This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Administered intravenously
Administered intravenously
Administered intravenously
Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment
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
Time frame: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)
Objective Response Rate (ORR) by IRC Assessment
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.
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
Duration of Response (DOR) by IRC Assessment
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
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
PFS by Investigator Assessment
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
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
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Administered intravenously
Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
...and 37 more locations
ORR by Investigator Assessment
ORR is defined as the percentage of participants with CR or PR, as assessed by the investigator using RECIST v1.1
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
DOR by Investigator Assessment
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
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)
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.
Time frame: Baseline to Cycle 5 (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
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.
Time frame: Baseline to Cycle 5 (each cycle is 21 days)
Number of Participants With Adverse Events
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
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)
PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression
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
Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)