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Clinical Trial Results:
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti−PD1 Antibody) Compared with Docetaxel in Patients with Non−Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

Summary
EudraCT number	2018-000245-39
Trial protocol	SK LT BG PL
Global end of trial date	18 Jan 2024

Results information
Results version number	v1(current)
This version publication date	01 Feb 2025
First version publication date	01 Feb 2025
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

BGB-A317-303

ISRCTN number

US NCT number

NCT03358875

WHO universal trial number (UTN)

Sponsor organisation name

BeiGene

Sponsor organisation address

1840 Gateway Drive, San Mateo, United States, 94404

Public contact

BeiGene USA, Inc., BeiGene Clinical Support, 1 877-828-5568, clinicaltrials@beigene.com

Scientific contact

BeiGene USA, Inc., BeiGene Clinical Support, 1 877-828-5568, clinicaltrials@beigene.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

18 Jan 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

18 Jan 2024

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy, as measured by overall survival (OS), of tislelizumab with docetaxel in the second- or third-line setting in patients with non-small cell lung cancer (NSCLC) who have progressed on a prior platinum-containing regimen. A comparison of the treatment arms will be performed in: o The intent-to-treat (ITT) analysis set o The program cell death protein ligand-1 (PD-L1) positive analysis set, where PD-L1 positive is defined as ≥ 25% of tumor cells (TCs) with PD-L1 membrane staining via the Ventana SP263 assay.

Protection of trial subjects

This study was conducted in accordance with BeiGene procedures, which comply with the principles of Good Clinical Practice (GCP), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, the Declaration of Helsinki, and local regulatory requirements. The protocol, any amendments, and informed consent forms (ICFs) were reviewed and approved by the Independent Ethics Committees (IEC)/Institutional Review Board (IRB) in conformance with GCP and applicable regulatory requirements. The IEC/IRB-approved ICF was signed and dated by the patient or the patient’s legally authorized representative before his or her participation in the study. A copy of each signed ICF was provided to the patient or the patient’s legally authorized representative.

Background therapy

Evidence for comparator

Actual start date of recruitment

30 Nov 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Brazil: 25

Country: Number of subjects enrolled

China: 641

Country: Number of subjects enrolled

Mexico: 14

Country: Number of subjects enrolled

New Zealand: 14

Country: Number of subjects enrolled

Russian Federation: 56

Country: Number of subjects enrolled

Türkiye: 39

Country: Number of subjects enrolled

Poland: 4

Country: Number of subjects enrolled

Slovakia: 5

Country: Number of subjects enrolled

Bulgaria: 2

Country: Number of subjects enrolled

Lithuania: 5

Worldwide total number of subjects

805

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)

523

From 65 to 84 years

281

85 years and over

Subject disposition

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Recruitment details

This study was conducted at 109 study centers in 10 countries (China, Brazil, Bulgaria, Lithuania, Mexico, New Zealand, Poland, Russia, Slovakia, and Turkey).

Screening details

Eligible participants were randomized in a 2:1 ratio to receive either tislelizumab or docetaxel treatment. Randomization was stratified by histology (squamous versus non--squamous), line of therapy (second line versus third line), and programmed cell death protein ligand-1 (PD-L1) expression (≥ 25% tumor cells (TCs) versus < 25% TCs).

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

Tislelizumab

Arm description

Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Tislelizumab

Investigational medicinal product code

BGB-A317

Other name

TEVIMBRA®

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Tislelizumab 200 mg administered intravenously once every 3 weeks.

Docetaxel

Arm description

Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Arm type

Active comparator

Investigational medicinal product name

Docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Docetaxel 75 mg/m² administered intravenously once every 3 weeks

Number of subjects in period 1	Tislelizumab	Docetaxel
Started	535	270
Received Treatment	534	258
Completed	0	0
Not completed	535	270
Study Closed by Sponsor	66	29
Consent withdrawn by subject	13	16
Death	409	223
Remained on Study	1	-
Miscellaneous	33	-
Lost to follow-up	13	2

Baseline characteristics

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Reporting group title

Tislelizumab

Reporting group description

Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Reporting group title

Docetaxel

Reporting group description

Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Reporting group values	Tislelizumab	Docetaxel	Total
Number of subjects	535	270	805
Age categorical
Units: Subjects
< 65 years	351	172	523
≥ 65 - < 75 years	167	86	253
≥ 75 - < 85 years	16	12	28
≥ 85 years	1	0	1
Age continuous
Units: years
arithmetic mean (standard deviation)	60.4 ( 8.879 )	60.27 ( 8.95 )	-
Gender categorical
Units: Subjects
Female	119	64	183
Male	416	206	622
Race
Units: Subjects
American Indian or Alaska Native	12	1	13
Asian	424	219	643
Black or African American	1	3	4
Native Hawaiian or Other Pacific Islander	3	3	6
White	93	44	137
Other	2	0	2
Histology
Units: Subjects
Squamous	248	122	370
Non-Squamous	287	148	435
Current Line of Therapy
Units: Subjects
Second	453	229	682
Third	82	41	123
PD-L1 Expression
Participants were tested for PD-L1 expression by a central laboratory using VENTANA SP263 immunohistochemistry assay.
Units: Subjects
≥ 25% of tumor cells	227	115	342
< 25% of tumor cells	307	152	459
Missing	1	3	4
Smoking Status
Units: Subjects
Never	162	82	244
Current	50	20	70
Former	323	168	491

End points

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Reporting group title

Tislelizumab

Reporting group description

Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Reporting group title

Docetaxel

Reporting group description

Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Primary: Overall Survival (OS) in All Participants (Co-primary Endpoint)

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End point title

Overall Survival (OS) in All Participants (Co-primary Endpoint)

End point description

OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization. The Intent-to-Treat (ITT) Analysis Set included all randomized patients.

End point type

Primary

End point timeframe

From randomization to the data cutoff date of 10 August 2020; up to 32.4 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	535	270
Units: months
median (confidence interval 95%)	17.2 (15.28 to 20.04)	11.9 (10.18 to 13.93)

Analysis of OS in All Participants

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

805

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[1]

Method

1-sided Log Rank Test

Parameter type

Hazard ratio (HR)

Point estimate

0.64

Confidence interval

level

95%

sides

2-sided

lower limit

0.527

upper limit

0.778

Notes
[1] - OS in the ITT population was tested at one-sided p value boundary of 0.0120. One-sided log rank test stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs <25% TC)

Primary: Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)

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End point title

Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)

End point description

OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization. The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining).

End point type

Primary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	227 ^[2]	115 ^[3]
Units: months
median (confidence interval 95%)	19.3 (16.49 to 22.60)	11.5 (8.15 to 13.54)

Notes
[2] - The PD-L1-Positive Analysis Set
[3] - The PD-L1-Positive Analysis Set

Analysis of OS in PD-L1-Positive Participants

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

342

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[4]

Method

1-sided Log Rank Test

Parameter type

Hazard ratio (HR)

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.407

upper limit

0.702

Notes
[4] - OS in the PD-L1 positive analysis set was tested at the one-sided p-value boundary of 0.025. One-sided log rank test stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).

Secondary: Objective Response Rate (ORR) in All Participants

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End point title

Objective Response Rate (ORR) in All Participants

End point description

Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.

End point type

Secondary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	535	270
Units: percentage of participants
number (confidence interval 95%)	22.6 (19.14 to 26.40)	7.0 (4.29 to 10.77)

Analysis of ORR in All Participants

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

805

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[5]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

3.86

Confidence interval

level

95%

sides

2-sided

lower limit

2.336

upper limit

6.393

Notes
[5] - Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, line of therapy, and PDL1 expression.

Secondary: Objective Response Rate in PD-L1-Positive Participants

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End point title

Objective Response Rate in PD-L1-Positive Participants

End point description

End point type

Secondary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	227 ^[6]	115 ^[7]
Units: percentage of participants
number (confidence interval 95%)	37.4 (31.13 to 44.09)	7.0 (3.05 to 13.25)

Notes
[6] - PD-L1-Positive Analysis Set
[7] - PD-L1-Positive Analysis Set

Analysis of ORR in PD-L1-Positive Participants

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

342

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

8.04

Confidence interval

level

95%

sides

2-sided

lower limit

3.721

upper limit

17.379

Notes
[8] - Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology and line of therapy.

Secondary: Duration of Response (DOR) for All Responders

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End point title

Duration of Response (DOR) for All Responders

End point description

DOR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.

End point type

Secondary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	121 ^[9]	19 ^[10]
Units: months
median (confidence interval 95%)	13.5 (8.54 to 19.58)	6.0 (2.10 to 7.16)

Notes
[9] - Participants in the Intent-to-Treat Analysis Set who had an objective response
[10] - Participants in the Intent-to-Treat Analysis Set who had an objective response

Analysis of DOR in All Responders

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

140

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[11]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.31

Confidence interval

level

95%

sides

2-sided

lower limit

0.176

upper limit

0.536

Notes
[11] - Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs <25% TC).

Secondary: Duration of Response (DOR) in PD-L1-Positive Responders

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End point title

Duration of Response (DOR) in PD-L1-Positive Responders

End point description

End point type

Secondary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	85 ^[12]	8 ^[13]
Units: months
median (confidence interval 95%)	11.9 (8.31 to 19.58)	4.2 (0.56 to 6.05)

Notes
[12] - Participants in the PD-L1-Positive Analysis Set who had an objective response
[13] - Participants in the PD-L1-Positive Analysis Set who had an objective response

Analysis of DOR in PD-L1-Positive Responders

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[14]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.16

Confidence interval

level

95%

sides

2-sided

lower limit

0.066

upper limit

0.37

Notes
[14] - Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).

Secondary: Progression-free Survival (PFS) in All Participants

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End point title

Progression-free Survival (PFS) in All Participants

End point description

PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

End point type

Secondary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	535	270
Units: months
median (confidence interval 95%)	4.2 (3.88 to 5.52)	2.6 (2.17 to 3.78)

Analysis of PFS in All Participants

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

805

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[15]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.528

upper limit

0.745

Notes
[15] - Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs <25% TC).

Secondary: Progression-free Survival in PD-L1 Positive Participants

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End point title

Progression-free Survival in PD-L1 Positive Participants

End point description

End point type

Secondary

End point timeframe

From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	227 ^[16]	115 ^[17]
Units: months
median (confidence interval 95%)	6.5 (6.24 to 8.28)	2.5 (2.10 to 4.11)

Notes
[16] - PD-L1 Positive Analysis Set
[17] - PD-L1 Positive Analysis Set

Analysis of PFS in PD-L1-Positive Participants

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

342

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[18]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.38

Confidence interval

level

95%

sides

2-sided

lower limit

0.285

upper limit

0.494

Notes
[18] - Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).

Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score

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End point title

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score

End point description

The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and two global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS/QoL score indicates better quality of life. The health-related quality of life (HRQoL) Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment.

End point type

Secondary

End point timeframe

Baseline and Cycle 6 (each cycle was 3 weeks)

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	316 ^[19]	76 ^[20]
Units: score on a scale
least squares mean (confidence interval 95%)	2.4 (0.62 to 4.12)	-3.4 (-6.45 to -0.27)

Notes
[19] - Participants in the HRQoL Analysis set with available data at Baseline and Cycle 6
[20] - Participants in the HRQoL Analysis set with available data at Baseline and Cycle 6

Analysis of EORTC QLQ-C30 GHS/QoL Score

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

392

Analysis specification

Pre-specified

Analysis type

other ^[21]

P-value

= 0.0008

Method

Mixed models analysis

Parameter type

Least Squares (LS) Mean Difference

Point estimate

5.7

Confidence interval

level

95%

sides

2-sided

lower limit

2.38

upper limit

9.07

Notes
[21] - The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.

Secondary: Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores

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End point title

Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores

End point description

The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms. The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment.

End point type

Secondary

End point timeframe

Baseline and Cycle 6 (each cycle was 3 weeks)

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	316 ^[22]	77 ^[23]
Units: score on a scale
least squares mean (confidence interval 95%)
Coughing Scale	-7.8 (-10.23 to -5.30)	0.5 (-3.87 to 4.87)
Dyspnoea Scale	-1.2 (-2.93 to 0.56)	2.0 (-1.01 to 5.05)
Chest Pain Scale	-0.9 (-2.86 to 1.06)	1.3 (-2.15 to 4.84)

Notes
[22] - Participants in the HRQoL Analysis Set with available data at Baseline and Cycle 6
[23] - Participants in the HRQoL Analysis Set with available data at Baseline and Cycle 6

Analysis of EORTC QLQ-LC13 Coughing Scale

Statistical analysis description

The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0007

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

-8.3

Confidence interval

level

95%

sides

2-sided

lower limit

-13.02

upper limit

-3.51

Analysis of EORTC QLQ-LC13 Dyspnoea Scale

Statistical analysis description

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0579

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

-3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-6.52

upper limit

0.11

Analysis of EORTC QLQ-LC13 Chest Pain Scale

Statistical analysis description

Comparison groups

Tislelizumab v Docetaxel

Number of subjects included in analysis

393

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.2472

Method

Mixed models analysis

Parameter type

LS Mean Difference

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-6.05

upper limit

1.56

Secondary: Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)

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End point title

Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)

End point description

The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

End point type

Secondary

End point timeframe

Baseline and Cycle 6 (each cycle was 3 weeks)

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	237 ^[24]	60 ^[25]
Units: score on a scale
arithmetic mean (standard deviation)	1.0 ( 11.89 )	1.7 ( 11.36 )

Notes
[24] - Participants in the HRQoL Analysis Set with available data at Baseline and Cycle 6
[25] - Participants in the HRQoL Analysis Set with available data at Baseline and Cycle 6

No statistical analyses for this end point

Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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End point title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

End point description

The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below: -Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. -Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. -Grade 3: Severe or medically significant but not immediately life threatening. hospitalization or prolongation of hospitalization indicated; disabling; limiting selfcare activities of daily living. -Grade 4: Life threatening consequences; urgent intervention indicated. -Grade 5: Death related to AE. The Safety Analysis Set included all randomized patients who received ≥ 1 dose of study drug.

End point type

Secondary

End point timeframe

From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months)

End point values	Tislelizumab	Docetaxel
Number of subjects analysed	534 ^[26]	258 ^[27]
Units: participants
Any TEAE	518	254
≥ Grade 3 TEAE	233	193

Notes
[26] - Safety Analysis Set
[27] - Safety Analysis Set

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From first dose of study treatment until 30 days after the last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.

Adverse event reporting additional description

Deaths, serious adverse events, and non-serious adverse events are reported for all randomized participants who received ≥ 1 dose of any study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Docetaxel

Reporting group description

Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Reporting group title

Tislelizumab

Reporting group description

Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Serious adverse events	Docetaxel	Tislelizumab
Total subjects affected by serious adverse events
subjects affected / exposed	84 / 258 (32.56%)	192 / 534 (35.96%)
number of deaths (all causes)	219	409
number of deaths resulting from adverse events	12	35
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peritumoural oedema
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour associated fever
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour pain
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Embolism venous
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Superior vena cava syndrome
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	2 / 258 (0.78%)	6 / 534 (1.12%)
occurrences causally related to treatment / all	1 / 2	2 / 6
deaths causally related to treatment / all	1 / 2	2 / 6
Chills
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 258 (0.00%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 258 (0.39%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	1 / 258 (0.39%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	1 / 1	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Non-cardiac chest pain
subjects affected / exposed	1 / 258 (0.39%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	2 / 258 (0.78%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	1 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Hypoxia
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haemoptysis
subjects affected / exposed	4 / 258 (1.55%)	10 / 534 (1.87%)
occurrences causally related to treatment / all	2 / 4	2 / 11
deaths causally related to treatment / all	0 / 1	0 / 0
Dyspnoea
subjects affected / exposed	5 / 258 (1.94%)	8 / 534 (1.50%)
occurrences causally related to treatment / all	0 / 5	1 / 8
deaths causally related to treatment / all	0 / 2	0 / 0
Cough
subjects affected / exposed	0 / 258 (0.00%)	4 / 534 (0.75%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune-mediated lung disease
subjects affected / exposed	0 / 258 (0.00%)	8 / 534 (1.50%)
occurrences causally related to treatment / all	0 / 0	8 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Interstitial lung disease
subjects affected / exposed	0 / 258 (0.00%)	7 / 534 (1.31%)
occurrences causally related to treatment / all	0 / 0	7 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary thrombosis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary oedema
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pulmonary embolism
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	5 / 258 (1.94%)	9 / 534 (1.69%)
occurrences causally related to treatment / all	0 / 6	2 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Pneumonitis
subjects affected / exposed	0 / 258 (0.00%)	15 / 534 (2.81%)
occurrences causally related to treatment / all	0 / 0	14 / 15
deaths causally related to treatment / all	0 / 0	1 / 1
Wheezing
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheal stenosis
subjects affected / exposed	0 / 258 (0.00%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Respiratory failure
subjects affected / exposed	3 / 258 (1.16%)	6 / 534 (1.12%)
occurrences causally related to treatment / all	1 / 3	2 / 6
deaths causally related to treatment / all	0 / 0	2 / 6
Psychiatric disorders
Suicide attempt
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Investigations
Aspartate aminotransferase increased
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase increased
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neutrophil count decreased
subjects affected / exposed	8 / 258 (3.10%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	10 / 10	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Platelet count decreased
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
White blood cell count decreased
subjects affected / exposed	4 / 258 (1.55%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	4 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Cerebral radiation injury
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Limb injury
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 258 (0.39%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 2
Acute left ventricular failure
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Acute coronary syndrome
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiogenic shock
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 258 (0.39%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 258 (0.00%)	5 / 534 (0.94%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Nervous system disorders
Brain oedema
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cerebral infarction
subjects affected / exposed	0 / 258 (0.00%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 2
Epilepsy
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial pressure increased
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual pathway disorder
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Agranulocytosis
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia
subjects affected / exposed	5 / 258 (1.94%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	5 / 5	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	6 / 258 (2.33%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	7 / 7	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	21 / 258 (8.14%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	22 / 22	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 258 (0.39%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenitis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	11 / 258 (4.26%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	12 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Retinal tear
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 258 (0.00%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 258 (0.39%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Immune-mediated enterocolitis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 258 (0.00%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Acute hepatic failure
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cholecystitis
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Autoimmune hepatitis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic function abnormal
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	1 / 1
Drug-induced liver injury
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (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
Urinary retention
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	1 / 258 (0.39%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	1 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Immune-mediated adrenal insuficiency
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal insufficiency
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Glucocorticoid deficiency
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 258 (0.39%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone pain
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (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
COVID-19
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 258 (0.39%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	19 / 258 (7.36%)	39 / 534 (7.30%)
occurrences causally related to treatment / all	12 / 21	6 / 48
deaths causally related to treatment / all	1 / 2	2 / 6
Pneumonia haemophilus
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Upper respiratory tract infection
subjects affected / exposed	2 / 258 (0.78%)	3 / 534 (0.56%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 258 (0.00%)	5 / 534 (0.94%)
occurrences causally related to treatment / all	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 258 (0.00%)	2 / 534 (0.37%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 258 (0.39%)	0 / 534 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoproteinaemia
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ketoacidosis
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	0 / 258 (0.00%)	1 / 534 (0.19%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Docetaxel	Tislelizumab
Total subjects affected by non serious adverse events
subjects affected / exposed	246 / 258 (95.35%)	498 / 534 (93.26%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
subjects affected / exposed	8 / 258 (3.10%)	21 / 534 (3.93%)
occurrences all number	9	25
Vascular disorders
Hypertension
subjects affected / exposed	1 / 258 (0.39%)	25 / 534 (4.68%)
occurrences all number	1	32
General disorders and administration site conditions
Chest pain
subjects affected / exposed	2 / 258 (0.78%)	21 / 534 (3.93%)
occurrences all number	2	21
Chest discomfort
subjects affected / exposed	8 / 258 (3.10%)	19 / 534 (3.56%)
occurrences all number	8	19
Asthenia
subjects affected / exposed	57 / 258 (22.09%)	76 / 534 (14.23%)
occurrences all number	64	78
Malaise
subjects affected / exposed	17 / 258 (6.59%)	40 / 534 (7.49%)
occurrences all number	28	44
Fatigue
subjects affected / exposed	24 / 258 (9.30%)	37 / 534 (6.93%)
occurrences all number	31	40
Pyrexia
subjects affected / exposed	26 / 258 (10.08%)	62 / 534 (11.61%)
occurrences all number	29	72
Non-cardiac chest pain
subjects affected / exposed	7 / 258 (2.71%)	22 / 534 (4.12%)
occurrences all number	9	29
Oedema peripheral
subjects affected / exposed	10 / 258 (3.88%)	15 / 534 (2.81%)
occurrences all number	11	15
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	40 / 258 (15.50%)	111 / 534 (20.79%)
occurrences all number	46	128
Dyspnoea
subjects affected / exposed	31 / 258 (12.02%)	62 / 534 (11.61%)
occurrences all number	35	64
Haemoptysis
subjects affected / exposed	17 / 258 (6.59%)	51 / 534 (9.55%)
occurrences all number	18	62
Productive cough
subjects affected / exposed	22 / 258 (8.53%)	36 / 534 (6.74%)
occurrences all number	22	49
Psychiatric disorders
Insomnia
subjects affected / exposed	26 / 258 (10.08%)	34 / 534 (6.37%)
occurrences all number	29	58
Investigations
Alanine aminotransferase increased
subjects affected / exposed	39 / 258 (15.12%)	112 / 534 (20.97%)
occurrences all number	47	183
Aspartate aminotransferase increased
subjects affected / exposed	32 / 258 (12.40%)	106 / 534 (19.85%)
occurrences all number	38	172
Bilirubin conjugated increased
subjects affected / exposed	7 / 258 (2.71%)	17 / 534 (3.18%)
occurrences all number	9	25
Blood alkaline phosphatase increased
subjects affected / exposed	10 / 258 (3.88%)	39 / 534 (7.30%)
occurrences all number	13	53
Blood bilirubin increased
subjects affected / exposed	15 / 258 (5.81%)	36 / 534 (6.74%)
occurrences all number	23	49
Blood creatine phosphokinase MB increased
subjects affected / exposed	1 / 258 (0.39%)	21 / 534 (3.93%)
occurrences all number	1	34
Blood creatine phosphokinase increased
subjects affected / exposed	2 / 258 (0.78%)	47 / 534 (8.80%)
occurrences all number	4	97
Blood creatinine increased
subjects affected / exposed	17 / 258 (6.59%)	37 / 534 (6.93%)
occurrences all number	22	58
Blood lactate dehydrogenase increased
subjects affected / exposed	18 / 258 (6.98%)	38 / 534 (7.12%)
occurrences all number	23	48
Blood thyroid stimulating hormone increased
subjects affected / exposed	3 / 258 (1.16%)	32 / 534 (5.99%)
occurrences all number	3	56
Blood urea increased
subjects affected / exposed	7 / 258 (2.71%)	26 / 534 (4.87%)
occurrences all number	7	38
Gamma-glutamyltransferase increased
subjects affected / exposed	15 / 258 (5.81%)	31 / 534 (5.81%)
occurrences all number	19	47
Lymphocyte count decreased
subjects affected / exposed	18 / 258 (6.98%)	35 / 534 (6.55%)
occurrences all number	37	76
Neutrophil count decreased
subjects affected / exposed	90 / 258 (34.88%)	17 / 534 (3.18%)
occurrences all number	168	38
White blood cell count increased
subjects affected / exposed	11 / 258 (4.26%)	20 / 534 (3.75%)
occurrences all number	13	30
White blood cell count decreased
subjects affected / exposed	75 / 258 (29.07%)	21 / 534 (3.93%)
occurrences all number	133	58
Weight decreased
subjects affected / exposed	31 / 258 (12.02%)	90 / 534 (16.85%)
occurrences all number	32	101
Neutrophil count increased
subjects affected / exposed	7 / 258 (2.71%)	19 / 534 (3.56%)
occurrences all number	9	23
Platelet count decreased
subjects affected / exposed	9 / 258 (3.49%)	21 / 534 (3.93%)
occurrences all number	11	37
Nervous system disorders
Dizziness
subjects affected / exposed	13 / 258 (5.04%)	19 / 534 (3.56%)
occurrences all number	15	21
Headache
subjects affected / exposed	12 / 258 (4.65%)	23 / 534 (4.31%)
occurrences all number	12	28
Hypoaesthesia
subjects affected / exposed	13 / 258 (5.04%)	6 / 534 (1.12%)
occurrences all number	13	6
Peripheral sensory neuropathy
subjects affected / exposed	9 / 258 (3.49%)	0 / 534 (0.00%)
occurrences all number	10	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	114 / 258 (44.19%)	156 / 534 (29.21%)
occurrences all number	169	269
Neutropenia
subjects affected / exposed	73 / 258 (28.29%)	10 / 534 (1.87%)
occurrences all number	185	24
Leukopenia
subjects affected / exposed	70 / 258 (27.13%)	17 / 534 (3.18%)
occurrences all number	169	38
Febrile neutropenia
subjects affected / exposed	13 / 258 (5.04%)	0 / 534 (0.00%)
occurrences all number	13	0
Thrombocytopenia
subjects affected / exposed	9 / 258 (3.49%)	20 / 534 (3.75%)
occurrences all number	22	28
Eye disorders
Cataract
subjects affected / exposed	1 / 258 (0.39%)	22 / 534 (4.12%)
occurrences all number	1	23
Gastrointestinal disorders
Stomatitis
subjects affected / exposed	12 / 258 (4.65%)	6 / 534 (1.12%)
occurrences all number	14	6
Nausea
subjects affected / exposed	43 / 258 (16.67%)	65 / 534 (12.17%)
occurrences all number	55	73
Diarrhoea
subjects affected / exposed	35 / 258 (13.57%)	41 / 534 (7.68%)
occurrences all number	51	52
Constipation
subjects affected / exposed	44 / 258 (17.05%)	74 / 534 (13.86%)
occurrences all number	51	89
Abdominal pain upper
subjects affected / exposed	10 / 258 (3.88%)	16 / 534 (3.00%)
occurrences all number	11	20
Abdominal distension
subjects affected / exposed	12 / 258 (4.65%)	8 / 534 (1.50%)
occurrences all number	14	8
Toothache
subjects affected / exposed	6 / 258 (2.33%)	20 / 534 (3.75%)
occurrences all number	7	23
Vomiting
subjects affected / exposed	19 / 258 (7.36%)	35 / 534 (6.55%)
occurrences all number	23	44
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	7 / 258 (2.71%)	38 / 534 (7.12%)
occurrences all number	7	41
Pruritus
subjects affected / exposed	5 / 258 (1.94%)	41 / 534 (7.68%)
occurrences all number	5	44
Alopecia
subjects affected / exposed	127 / 258 (49.22%)	7 / 534 (1.31%)
occurrences all number	130	7
Renal and urinary disorders
Proteinuria
subjects affected / exposed	6 / 258 (2.33%)	17 / 534 (3.18%)
occurrences all number	6	26
Endocrine disorders
Hyperthyroidism
subjects affected / exposed	0 / 258 (0.00%)	23 / 534 (4.31%)
occurrences all number	0	23
Hypothyroidism
subjects affected / exposed	2 / 258 (0.78%)	66 / 534 (12.36%)
occurrences all number	2	82
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	23 / 258 (8.91%)	68 / 534 (12.73%)
occurrences all number	30	83
Back pain
subjects affected / exposed	20 / 258 (7.75%)	41 / 534 (7.68%)
occurrences all number	21	47
Pain in extremity
subjects affected / exposed	17 / 258 (6.59%)	29 / 534 (5.43%)
occurrences all number	23	36
Myalgia
subjects affected / exposed	16 / 258 (6.20%)	6 / 534 (1.12%)
occurrences all number	19	6
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	23 / 258 (8.91%)	55 / 534 (10.30%)
occurrences all number	25	76
Pneumonia
subjects affected / exposed	18 / 258 (6.98%)	40 / 534 (7.49%)
occurrences all number	19	43
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	62 / 258 (24.03%)	88 / 534 (16.48%)
occurrences all number	71	95
Hypocalcaemia
subjects affected / exposed	21 / 258 (8.14%)	29 / 534 (5.43%)
occurrences all number	26	49
Hyperglycaemia
subjects affected / exposed	29 / 258 (11.24%)	56 / 534 (10.49%)
occurrences all number	37	111
Hyperuricaemia
subjects affected / exposed	7 / 258 (2.71%)	24 / 534 (4.49%)
occurrences all number	10	52
Hypoalbuminaemia
subjects affected / exposed	40 / 258 (15.50%)	76 / 534 (14.23%)
occurrences all number	64	141
Hypoproteinaemia
subjects affected / exposed	7 / 258 (2.71%)	22 / 534 (4.12%)
occurrences all number	8	27
Hypophosphataemia
subjects affected / exposed	9 / 258 (3.49%)	11 / 534 (2.06%)
occurrences all number	16	25
Hyponatraemia
subjects affected / exposed	28 / 258 (10.85%)	53 / 534 (9.93%)
occurrences all number	37	85
Hypokalaemia
subjects affected / exposed	14 / 258 (5.43%)	51 / 534 (9.55%)
occurrences all number	16	83
Hypochloraemia
subjects affected / exposed	11 / 258 (4.26%)	19 / 534 (3.56%)
occurrences all number	13	29

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Were there any global substantial amendments to the protocol? Yes

14 Feb 2018

Amendment 1.0 Key Changes: • Expanded the study to allow the enrollment of about 160 patients outside of China, including Brazil, Bulgaria, Lithuania, Mexico, New Zealand, Poland, Russia, Slovakia, and Turkey. • OS in PD-L1-positive (≥ 25% TCs) population were changed to be tested at a significance level of 0.007 as the dual primary endpoint. • Updated the planned timing and number of death events for interim and final analyses of OS. • Removed analysis of PD-L1-positive (≥ 25% TCs) population from interim analysis. • Revised to cap the PD-L1 negative (< 25% TCs) population to about 60% of ITT population. • Revised the timing of collection of all immune-mediated adverse events (imAEs) and SAEs related to tislelizumab. • Added ophthalmologic exams. • Added questionnaire EQ-5D-5L.

22 May 2018

Amendment 1.0 Addendum 1 Key Changes: • Added myocarditis and myositis/rhabdomyolysis as potential imAEs and provided guidelines for their diagnostic tests and management. • Added monitoring of serum creatine kinase and creatine kinase cardiac muscle isoenzyme.

20 Jul 2018

Amendment 2.0 Key Changes: • Revised exclusion criteria pertaining to chemotherapy and herbal medicine. • Clarified inclusion/exclusion criteria including lines of prior anticancer therapy, wash out period for prior anticancer chemotherapy, herbal medicine, immunotherapy, and radiation. • Added inclusion criterion of ≥ 12 weeks life expectancy. • Added antibiotics wash-out period of 2 weeks prior to randomization. • Added guidance on the assessment of pulmonary function.

09 Mar 2020

Amendment 3.0 Key Changes: • Updated the planned timing and number of death events for interim and final analyses of OS • Added symptom scale of QLQ-LC13 to health-related quality of life (HRQoL) measures in statistical analysis • Clarified the definition of window of baseline tumor assessment in screening period • Added tumor-infiltrating immune cells as exploratory biomarker for efficacy

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 Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti−PD1 Antibody) Compared with Docetaxel in Patients with Non−Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Overall Survival (OS) in All Participants (Co-primary Endpoint)

Primary: Overall Survival (OS) in All Participants (Co-primary Endpoint)

Primary: Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)

Primary: Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)

Secondary: Objective Response Rate (ORR) in All Participants

Secondary: Objective Response Rate (ORR) in All Participants

Secondary: Objective Response Rate in PD-L1-Positive Participants

Secondary: Objective Response Rate in PD-L1-Positive Participants

Secondary: Duration of Response (DOR) for All Responders

Secondary: Duration of Response (DOR) for All Responders

Secondary: Duration of Response (DOR) in PD-L1-Positive Responders

Secondary: Duration of Response (DOR) in PD-L1-Positive Responders

Secondary: Progression-free Survival (PFS) in All Participants

Secondary: Progression-free Survival (PFS) in All Participants

Secondary: Progression-free Survival in PD-L1 Positive Participants

Secondary: Progression-free Survival in PD-L1 Positive Participants

Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score

Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score

Secondary: Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores

Secondary: Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores

Secondary: Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)

Secondary: Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)

Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

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Clinical Trial Results:
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti−PD1 Antibody) Compared with Docetaxel in Patients with Non−Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen