<=9 months vs >9 months). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
Units: Subjects
Zero (0)	22	7	29
One (1)	84	46	130

End points

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Reporting group title

Abemaciclib

Reporting group description

200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Reporting group title

Docetaxel

Reporting group description

75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Primary: Progression Free Survival (PFS)

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End point title

Progression Free Survival (PFS)

End point description

PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available. Analysis Population Description (APD): All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.

End point type

Primary

End point timeframe

Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	106	53
Units: months
median (confidence interval 95%)	2.53 (1.68 to 2.89)	4.21 (2.79 to 5.65)

Progression Free Survival (PFS)

Statistical analysis description

Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

159

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0068

Method

Stratified log-rank test.

Parameter type

Hazard ratio (HR)

Point estimate

1.765

Confidence interval

level

95%

sides

2-sided

lower limit

1.165

upper limit

2.672

Secondary: Pharmacokinetics (PK): Clearance of Abemaciclib

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End point title

Pharmacokinetics (PK): Clearance of Abemaciclib ^[1]

End point description

Pharmacokinetics (PK): Clearance of Abemaciclib Analysis Population Description: All participants who received abemaciclib and had evaluable PK data.

End point type

Secondary

End point timeframe

Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose

Notes
[1] - 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: Per protocol, statistical analysis (comparison analysis) were not planned for this outcome measure.

End point values	Abemaciclib
Number of subjects analysed	102
Units: Liters/hour (L/h)
geometric mean (geometric coefficient of variation)	21.3 ± 36

No statistical analyses for this end point

Secondary: PK: Volume of Distribution of Abemaciclib

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End point title

PK: Volume of Distribution of Abemaciclib ^[2]

End point description

PK: Volume of Distribution of Abemaciclib Analysis Population Description: All participants who received Abemaciclib and had evaluable PK data.

End point type

Secondary

End point timeframe

Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose

Notes
[2] - 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: Per protocol, statistical analysis (comparison analysis) were not planned for this outcome measure.

End point values	Abemaciclib
Number of subjects analysed	102
Units: Liters (L)
geometric mean (geometric coefficient of variation)	769 ± 51

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 randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. Analysis Population Description: All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib =35 and Docetaxel= 17.

End point type

Secondary

End point timeframe

Baseline to Date of Death from Any Cause (Up To 27 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	106	53
Units: Months
median (confidence interval 95%)	7 (5.00 to 8.78)	12.39 (7.13 to 15.98)

Overall Survival

Statistical analysis description

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

159

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.175

Method

Stratified log-rank test

Parameter type

Hazard ratio (HR)

Point estimate

1.333

Confidence interval

level

95%

sides

2-sided

lower limit

0.879

upper limit

2.022

Secondary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

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End point title

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

End point description

Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Analysis Population Description: All randomized participants.

End point type

Secondary

End point timeframe

Baseline to Objective Progression (Up To 6 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	106	53
Units: percentage participants
number (not applicable)	2.8	20.8

Overall Response Rate (ORR)

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

159

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

Method

Parameter type

Rate Difference

Point estimate

-17.9

Confidence interval

level

95%

sides

2-sided

lower limit

-29.3

upper limit

-6.6

Notes
[3] - Confidence intervals are based on the normal approximation to the binomial.

Secondary: Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

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End point title

Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

End point description

DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Analysis Population Description: All randomized participants.

End point type

Secondary

End point timeframe

Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	106	53
Units: percentage participants
number (not applicable)	50.9	64.2

Disease Control Rate (DCR)

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

159

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Stratified Log-rank test

Point estimate

-13.2

Confidence interval

level

95%

sides

2-sided

lower limit

-29.2

upper limit

2.8

Secondary: Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

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End point title

Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

End point description

Worsening of ECOG performance status is the duration from randomization to ECOG PFS of >/=2. Participants without an ECOG PFS >/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last). The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead. Analysis Population Description: All randomized participants. Participants censored: Abemaciclib =93 and Docetaxel= 43.

End point type

Secondary

End point timeframe

Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	106 ^[4]	53 ^[5]
Units: months
median (confidence interval 95%)	9999 (6.58 to 9999)	10.52 (4.64 to 9999)

Notes
[4] - 9999=NA. Due to insufficient data to support the analysis and the results.
[5] - 9999=NA. Due to insufficient data to support the analysis and the results.

Time to Worsening ECOG Performance Status of >/=2

Statistical analysis description

Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

159

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

P-value

= 0.7039

Method

Stratified Log Rank

Parameter type

Hazard ratio (HR)

Point estimate

1.184

Confidence interval

level

95%

sides

2-sided

lower limit

0.502

upper limit

2.792

Notes
[6] - Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).

Secondary: Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

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End point title

Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

End point description

MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score–minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment*visit,and baseline score. Group-level negative change from baseline indicated group improvement. All randomized participants for cycles which at least 25% of participants in each arm have a score.

End point type

Secondary

End point timeframe

Baseline through End of Study (Up To 6 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	87	43
Units: units on a scale
least squares mean (standard error)
Headache	0.19 ± 0.14	0.01 ± 0.18
Diarrhea	1.01 ± 0.18	0.15 ± 0.23
Mean core symptom severity	0.53 ± 0.14	0.00 ± 0.18
Mean interference	0.50 ± 0.20	0.18 ± 0.27
Mean lung cancer symptom severity	0.20 ± 0.12	-0.19 ± 0.15
Mean core plus lung cancer symptom severity	0.47 ± 0.13	-0.04 ± 0.17
Mean brain tumor symptom severity	0.19 ± 0.11	0.13 ± 0.15
Mean core plus lung worst 5 symptoms severity	-0.25 ± 0.17	-0.94 ± 0.22
Rash	0.28 ± 0.14	0.18 ± 0.17

MDASI-LC Scores - Headache

Statistical analysis description

Headache

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

Method

Parameter type

Mean difference (final values)

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-0.27

upper limit

0.62

Variability estimate

Standard error of the mean

Dispersion value

0.23

Notes
[7] - Headache

MDASI-LC Scores- Diarrhea

Statistical analysis description

Diarrhea

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

Method

Parameter type

Mean difference (final values)

Point estimate

0.86

Confidence interval

level

95%

sides

2-sided

lower limit

0.29

upper limit

1.43

Variability estimate

Standard error of the mean

Dispersion value

0.29

Notes
[8] - Diarrhea

MDASI-LC Scores - Mean core symptom severity

Statistical analysis description

Mean core symptom severity

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[9]

Method

Parameter type

Mean difference (final values)

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.09

upper limit

0.98

Variability estimate

Standard error of the mean

Dispersion value

0.22

Notes
[9] - Mean core symptom severity

MDASI-LC Scores - Mean interference

Statistical analysis description

Mean interference

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[10]

Method

Parameter type

Mean difference (final values)

Point estimate

0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-0.35

upper limit

0.99

Variability estimate

Standard error of the mean

Dispersion value

0.34

Notes
[10] - Mean interference

MDASI-LC Score - Mean lung cancer symptom severity

Statistical analysis description

Mean lung cancer symptom severity

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[11]

Method

Parameter type

Mean difference (final values)

Point estimate

0.39

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.77

Variability estimate

Standard error of the mean

Dispersion value

0.19

Notes
[11] - Mean lung cancer symptom severity

MDASI-LC Scores - Core plus lung cancer symptom

Statistical analysis description

Mean core plus lung cancer symptom severity

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[12]

Method

Parameter type

Mean difference (final values)

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.93

Variability estimate

Standard error of the mean

Dispersion value

0.21

Notes
[12] - Mean core plus lung cancer symptom severity

MDASI-LC Scores - Brain tumor symptom

Statistical analysis description

Mean brain tumor symptom severity

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[13]

Method

Parameter type

Mean difference (final values)

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-0.13

upper limit

0.43

Variability estimate

Standard error of the mean

Dispersion value

0.19

Notes
[13] - Mean brain tumor symptom severity

MDASI-LC Scores - Lung worst 5 symptoms severity

Statistical analysis description

Mean core plus lung worst 5 symptoms severity

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[14]

Method

Parameter type

Mean difference (final values)

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

0.14

upper limit

1.24

Variability estimate

Standard error of the mean

Dispersion value

0.28

Notes
[14] - Mean core plus lung worst 5 symptoms severity

MDASI-LC Scores - Rash

Statistical analysis description

Rash

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[15]

Method

Parameter type

Mean difference (final values)

Point estimate

0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-0.34

upper limit

0.53

Variability estimate

Standard error of the mean

Dispersion value

0.22

Notes
[15] - Rash

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

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End point title

Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

End point description

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment*visit, and baseline score. Group-level negative change from baseline indicated group improvement. Analysis Population Description: All randomized participants for cycles which at least 25% of participants in each arm have a score.

End point type

Secondary

End point timeframe

Baseline to Measured Progressive Disease (Up To 6 Months)

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	88	42
Units: units on a scale
least squares mean (standard error)	-5.49 ± 1.28	-2.36 ± 1.63

Change From Baseline in EQ5D5L VAS

Statistical analysis description

EQ VAS Overall Self-rated Health Score

Comparison groups

Abemaciclib v Docetaxel

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[16]

Method

Parameter type

Mean difference (final values)

Point estimate

-3.13

Confidence interval

level

95%

sides

2-sided

lower limit

-7.26

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.07

Notes
[16] - EQ VAS Overall Self-rated Health Score

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

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End point title

Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

End point description

There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment*visit, and baseline score.Group-level negative change from baseline indicated group improvement.

End point type

Secondary

End point timeframe

Baseline to Measured Progressive Disease (Up To 6 Months) Analysis population description: All randomized participants for cycles which at least 25% of participants in each arm have a score.

End point values	Abemaciclib	Docetaxel
Number of subjects analysed	88	42
Units: units on a scale
least squares mean (standard error)	-0.05 ± 0.02	-0.01 ± 0.02

Change From Baseline in EQ-5D-5L Index Value

Statistical analysis description

EQ-5D-5L Index Value

Comparison groups

Docetaxel v Abemaciclib

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority ^[17]

Method

Parameter type

Median difference (final values)

Point estimate

-0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.01

Variability estimate

Standard error of the mean

Dispersion value

0.03

Notes
[17] - EQ-5D-5L Index Value

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline Up To 5 Years

Adverse event reporting additional description

All randomized participants who received at least one dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.1

Reporting group title

Abemaciclib

Reporting group description

200 milligram(mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Reporting group title

Docetaxel

Reporting group description

75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Serious adverse events	Abemaciclib	Docetaxel
Total subjects affected by serious adverse events
subjects affected / exposed	29 / 106 (27.36%)	17 / 52 (32.69%)
number of deaths (all causes)	71	35
number of deaths resulting from adverse events	6	2
Vascular disorders
embolism
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	3 / 106 (2.83%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
hypotension
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
general physical health deterioration
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pyrexia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Immune system disorders
anaphylactic reaction
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
dyspnoea
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypoxia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
laryngeal haemorrhage
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pleural effusion
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
pneumonitis
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	3 / 106 (2.83%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
pulmonary haemorrhage
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Investigations
blood creatinine increased
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
international normalised ratio increased
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
ankle fracture
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
wrist fracture
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
cardiovascular insufficiency
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Nervous system disorders
cerebrovascular accident
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
dizziness
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
syncope
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
febrile neutropenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	3 / 52 (5.77%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
leukopenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	2 / 52 (3.85%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
neutropenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	4 / 52 (7.69%)
occurrences causally related to treatment / all	1 / 1	4 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
pancytopenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
constipation
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
diarrhoea
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	2 / 106 (1.89%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	2 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
gastric haemorrhage
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
nausea
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
oesophageal fistula
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
renal failure
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	2 / 106 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
muscular weakness
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
bronchitis
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
lung infection
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	6 / 106 (5.66%)	4 / 52 (7.69%)
occurrences causally related to treatment / all	2 / 6	2 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
myelitis
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
pleural infection
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
salmonella bacteraemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
upper respiratory tract infection
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
wound infection
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	0 / 106 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
dehydration
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hypokalaemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
hyponatraemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Abemaciclib	Docetaxel
Total subjects affected by non serious adverse events
subjects affected / exposed	94 / 106 (88.68%)	43 / 52 (82.69%)
Investigations
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	3 / 52 (5.77%)
occurrences all number	1	3
blood creatinine increased
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	13 / 106 (12.26%)	1 / 52 (1.92%)
occurrences all number	17	6
weight decreased
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	12 / 106 (11.32%)	6 / 52 (11.54%)
occurrences all number	13	6
Vascular disorders
hypotension
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	8 / 106 (7.55%)	0 / 52 (0.00%)
occurrences all number	8	0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	8 / 106 (7.55%)	3 / 52 (5.77%)
occurrences all number	10	3
headache
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	7 / 106 (6.60%)	2 / 52 (3.85%)
occurrences all number	7	2
neuropathy
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	3 / 106 (2.83%)	7 / 52 (13.46%)
occurrences all number	3	9
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	41 / 106 (38.68%)	12 / 52 (23.08%)
occurrences all number	47	18
leukopenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	10 / 106 (9.43%)	14 / 52 (26.92%)
occurrences all number	10	48
neutropenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	18 / 106 (16.98%)	26 / 52 (50.00%)
occurrences all number	20	76
thrombocytopenia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	27 / 106 (25.47%)	2 / 52 (3.85%)
occurrences all number	35	2
General disorders and administration site conditions
fatigue
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	30 / 106 (28.30%)	7 / 52 (13.46%)
occurrences all number	34	10
non-cardiac chest pain
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	8 / 106 (7.55%)	2 / 52 (3.85%)
occurrences all number	9	2
pain
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	3 / 52 (5.77%)
occurrences all number	1	3
pyrexia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	5 / 106 (4.72%)	4 / 52 (7.69%)
occurrences all number	5	4
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	8 / 106 (7.55%)	3 / 52 (5.77%)
occurrences all number	10	3
diarrhoea
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	41 / 106 (38.68%)	5 / 52 (9.62%)
occurrences all number	67	5
nausea
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	33 / 106 (31.13%)	7 / 52 (13.46%)
occurrences all number	35	10
vomiting
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	9 / 106 (8.49%)	3 / 52 (5.77%)
occurrences all number	11	3
Respiratory, thoracic and mediastinal disorders
cough
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	11 / 106 (10.38%)	2 / 52 (3.85%)
occurrences all number	11	2
dyspnoea
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	19 / 106 (17.92%)	6 / 52 (11.54%)
occurrences all number	20	6
laryngeal haemorrhage
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	9 / 106 (8.49%)	1 / 52 (1.92%)
occurrences all number	9	1
productive cough
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	6 / 106 (5.66%)	2 / 52 (3.85%)
occurrences all number	7	2
Skin and subcutaneous tissue disorders
alopecia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	1 / 106 (0.94%)	7 / 52 (13.46%)
occurrences all number	1	8
Musculoskeletal and connective tissue disorders
back pain
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	2 / 106 (1.89%)	3 / 52 (5.77%)
occurrences all number	2	3
muscular weakness
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	10 / 106 (9.43%)	7 / 52 (13.46%)
occurrences all number	12	8
Metabolism and nutrition disorders
decreased appetite
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	17 / 106 (16.04%)	7 / 52 (13.46%)
occurrences all number	19	7
hypokalaemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	8 / 106 (7.55%)	1 / 52 (1.92%)
occurrences all number	10	2
hyponatraemia
alternative dictionary used: MedDRA 23.1
subjects affected / exposed	7 / 106 (6.60%)	1 / 52 (1.92%)
occurrences all number	9	1

More information

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Were there any global substantial amendments to the protocol? Yes

08 Feb 2019

Protocol Amendment a: Added the dose modification guidance for hepatic enzyme alterations.

12 Feb 2020

Protocol Amendment b: Updates for dose adjustments for Interstitial Lung Disease (ILD)/Pneumonitis are safety-related.

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.

None reported

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Clinical trials

Clinical Trial Results:
A Randomized Phase 2 Study of Abemaciclib (LY2835219) versus Docetaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated with Platinum-based Chemotherapy

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Progression Free Survival (PFS)

Primary: Progression Free Survival (PFS)

Secondary: Pharmacokinetics (PK): Clearance of Abemaciclib

Secondary: Pharmacokinetics (PK): Clearance of Abemaciclib

Secondary: PK: Volume of Distribution of Abemaciclib

Secondary: PK: Volume of Distribution of Abemaciclib

Secondary: Overall Survival (OS)

Secondary: Overall Survival (OS)

Secondary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Secondary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Secondary: Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

Secondary: Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

Secondary: Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

Secondary: Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

Secondary: Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

Secondary: Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Randomized Phase 2 Study of Abemaciclib (LY2835219) versus Docetaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated with Platinum-based Chemotherapy

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Progression Free Survival (PFS)

Primary: Progression Free Survival (PFS)

Secondary: Pharmacokinetics (PK): Clearance of Abemaciclib

Secondary: Pharmacokinetics (PK): Clearance of Abemaciclib

Secondary: PK: Volume of Distribution of Abemaciclib

Secondary: PK: Volume of Distribution of Abemaciclib

Secondary: Overall Survival (OS)

Secondary: Overall Survival (OS)

Secondary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Secondary: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Secondary: Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

Secondary: Percentage of Participants who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)

Secondary: Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

Secondary: Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2

Secondary: Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

Secondary: Change from Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

Secondary: Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized Phase 2 Study of Abemaciclib (LY2835219) versus Docetaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated with Platinum-based Chemotherapy