NCT06672133

Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC

Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC: a Randomized Controlled Phase III Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Jinming Yu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I.To compare investigator-assessed progression free survival (PFS) between adebrelimab plus radiotherapy and adebrelimab alone. II.To compare overall survival (OS) between adebrelimab plus radiotherapy and adebrelimab alone. SECONDARY OBJECTIVES: I.To assess the ORR (objective response rate)、DoR (Duration of response) 、DCR(Disease control rate) toxicity between the adebrelimab plus radiotherapy arm and the adebrelimab arm. II.To assess six months and one-year PFS rate、one-year and two-year OS rate between the adebrelimab plus radiotherapy arm and the adebrelimab arm. III.To assess the safety and tolerability. EXPLORATORY OBJECTIVE: I.To detect biomarkers associated with efficacy OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive adebrelimab IV over 30 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only. ARM II: Patients receive adebrelimab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT)、magnetic resonance imaging (MRI) or positron emission tomography and computed tomography (PET/CT) scan, throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Conditions

• Extensive Stage Lung Small Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab	Given：IV
RADIATION	Radiation Therapy	Undergo radiation therapy

Timeline

• Start date: 2024-12-01
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2024-11-04
• Last updated: 2024-11-05