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Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04005716•BeiGene

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (50)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital