For Healthcare Professionals

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

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About the study

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)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

EXCLUSION CRITERIA

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.


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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’s details


Contition

Small Cell Lung Cancer

Age (in years)

18+

Phase

Phase 3

Participants needed

457

Est. Completion Date

Nov 30, 2024

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT04005716

Study number

BGB-A317-312

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