Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer (NCT NCT03663205)

Last Updated: 2025-02-04

Results Overview

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

334 participants

Primary outcome timeframe

Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)

Results posted on

2025-02-04

Participant Flow

This study was conducted at 47 study centers in China.

Participant milestones

Participant milestones
Measure	Tislelizumab + Platinum + Pemetrexed Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Overall Study STARTED	223	111
Overall Study Randomized But Not Treated	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	223	111

Reasons for withdrawal

Reasons for withdrawal
Measure	Tislelizumab + Platinum + Pemetrexed Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Overall Study Death	144	69
Overall Study Sponsor decision	53	19
Overall Study Withdrawal by Subject	8	11
Overall Study Lost to Follow-up	7	9
Overall Study Transferred to long term extension study	11	3

Baseline Characteristics

PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tislelizumab + Platinum + Pemetrexed n=223 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Total n=334 Participants Total of all reporting groups
Age, Continuous	61.0 Years n=5 Participants	62.0 Years n=7 Participants	61.0 Years n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	32 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	79 Participants n=7 Participants	247 Participants n=5 Participants
Race/Ethnicity, Customized Asian	223 Participants n=5 Participants	111 Participants n=7 Participants	334 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	223 Participants n=5 Participants	111 Participants n=7 Participants	334 Participants n=5 Participants
Smoking Status Never	76 Participants n=5 Participants	45 Participants n=7 Participants	121 Participants n=5 Participants
Smoking Status Current	32 Participants n=5 Participants	13 Participants n=7 Participants	45 Participants n=5 Participants
Smoking Status Former	115 Participants n=5 Participants	53 Participants n=7 Participants	168 Participants n=5 Participants
PD-L1 Expression in Tumor Cells <1%	91 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	48 Participants n=7 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	139 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.
PD-L1 Expression in Tumor Cells 1%-49%	53 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	27 Participants n=7 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	80 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.
PD-L1 Expression in Tumor Cells ≥ 50%	74 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	36 Participants n=7 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	110 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.
PD-L1 Expression in Tumor Cells Unevaluable	5 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	0 Participants n=7 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.	5 Participants n=5 Participants • PD-L1 unevaluable refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample.

PRIMARY outcome

Timeframe: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)

Population: ITT analysis set included all randomized participants

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=223 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment	9.7 Months Interval 7.72 to 11.53	7.6 Months Interval 5.55 to 8.02

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the IRC using RECIST v1.1.

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=223 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Objective Response Rate (ORR) by IRC Assessment	57.8 Percentage of participants Interval 51.1 to 64.4	36.9 Percentage of participants Interval 28.0 to 46.6

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants

DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the IRC using RECIST v1.1 in participants with documented objective responses

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=129 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=41 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Duration of Response (DOR) by IRC Assessment	10.6 Months Interval 8.38 to 17.64	7.0 Months Interval 4.99 to 10.61

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants

OS is defined as the time from randomization until the date of death due to any cause

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=223 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Overall Survival (OS)	21.4 Months Interval 17.91 to 25.4	20.1 Months Interval 14.88 to 28.12

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants

PFS is defined as the time from randomization until first objectively documented disease progression, or death from any cause, whichever occurs first, as assessed by the investigator per RECIST v1.1

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=223 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
PFS by Investigator Assessment	9.7 Months Interval 7.66 to 11.7	5.6 Months Interval 4.8 to 7.66

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants

ORR is defined as the percentage of participants with CR or PR, as assessed by the investigator using RECIST v1.1

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=223 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
ORR by Investigator Assessment	57.4 Percentage of participants Interval 50.6 to 64.0	36.0 Percentage of participants Interval 27.1 to 45.7

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants

DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1 in participants with documented objective responses

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=128 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=40 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
DOR by Investigator Assessment	14.5 Months Interval 9.72 to 18.66	8.4 Months Interval 5.55 to 10.38

SECONDARY outcome

Timeframe: Baseline to Cycle 5 (each cycle is 21 days)

Population: Health-related quality of life (HRQoL) analysis set included all randomized participants who received at least 1 dose of study drug and completed at least 1 HRQoL assessment

Change from baseline in EORTC QLQ-CL13 scores for coughing, dyspnea, and chest pain . The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes 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. A lower score indicates an improvement in symptoms.

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=222 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=110 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Dyspnea	-1.4 Score on a scale Interval -3.5 to 0.6	-0.3 Score on a scale Interval -3.2 to 2.6
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Coughing	-13.0 Score on a scale Interval -16.6 to -9.4	-10.8 Score on a scale Interval -15.7 to -5.9
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Chest Pain	-7.4 Score on a scale Interval -10.4 to -4.5	-4.2 Score on a scale Interval -8.3 to -0.2

SECONDARY outcome

Timeframe: Baseline to Cycle 5 (each cycle is 21 days)

Population: HRQoL analysis set included all randomized participants who received at least 1 dose of study drug and completed at least 1 HRQoL assessment

Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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.

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=222 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=110 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status	0.9 Score on a scale Interval -2.0 to 3.8	-3.0 Score on a scale Interval -7.3 to 1.2

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: Safety analysis set included all randomized participants who received at least one dose of study treatment

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, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=222 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=110 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Number of Participants With Adverse Events At least one TEAE	222 Participants	109 Participants
Number of Participants With Adverse Events At least one SAE	99 Participants	25 Participants

SECONDARY outcome

Timeframe: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

Population: ITT analysis set included all randomized participants; participants evaluable for PD-L expression were included

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the IRC per RECIST v1.1, based on PD-L1 expression in tumor cells

Outcome measures

Outcome measures
Measure	Tislelizumab + Platinum + Pemetrexed n=218 Participants Tislelizumab 200 mg administered IV once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)	Platinum + Pemetrexed n=111 Participants Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression <1% of tumor cells	7.6 Months Interval 5.0 to 9.7	7.6 Months Interval 4.3 to 7.9
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression 1% to 49% of tumor cells	9.7 Months Interval 6.9 to 11.7	9.7 Months Interval 5.6 to 16.8
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression ≥ 50% of tumor cells	17.2 Months Interval 11.5 to 31.4	4.6 Months Interval 3.5 to 9.7

Adverse Events

Tislelizumab + Platinum + Pemetrexed

Serious events: 99 serious events

Other events: 222 other events

Deaths: 144 deaths

Platinum + Pemetrexed Alone

Serious events: 25 serious events

Other events: 109 other events

Deaths: 69 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: 1-877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER