Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
EXCLUSION CRITERIA
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Small Cell Lung Cancer
Age (in years)
18+
Phase
PHASE3
Participants Needed
457
Est. Completion Date
Dec 29, 2023
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT04005716
Study Number
BGB-A317-312
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