Study of Platinum Plus Etoposide With or Without BGB-A317 in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to compare the efficacy of tislelizumab + cisplatin or carboplatin + etoposide (Arm A) and placebo + cisplatin or carboplatin + etoposide (Arm B) as first-line treatment in approximately 455 participants who have previously untreated extensive-stage small cell lung cancer (ES-SCLC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Carboplatin; Cisplatin; Etoposide; Etoposide phosphate

Criteria

Key Inclusion Criteria:

1. Age≥18 years old, male or female, signed Informed Consent Form (ICF).

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

3. Histologically or cytologically confirmed ES-SCLC

4. No prior systemic treatment for ES-SCLC

5. Adequate hematologic and end organ function

Key Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;

2. 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;

3. Was administered a live vaccine ≤ 4 weeks before randomization;

4. Active autoimmune diseases or history of autoimmune diseases that may relapse

5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization;

6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;

7. 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;

8. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (HCV), or a known history of HIV infection;

9. Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization;

10. Clinically significant pericardial effusion, or Clinically uncontrolled pleural effusion

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