This Phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (Arm A), compared to placebo combined with either cisplatin or carboplatin and etoposide (Arm B), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
457
200 mg administered intravenously on Day 1 of each 21-day cycle
75 mg/m² was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of two hours. Treatment with cisplatin was discontinued starting in Cycle 5 and beyond.
An area under the curve (AUC) of 5 mg/mL/min was administered intravenously on Day 1 of each 21-day cycle, infused over a duration of 15 to 60 minutes. Treatment with carboplatin was discontinued starting in Cycle 5 and beyond.
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Time frame: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
Progression Free Survival (PFS)
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS. 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 any new lesions.
Time frame: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
Overall Response Rate (ORR)
Orr is defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized patients with measurable disease at baseline. Complete Response (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. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions with 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.
Time frame: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
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100 mg/m² was administered intravenously from Day 1 to Day 3 of each 21-day cycle, infused over a duration of 60 minutes. Treatment with etoposide was discontinued starting in Cycle 5 and beyond.
200 mg was administered intravenously on Day 1 of each 21-day cycle to match tislelizumab.
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
China Japan Friendship Hospital
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
Peking University International Hospital
Beijing, Beijing Municipality, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
...and 40 more locations
Disease Control Rate (DCR)
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1. Stable Disease: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions.
Time frame: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
Clinical Benefit Rate (CBR)
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) per RECIST v1.1.
Time frame: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
Duration of Response (DOR)
Defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the investigator per RECIST v1.1, or death from any cause, whichever comes first. Median DOR was estimated using Kaplan-Meier methodology.
Time frame: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
Number of Participants With Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: From the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score.
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 2 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 and functional scales indicate better quality of life.
Time frame: Baseline to Cycles 4 and 6 ( Each cycle was 21 days)
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Change from baseline in EORTC QLQ-CL13 scores for coughing, dysphagia, 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 Cycles 4 and 6 ( Each cycle was 21 days)
Time to Deterioration (TTD)
Time to deterioration is defined as the time from randomization to the first confirmed worsening score or death. Clinically meaningful deterioration is defined as a ≥10-point decrease from baseline in QLQ-C30 physical functioning and a ≥10-point increase in QLQ-LC13 coughing and chest pain scores. If a participant did not have an event (death or deterioration), they were censored at their last clinic visit at which corresponding score was measured. Median TTD was estimated using Kaplan-Meier methodology.
Time frame: From randomization to the primary completion data cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.