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

Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study

This trial will test whether adding tislelizumab to first-line platinum-etoposide chemotherapy followed by planned chest radiotherapy helps people with newly diagnosed extensive-stage small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anhui Provincial Cancer Hospital (Academic / other)
• Drugs / interventions: Tislelizumab, chemotherapy
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06838208 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with newly diagnosed, treatment-naïve extensive-stage small cell lung cancer, ECOG 0–1, adequate organ function, and at least one chest lesion suitable for 15 Gy/5 fraction radiotherapy are ideal candidates.

Not a fit: Patients with uncontrolled or untreated brain metastases, active or relapsing autoimmune disease, prior PD-1/PD-L1/CTLA-4 therapy, recent live vaccination, or those requiring systemic corticosteroids or other immunosuppression are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could increase tumor control and extend progression-free and overall survival compared with chemotherapy alone for patients fit enough to receive combined therapy.

How similar studies have performed: Other first-line trials adding PD-1/PD-L1 inhibitors to platinum-etoposide (for example, atezolizumab and durvalumab trials) have shown survival benefits, so combining tislelizumab with chemo builds on that evidence, though the specific relayed radiotherapy schedule is less well established.

Eligibility criteria

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 this trial is running

Hefei, Anhui

• Anhui Cancer Hospital — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Shuanghu Yuan, PhD

Conditions Extensive-stage Small Cell Lung Cancer