Probiotics plus intensified hyperfractionated chemoradiation with adebrelimab maintenance for limited-stage small cell lung cancer

A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)

This trial tests whether adding probiotics and an intensified hyperfractionated radiotherapy plan to chemo, followed by adebrelimab maintenance, helps people with limited-stage small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06943235 on ClinicalTrials.gov

What this trial studies

This phase 2, single-center study enrolls adults with limited-stage small cell lung cancer (ECOG 0-1) who have received no more than two rounds of chemotherapy (with or without immunotherapy). Participants receive concurrent hyperfractionated radiotherapy with a simultaneous integrated boost together with chemotherapy and daily probiotics, followed by adebrelimab monoclonal antibody as maintenance immunotherapy. The study will track tumor control, progression-free and overall survival, and treatment-related toxicities to characterize safety and activity. All treatment and follow-up are conducted at Fudan University Shanghai Cancer Center.

Who should consider this trial

Good fit: Ideal candidates are adults (18–80) with pathologically confirmed limited-stage small cell lung cancer, ECOG performance status 0–1, expected survival >3 months, and who have had no more than two prior chemotherapy (±immunotherapy) cycles and no prior chest radiotherapy.

Not a fit: Patients with progressive disease after two induction treatments, severe lung disease (e.g., emphysema, interstitial changes, COPD), resting oxygen <93%, prior chest radiotherapy, or recent other malignancies are unlikely to benefit or be ineligible.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control and survival for patients with limited-stage small cell lung cancer while maintaining acceptable side effects.

How similar studies have performed: Maintenance immunotherapy after chemoradiation (for example the ADRIATIC results) has shown promise, but combining intensified hyperfractionated radiotherapy with probiotics and adebrelimab is a novel approach that has not been widely tested.

Eligibility criteria

Inclusion Criteria:

1. Sign written informed consent before implementing any experimental procedures;
2. Age range: 18-80 years old;
3. Pathological diagnosis of small cell lung cancer;
4. Limited stage;
5. ECOG PS 0-1；
6. Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy;
7. Expected survival time\>3 months;

Exclusion Criteria:

1. Progress after 2 induction treatments;
2. Severe emphysema, interstitial changes in the lungs, COPD patients;
3. Resting blood oxygen\<93;
4. Have a history of other malignant tumors and have received chemotherapy in the past 3 years;
5. History of chest radiotherapy;

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xingwen Fan

Conditions Limited Stage Small Cell Lung Cancer