18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival (OS)Primary· 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.
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.
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
15.5
13.5 – 17.1
Arm B: Placebo + Chemotherapy
13.5
12.1 – 14.9
Progression Free Survival (PFS)Secondary· 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.
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.
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
4.7
4.3 – 5.5
Arm B: Placebo + Chemotherapy
4.3
4.2 – 4.4
Overall Response Rate (ORR)Secondary· 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.
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 lesio
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
68.3
61.8 – 74.3
Arm B: Placebo + Chemotherapy
61.7
55.1 – 68.0
Disease Control Rate (DCR)Secondary· 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.
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.
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
88.5
83.7 – 92.4
Arm B: Placebo + Chemotherapy
88.3
83.4 – 92.1
Clinical Benefit Rate (CBR)Secondary· 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.
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.
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
69.2
62.7 – 75.1
Arm B: Placebo + Chemotherapy
65.2
58.7 – 71.4
Duration of Response (DOR)Secondary· 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.
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.
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
4.3
4.1 – 5.6
Arm B: Placebo + Chemotherapy
3.7
3.0 – 4.1
Number of Participants With Adverse EventsSecondary· 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.
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.
TEAEs
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
226
Arm B: Placebo + Chemotherapy
228
SAEs
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
94
Arm B: Placebo + Chemotherapy
70
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.Secondary· Baseline to Cycles 4 and 6 ( Each cycle was 21 days)
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
Global Health Status/Quality of Life (Cycle 4)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
8.9
± 22.79
Arm B: Placebo + Chemotherapy
4.5
± 19.46
Global Health Status/Quality of Life (Cycle 6)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
11.3
± 21.30
Arm B: Placebo + Chemotherapy
4.2
± 19.04
Physical Functioning (Cycle 4)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
0.6
± 14.82
Arm B: Placebo + Chemotherapy
0.4
± 14.57
Physical Functioning (Cycle 6)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
1.9
± 15.18
Arm B: Placebo + Chemotherapy
1.8
± 12.36
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom ScoresSecondary· Baseline to Cycles 4 and 6 ( Each cycle was 21 days)
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.
Coughing (Cycle 4)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
-19.5
± 26.58
Arm B: Placebo + Chemotherapy
-16.0
± 22.85
Coughing (Cycle 6)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
-18.6
± 27.86
Arm B: Placebo + Chemotherapy
-16.7
± 25.08
Dysphagia (Cycle 4)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
-2.5
± 12.12
Arm B: Placebo + Chemotherapy
-3.1
± 14.72
Dysphagia (Cycle 6)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
-2.9
± 11.47
Arm B: Placebo + Chemotherapy
-3.5
± 15.23
Chest Pain (Cycle 4)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
-7.5
± 22.65
Arm B: Placebo + Chemotherapy
-5.9
± 20.97
Chest Pain (Cycle 6)
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
-7.0
± 25.34
Arm B: Placebo + Chemotherapy
-6.9
± 21.51
Time to Deterioration (TTD)Secondary· 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.
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.
QLQ-C30: Physical Functioning
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
NA
20.5 – NA
Arm B: Placebo + Chemotherapy
NA
10.3 – NA
QLQ-LC13: Coughing
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
NA
NA – NA
Arm B: Placebo + Chemotherapy
NA
NA – NA
QLQ-LC13: Chest Pain
Group
Value
95% CI
Arm A: Tislelizumab + Chemotherapy
NA
NA – NA
Arm B: Placebo + Chemotherapy
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from 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..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
· Phase 2
· not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
· Phase 3
· not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure
· Phase 2
· recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
· Phase 2
· not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
· Phase 2
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 28 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04005716.