An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Administered intravenously as described
Administered intravenously as described
Administered intravenously as described
Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first
Time frame: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)
PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first
Time frame: Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 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 28APR2023 (up to approximately 4 years and 9 months)
Objective Response Rate (ORR) by IRC Assessment
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the IRC using RECIST v1.1.
Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
ORR by Investigator Assessment
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the investigator using RECIST v1.1.
Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
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Administered intravenously as described
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
...and 33 more locations
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 assessed by the IRC using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.
Time frame: Through study completion data cut-off date of 28APR2023 (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 assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.
Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
PFS by Investigator Assessment
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first
Time frame: Through study completion data cut-off date of 28APR2023 (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 disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first, based on PD-L1 expression in tumor cells
Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)
Least squares mean change from baseline in EORTC QLQ-CL13 scores for chest pain, coughing, and dyspnea between tislelizumab arms and paclitaxel + carboplatin arm. 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
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status
Least squares mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. 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: From first dose to 30 days after the last dose (up to approximately 4 years and 9 months)