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Phase 3 N=457 Randomized Double-blind Treatment

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Cancer

Enrolled (actual)
457
Serious AEs
36.0%
Results posted
Feb 2025
Primary outcome: Primary: Overall Survival (OS) — 15.5; 13.5 Months — p=0.0040

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Tislelizumab (Drug); Cisplatin (Drug); Carboplatin (Drug); Etoposide (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
BeiGene
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival (OS)
15.5; 13.5 0.0040 sig
SECONDARY
Progression Free Survival (PFS)
4.7; 4.3 <0.0001 sig
SECONDARY
Overall Response Rate (ORR)
68.3; 61.7
SECONDARY
Disease Control Rate (DCR)
88.5; 88.3
SECONDARY
Clinical Benefit Rate (CBR)
69.2; 65.2
SECONDARY
Duration of Response (DOR)
4.3; 3.7
SECONDARY
Number of Participants With Adverse Events
226; 228; 94; 70
SECONDARY
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.
8.9; 4.5; 11.3; 4.2; 0.6; 0.4
SECONDARY
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
-19.5; -16.0; -18.6; -16.7; -2.5; -3.1
SECONDARY
Time to Deterioration (TTD)
NA; NA; NA; NA; NA; NA

Summary

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).

Eligibility Criteria

Key Inclusion Criteria

  • Age≥18 years old, male or female, signed Informed Consent Form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed ES-SCLC
  • No prior systemic treatment for ES-SCLC
  • Adequate hematologic and end organ function

Key Exclusion Criteria

  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
  • Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
  • Was administered a live vaccine ≤ 4 weeks before randomization;
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;
  • With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
  • Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection;
  • Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;
  • Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;
  • Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04005716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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