A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

• ClinicalTrials.gov Identifier: NCT03430843
• Recruitment Status: Completed
• First Posted: February 13, 2018
• Results First Posted: December 29, 2023
• Last Update Posted: December 29, 2023
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Esophageal Squamous Cell Carcinoma (ESCC)
• Interventions: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan
• Enrollment: 512

Participant Flow

Recruitment Details	This study was conducted at 132 study centers in Mainland China, Taiwan, United States, France, Italy, Germany, Spain, Japan, South Korea, Belgium and the United Kingdom.
Pre-assignment Details

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Period Title: Overall Study
Started	256	256
Treated	255	240
Completed	0	0
Not Completed	256	256
Reason Not Completed
Death	233	233
Sponsor Decision	17	6
Withdrawal by Subject	5	14
Lost to Follow-up	1	3

Baseline Characteristics

Arm/Group Title		Tislelizumab	Investigator Chosen Chemotherapy	Total
Arm/Group Description		Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days	Total of all reporting groups
Overall Number of Baseline Participants		256	256	512
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	256 participants	256 participants	512 participants
		61.8 (8.41)	61.8 (8.02)	61.8 (8.21)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	256 participants	256 participants	512 participants
	Female	39 15.2%	41 16.0%	80 15.6%
	Male	217 84.8%	215 84.0%	432 84.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	256 participants	256 participants	512 participants
	Hispanic or Latino	2 0.8%	2 0.8%	4 0.8%
	Not Hispanic or Latino	252 98.4%	252 98.4%	504 98.4%
	Unknown or Not Reported	2 0.8%	2 0.8%	4 0.8%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	256 participants	256 participants	512 participants
	Asian	201 78.5%	207 80.9%	408 79.7%
	White or Caucasian	53 20.7%	44 17.2%	97 18.9%
	Not Reported	1 0.4%	0 0.0%	1 0.2%
	Unknown	1 0.4%	2 0.8%	3 0.6%
	Black or African American	0 0.0%	2 0.8%	2 0.4%
	Other	0 0.0%	1 0.4%	1 0.2%
Eastern Cooperative Oncology Group (ECOG) Performance Status Score [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	256 participants	256 participants	512 participants
	0	66 25.8%	61 23.8%	127 24.8%
	1	190 74.2%	195 76.2%	385 75.2%
		[1] Measure Description: Measure Description: ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
PD-L1 Expression Status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	256 participants	256 participants	512 participants
	vCPS >= 10%	80 31.3%	62 24.2%	142 27.7%
	vCPS < 10%	100 39.1%	122 47.7%	222 43.4%
	Missing	76 29.7%	72 28.1%	148 28.9%
		[1] Measure Description: Measure Description: Programmed death ligand 1 (PD-L1) positive is defined as visually-estimated Combined Positive Score (vCPS) >= 10%, PD-L1 negative is defined as vCPS < 10%, PD-L1 missing refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample. Note terminology was updated from vCPS to Tumor Area Positivity (TAP) score in manuscripts.

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set
Description	OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
Time Frame	Approximately 2 years and 10 months from date of first randomization

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	256	256
Median (95% Confidence Interval); Unit of Measure: Months
	8.6; (7.5 to 10.4)	6.3; (5.3 to 7.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tislelizumab, Investigator Chosen Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	1-sided, Log Rank Test
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.85
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Overall Survival (OS) in the PDL-1 Positive Analysis Set
Description	OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population included all randomized participants with tumor PD-L1 vCPS ≥10%

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	80	62
Median (95% Confidence Interval); Unit of Measure: Months
	10.2; (8.5 to 14.5)	5.1; (3.8 to 8.2)

3. Secondary Outcome

Title	Objective Response Rate (ORR) in the ITT Analysis Set
Description	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	256	256
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	20.3; (15.6 to 25.8)	9.8; (6.4 to 14.1)

4. Secondary Outcome

Title	Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets
Description	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	80	62
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	26.3; (17 to 37.3)	11.3; (4.7 to 21.9)

5. Secondary Outcome

Title	Progression-free Survival (PFS) in the ITT Analysis Set
Description	PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	256	256
Median (95% Confidence Interval); Unit of Measure: Months
	1.6; (1.4 to 2.7)	2.1; (1.5 to 2.7)

6. Secondary Outcome

Title	Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set
Description	PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	80	62
Median (95% Confidence Interval); Unit of Measure: Months
	2.7; (1.5 to 4.2)	2.3; (1.4 to 3.0)

7. Secondary Outcome

Title	Duration of Response (DOR) in the ITT Analysis Set
Description	DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	52	25
Median (95% Confidence Interval); Unit of Measure: Months
	7.1; (4.1 to 11.3)	4.0; (2.1 to 8.2)

8. Secondary Outcome

Title	Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
Description	DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Time Frame	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	21	7
Median (95% Confidence Interval); Unit of Measure: Months
	7.1; (2.9 to 13.2)	5.7 [1]; (1.2 to NA)

[1]

Not estimable due to insufficient number of participants with events

9. Secondary Outcome

Title	Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set
Description	Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Time Frame	Baseline to Cycle 6 (21 days per cycle)

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Arm/Group Title		Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:		Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed		239	246
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	Number Analyzed	239 participants	246 participants
		16.2 (12.28)	18.3 (13.86)
Change at Cycle 6	Number Analyzed	98 participants	36 participants
		0.2 (8.28)	4.8 (9.38)

10. Secondary Outcome

Title	HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
Description	Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Time Frame	Baseline to Cycle 6 (21 days per cycle)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Arm/Group Title		Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:		Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed		77	59
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	Number Analyzed	77 participants	59 participants
		16.8 (10.96)	18.8 (12.02)
Change at Cycle 6	Number Analyzed	39 participants	9 participants
		0.5 (7.39)	0.5 (4.86)

11. Secondary Outcome

Title	HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
Description	Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Time Frame	Baseline to Cycle 6 (21 days per cycle)

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	239	246
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	14.7 (11.81)	16.3 (13.20)
Change at Cycle 6	-0.6 (8.63)	3.0 (12.05)

12. Secondary Outcome

Title	HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.
Description	Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Time Frame	Baseline to Cycle 6 (21 days per cycle)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	76	59
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	16.5 (12.69)	18.1 (12.21)
Change at Cycle 6	-0.9 (7.45)	-2.9 (5.16)

13. Secondary Outcome

Title	HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set
Description	Mean change from baseline in EQ-5D-5L visual acuity score (VAS). 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.
Time Frame	Baseline to Cycle 6 (21 days per cycle)

Outcome Measure Data

Analysis Population Description

The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	242	247
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	73.7 (17.05)	72.5 (18.13)
Change at Cycle 6	-0.6 (14.81)	-5.9 (16.34)

14. Secondary Outcome

Title	HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set
Description	Mean change from baseline in EQ-5D-5L visual acuity score (VAS). 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.
Time Frame	Baseline to Cycle 6 (21 days per cycle)

Outcome Measure Data

Analysis Population Description

The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	78	59
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline	74.1 (14.84)	70.5 (18.40)
Change at Cycle 6	-0.5 (17.59)	4.4 (12.82)

15. Secondary Outcome

Title	Number of Participants Experiencing Adverse Events (AEs)
Description	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
Time Frame	From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received ≥ 1 dose of study drug

Arm/Group Title	Tislelizumab	Investigator Chosen Chemotherapy
Arm/Group Description:	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
Overall Number of Participants Analyzed	255	240
Measure Type: Number; Unit of Measure: Participants
Number of participants with TEAEs	245	236
Number of participants with SAEs	109	106

Adverse Events

Time Frame	All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
Adverse Event Reporting Description	All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Arm/Group Title	Tislelizumab		Investigator Chosen Chemotherapy (ICC)
Arm/Group Description	Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.		Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m^2 on a weekly schedule; docetaxel 75 mg/m^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m^2 IV on Days 1 and 8 every 21 days
All-Cause Mortality
	Tislelizumab		Investigator Chosen Chemotherapy (ICC)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	233/256 (91.02%)		233/256 (91.02%)
Serious Adverse Events
	Tislelizumab		Investigator Chosen Chemotherapy (ICC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	109/255 (42.75%)		106/240 (44.17%)
Blood and lymphatic system disorders
Agranulocytosis † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Anaemia † 1	1/255 (0.39%)	1	3/240 (1.25%)	9
Febrile neutropenia † 1	0/255 (0.00%)	0	8/240 (3.33%)	9
Iron deficiency anaemia † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Leukopenia † 1	0/255 (0.00%)	0	4/240 (1.67%)	7
Myelosuppression † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Neutropenia † 1	0/255 (0.00%)	0	2/240 (0.83%)	4
Thrombocytopenia † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Cardiac disorders
Acute left ventricular failure † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Autoimmune myocarditis † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Cardiac arrest † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Cardio-respiratory arrest † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Immune-mediated myocarditis † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Myocardial infarction † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Pericardial effusion † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Supraventricular tachycardia † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Endocrine disorders
Adrenocorticotropic hormone deficiency † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Hypothyroidism † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Gastrointestinal disorders
Abdominal distension † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Abdominal pain † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Anal fistula † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Colitis † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Constipation † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Diarrhoea † 1	0/255 (0.00%)	0	8/240 (3.33%)	8
Dysphagia † 1	13/255 (5.10%)	16	4/240 (1.67%)	5
Gastric fistula † 1	0/255 (0.00%)	0	1/240 (0.42%)	2
Gastric haemorrhage † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Gastrointestinal disorder † 1	0/255 (0.00%)	0	2/240 (0.83%)	4
Gastrointestinal haemorrhage † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Intestinal ischaemia † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Intestinal obstruction † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Melaena † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Nausea † 1	0/255 (0.00%)	0	4/240 (1.67%)	6
Odynophagia † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Oesophageal fistula † 1	2/255 (0.78%)	2	1/240 (0.42%)	1
Oesophageal haemorrhage † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Oesophageal obstruction † 1	5/255 (1.96%)	6	1/240 (0.42%)	1
Oesophageal stenosis † 1	3/255 (1.18%)	4	0/240 (0.00%)	0
Oesophagitis † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Oesophagomediastinal fistula † 1	2/255 (0.78%)	2	0/240 (0.00%)	0
Rectal obstruction † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Reflux gastritis † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Stomatitis † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Upper gastrointestinal haemorrhage † 1	4/255 (1.57%)	4	4/240 (1.67%)	4
Vomiting † 1	2/255 (0.78%)	2	3/240 (1.25%)	3
General disorders
Asthenia † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Death † 1	2/255 (0.78%)	2	4/240 (1.67%)	4
Fatigue † 1	2/255 (0.78%)	2	0/240 (0.00%)	0
General physical health deterioration † 1	3/255 (1.18%)	3	4/240 (1.67%)	5
Malaise † 1	0/255 (0.00%)	0	2/240 (0.83%)	2
Multiple organ dysfunction syndrome † 1	3/255 (1.18%)	4	1/240 (0.42%)	1
Oedema peripheral † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Pyrexia † 1	2/255 (0.78%)	2	2/240 (0.83%)	2
Sudden death † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Hepatobiliary disorders
Biliary obstruction † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Immune-mediated hepatitis † 1	1/255 (0.39%)	2	0/240 (0.00%)	0
Jaundice cholestatic † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Immune system disorders
Anaphylactic shock † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Infections and infestations
Abscess neck * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Biliary tract infection * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Bronchitis * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
COVID-19 * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Device related infection * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Infection * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Peritonitis * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Pneumonia * 1	19/255 (7.45%)	24	17/240 (7.08%)	18
Pneumonia aspiration * 1	3/255 (1.18%)	3	1/240 (0.42%)	2
Pneumonia bacterial * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Respiratory tract infection * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Sepsis * 1	2/255 (0.78%)	4	1/240 (0.42%)	1
Septic shock * 1	1/255 (0.39%)	2	4/240 (1.67%)	4
Testicular abscess * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Upper respiratory tract infection * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Urinary tract infection * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Vascular device infection * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Wound infection * 1	0/255 (0.00%)	0	2/240 (0.83%)	3
Injury, poisoning and procedural complications
Thoracic vertebral fracture * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Tracheal haemorrhage * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Tracheostomy malfunction * 1	1/255 (0.39%)	2	0/240 (0.00%)	0
Investigations
Lymphocyte count decreased * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Neutrophil count decreased * 1	0/255 (0.00%)	0	10/240 (4.17%)	14
Platelet count decreased * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
White blood cell count decreased * 1	0/255 (0.00%)	0	8/240 (3.33%)	11
Metabolism and nutrition disorders
Decreased appetite * 1	1/255 (0.39%)	1	6/240 (2.50%)	6
Electrolyte imbalance * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Hypercalcaemia * 1	2/255 (0.78%)	5	0/240 (0.00%)	0
Hypernatraemia * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Hypocalcaemia * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Hypochloraemia * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Hypokalaemia * 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Hyponatraemia * 1	4/255 (1.57%)	7	0/240 (0.00%)	0
Hypophosphataemia * 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Type 1 diabetes mellitus * 1	2/255 (0.78%)	2	0/240 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain † 1	1/255 (0.39%)	2	1/240 (0.42%)	1
Bone pain † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Immune-mediated myositis † 1	2/255 (0.78%)	4	0/240 (0.00%)	0
Muscle spasms † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Muscular weakness † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Musculoskeletal chest pain † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Pathological fracture † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Metastases to heart † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Metastases to liver † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Tumour compression † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Tumour fistulisation † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Tumour haemorrhage † 1	1/255 (0.39%)	1	2/240 (0.83%)	4
Tumour pain † 1	2/255 (0.78%)	2	1/240 (0.42%)	2
Nervous system disorders
Altered state of consciousness † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Ataxia † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Brain oedema † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Cerebral infarction † 1	0/255 (0.00%)	0	1/240 (0.42%)	2
Depressed level of consciousness † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Spinal cord compression † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Syncope † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Psychiatric disorders
Delirium † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Renal and urinary disorders
Nephroangiosclerosis † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula † 1	1/255 (0.39%)	1	4/240 (1.67%)	4
Acute respiratory failure † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Bronchiectasis † 1	1/255 (0.39%)	2	0/240 (0.00%)	0
Cough † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Dyspnoea † 1	3/255 (1.18%)	4	1/240 (0.42%)	2
Haemoptysis † 1	1/255 (0.39%)	1	2/240 (0.83%)	2
Immune-mediated lung disease † 1	3/255 (1.18%)	3	0/240 (0.00%)	0
Lung disorder † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Oesophagobronchial fistula † 1	1/255 (0.39%)	2	1/240 (0.42%)	2
Pleural effusion † 1	3/255 (1.18%)	3	4/240 (1.67%)	4
Pneumonitis † 1	5/255 (1.96%)	5	2/240 (0.83%)	2
Pneumothorax † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Pulmonary arterial hypertension † 1	1/255 (0.39%)	6	0/240 (0.00%)	0
Pulmonary embolism † 1	2/255 (0.78%)	3	1/240 (0.42%)	1
Pulmonary haemorrhage † 1	2/255 (0.78%)	2	0/240 (0.00%)	0
Respiratory failure † 1	1/255 (0.39%)	1	1/240 (0.42%)	1
Tracheal fistula † 1	0/255 (0.00%)	0	1/240 (0.42%)	1
Tracheal stenosis † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Vascular disorders
Hypotension † 1	1/255 (0.39%)	1	0/240 (0.00%)	0
Superior vena cava syndrome † 1	1/255 (0.39%)	2	0/240 (0.00%)	0
1 Term from vocabulary, MedDRA (25.0); † Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	Tislelizumab		Investigator Chosen Chemotherapy (ICC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	232/255 (90.98%)		231/240 (96.25%)
Blood and lymphatic system disorders
Anaemia † 1	80/255 (31.37%)	139	109/240 (45.42%)	192
Leukopenia † 1	9/255 (3.53%)	19	29/240 (12.08%)	57
Neutropenia † 1	2/255 (0.78%)	11	30/240 (12.50%)	56
Thrombocytopenia † 1	5/255 (1.96%)	7	10/240 (4.17%)	13
Endocrine disorders
Hyperthyroidism † 1	8/255 (3.14%)	8	1/240 (0.42%)	1
Hypothyroidism † 1	30/255 (11.76%)	37	1/240 (0.42%)	1
Gastrointestinal disorders
Abdominal distension † 1	9/255 (3.53%)	10	8/240 (3.33%)	9
Abdominal pain † 1	17/255 (6.67%)	20	22/240 (9.17%)	27
Abdominal pain upper † 1	9/255 (3.53%)	12	16/240 (6.67%)	18
Constipation † 1	41/255 (16.08%)	46	45/240 (18.75%)	60
Diarrhoea † 1	32/255 (12.55%)	47	75/240 (31.25%)	134
Dysphagia † 1	22/255 (8.63%)	23	17/240 (7.08%)	22
Gastrooesophageal reflux disease † 1	14/255 (5.49%)	16	12/240 (5.00%)	13
Nausea † 1	37/255 (14.51%)	43	72/240 (30.00%)	123
Stomatitis † 1	9/255 (3.53%)	10	14/240 (5.83%)	21
Vomiting † 1	27/255 (10.59%)	33	48/240 (20.00%)	88
General disorders
Asthenia * 1	29/255 (11.37%)	41	36/240 (15.00%)	63
Fatigue * 1	33/255 (12.94%)	43	42/240 (17.50%)	68
Malaise * 1	16/255 (6.27%)	18	35/240 (14.58%)	54
Oedema peripheral * 1	9/255 (3.53%)	12	11/240 (4.58%)	13
Pyrexia * 1	40/255 (15.69%)	56	33/240 (13.75%)	42
Infections and infestations
Nasopharyngitis * 1	9/255 (3.53%)	14	6/240 (2.50%)	7
Pneumonia * 1	28/255 (10.98%)	31	14/240 (5.83%)	17
Upper respiratory tract infection * 1	8/255 (3.14%)	11	11/240 (4.58%)	11
Investigations
Alanine aminotransferase increased * 1	33/255 (12.94%)	49	19/240 (7.92%)	22
Aspartate aminotransferase increased * 1	37/255 (14.51%)	55	11/240 (4.58%)	13
Blood alkaline phosphatase increased * 1	17/255 (6.67%)	26	5/240 (2.08%)	10
Blood bilirubin increased * 1	9/255 (3.53%)	16	6/240 (2.50%)	11
Blood creatine phosphokinase MB increased * 1	11/255 (4.31%)	14	1/240 (0.42%)	1
Blood creatine phosphokinase increased * 1	10/255 (3.92%)	15	0/240 (0.00%)	0
C-reactive protein increased * 1	8/255 (3.14%)	8	2/240 (0.83%)	2
Gamma-glutamyltransferase increased * 1	14/255 (5.49%)	23	8/240 (3.33%)	10
Lymphocyte count decreased * 1	12/255 (4.71%)	21	22/240 (9.17%)	36
Neutrophil count decreased * 1	6/255 (2.35%)	19	88/240 (36.67%)	202
Platelet count decreased * 1	14/255 (5.49%)	23	16/240 (6.67%)	20
Weight decreased * 1	62/255 (24.31%)	101	45/240 (18.75%)	55
White blood cell count decreased * 1	11/255 (4.31%)	25	95/240 (39.58%)	227
White blood cell count increased * 1	12/255 (4.71%)	17	6/240 (2.50%)	8
Metabolism and nutrition disorders
Decreased appetite * 1	42/255 (16.47%)	53	80/240 (33.33%)	102
Hyperglycaemia * 1	17/255 (6.67%)	35	8/240 (3.33%)	8
Hyperkalaemia * 1	8/255 (3.14%)	13	2/240 (0.83%)	3
Hyperuricaemia * 1	6/255 (2.35%)	13	11/240 (4.58%)	19
Hypoalbuminaemia * 1	36/255 (14.12%)	51	30/240 (12.50%)	44
Hypocalcaemia * 1	8/255 (3.14%)	11	11/240 (4.58%)	17
Hypochloraemia * 1	6/255 (2.35%)	10	10/240 (4.17%)	13
Hypoglycaemia * 1	8/255 (3.14%)	11	3/240 (1.25%)	4
Hypokalaemia * 1	22/255 (8.63%)	23	22/240 (9.17%)	42
Hyponatraemia * 1	31/255 (12.16%)	56	33/240 (13.75%)	45
Hypoproteinaemia * 1	13/255 (5.10%)	14	8/240 (3.33%)	10
Musculoskeletal and connective tissue disorders
Arthralgia † 1	22/255 (8.63%)	25	18/240 (7.50%)	24
Back pain † 1	28/255 (10.98%)	32	17/240 (7.08%)	27
Myalgia † 1	8/255 (3.14%)	9	14/240 (5.83%)	26
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain † 1	10/255 (3.92%)	12	3/240 (1.25%)	4
Nervous system disorders
Dizziness † 1	11/255 (4.31%)	13	19/240 (7.92%)	26
Peripheral sensory neuropathy † 1	2/255 (0.78%)	3	23/240 (9.58%)	36
Psychiatric disorders
Insomnia † 1	21/255 (8.24%)	24	17/240 (7.08%)	23
Respiratory, thoracic and mediastinal disorders
Cough † 1	44/255 (17.25%)	56	28/240 (11.67%)	30
Dysphonia † 1	8/255 (3.14%)	8	2/240 (0.83%)	2
Dyspnoea † 1	25/255 (9.80%)	29	19/240 (7.92%)	23
Haemoptysis † 1	10/255 (3.92%)	11	5/240 (2.08%)	7
Pneumonitis † 1	10/255 (3.92%)	12	2/240 (0.83%)	2
Productive cough † 1	18/255 (7.06%)	21	18/240 (7.50%)	19
Skin and subcutaneous tissue disorders
Alopecia † 1	1/255 (0.39%)	1	42/240 (17.50%)	46
Pruritus † 1	25/255 (9.80%)	34	11/240 (4.58%)	13
Rash † 1	23/255 (9.02%)	31	10/240 (4.17%)	10
Vascular disorders
Hypertension † 1	13/255 (5.10%)	32	6/240 (2.50%)	15
Hypotension † 1	10/255 (3.92%)	14	6/240 (2.50%)	8
1 Term from vocabulary, MedDRA (25.0); † Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

The impact on treatment was considered very limited due to the small number of patients remaining on treatment, the short COVID-19 restriction period (in Asia), and limited restrictions for healthcare visits (in Europe/North America).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.

Results Point of Contact

• Name/Title: Study Director
• Organization: BeiGene
• Phone: 1-877-828-5568
• EMail: clinicaltrials@beigene.com

Publications of Results:

Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20. Erratum In: J Clin Oncol. 2024 Feb 1;42(4):486.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Van Cutsem E, Kato K, Ajani J, Shen L, Xia T, Ding N, Zhan L, Barnes G, Kim SB. Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life. ESMO Open. 2022 Aug;7(4):100517. doi: 10.1016/j.esmoop.2022.100517. Epub 2022 Jul 1.

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT03430843
• Other Study ID Numbers: BGB-A317-302; 2017-003699-30 ( EudraCT Number ); CTR20171026 ( Registry Identifier: ChinaDrugTrials )
• First Submitted: January 29, 2018
• First Posted: February 13, 2018
• Results First Submitted: November 10, 2023
• Results First Posted: December 29, 2023
• Last Update Posted: December 29, 2023