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NOT YET RECRUITING
NCT07909863
PHASE2

Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This is a phase II study evaluating a novel combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial induction phase with the drug Adebrelimab plus standard chemotherapy and low-dose radiotherapy, followed by an Adebrelimab maintenance phase. The primary objective is to assess the efficacy of this approach in prolonging overall survival (OS) and to evaluate its safety in approximately 25 patients.

Official title: A Single-arm, Single-center, Phase II Clinical Study of Low-dose Radiotherapy Combined With Adebrelimab and Chemotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-11-15

Completion Date

2028-09-01

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Adebrelimab + Chemotherapy + Radiotherapy

Participants receive a two-phase treatment regimen. Induction (4 fixed cycles, q3w): Adebrelimab (1200 mg IV over 60 minutes, Day 1) followed by investigator's choice of standard platinum-etoposide chemotherapy (EC regimen: Carboplatin AUC=5 on Day 1 + Etoposide 100 mg/m² on Days 1-3; or EP regimen: Cisplatin 75 mg/m² on Day 1 + Etoposide 100 mg/m² on Days 1-3). Concurrent hypofractionated radiotherapy to the primary lung lesion (5 Gy per fraction for 5 fractions) is administered during Cycle 1 or Cycle 2. Maintenance: Patients without disease progression after 4 cycles continue Adebrelimab (1200 mg IV, q3w) for up to 2 years, until disease progression (per RECIST v1.1), unacceptable grade ≥3 immune-related toxicity, or withdrawal of consent.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China