Tislelizumab with platinum-etoposide chemotherapy and follow-up chest radiotherapy for extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial combining the anti–PD-1 antibody tislelizumab with standard first-line chemotherapy (carboplatin or cisplatin plus etoposide) and relayed radiotherapy to chest lesions. Participants must have histologically or cytologically confirmed extensive-stage SCLC, be treatment-naïve, and have ECOG performance status 0–1 and at least one chest lesion suitable for the planned radiation. The regimen is given systemically with radiotherapy delivered to eligible chest sites after initial cycles of chemoimmunotherapy. Key safety exclusions include prior checkpoint inhibitor therapy, active or uncontrolled brain metastases, active autoimmune disease, recent live vaccines, or need for systemic immunosuppression. The study will monitor tumor responses, survival outcomes, and treatment-related adverse events.

Why it matters

Who can join: the full rules

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. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
6. 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 treatment;
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 treatment;
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 treatment, including but not limited to tuberculosis infection;
8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;

Where it's running

• Anhui Cancer Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Shuanghu Yuan, PhD
• Email: yuanshuanghu@sina.com
• Phone: 0551-62894008

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.