Adebrelimab plus chemotherapy with concurrent low-dose radiotherapy for extensive-stage small cell lung cancer

Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)

This trial tests whether adding the immunotherapy adebrelimab to standard chemotherapy together with low-dose radiotherapy helps adults with extensive-stage small cell lung cancer live longer or respond better to treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: Adebrelimab, Chemotherapy
• Locations: 1 site (Sichuan)
• Trial ID: NCT06610734 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized phase II trial enrolling adults with newly diagnosed extensive-stage small cell lung cancer and good performance status. Participants are randomized to receive adebrelimab in combination with platinum-based chemotherapy and concurrent low-dose radiotherapy versus a control regimen per protocol. Treatment includes induction chemo with concurrent LDRT and scheduled doses of adebrelimab, with safety monitoring throughout and follow-up for response and survival. Key outcomes include tumor response, progression-free and overall survival, and treatment tolerability.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed extensive-stage SCLC, ECOG 0–1, treatment‑naive for extensive disease, and expected survival ≥8 weeks are the intended participants.

Not a fit: Patients with mixed small cell/non-small cell histology, poor performance status (ECOG ≥2), prior systemic therapy for extensive SCLC, recent major surgery, or inability to receive radiotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase response rates and extend survival compared with chemotherapy alone.

How similar studies have performed: Previous phase III trials adding immune checkpoint inhibitors such as atezolizumab or durvalumab to chemotherapy showed modest survival benefits in extensive-stage SCLC, and combining radiotherapy with immunotherapy is an active area with early supportive signals.

Eligibility criteria

Inclusion Criteria:

* Participants aged 18 to 75 years, regardless of gender;
* ECOG Performance Status (PS) score of 0-1;
* Expected survival duration of no less than 8 weeks;
* Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);
* Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.

Exclusion Criteria:

* Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;
* Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);
* Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;
* Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;
* History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;
* Any previous T-cell co-stimulation or immune checkpoint therapies administered;
* Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\"

Where this trial is running

Sichuan

• West China Hospital of Sichuan University — Sichuan, China (Recruiting)

Study contacts

• Principal investigator: You Lu — West China Hospital
• Study coordinator: You Lu

Conditions Small Cell Lung Cancer Extensive Stage; SCLC; Adebrelimab; LDRT