RecruitingPhase 2NCT06177925

A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC

A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

62 participants

Start Date

Dec 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of adebrelimab (an immunotherapy drug) with chemotherapy and radiation therapy for patients with extensive-stage small cell lung cancer (SCLC) that has spread to only a few sites (called oligometastatic disease — 5 or fewer lesions in 3 or fewer organs), to see if this aggressive combined approach improves survival. **You may be eligible if...** - You are between 18 and 75 years old with confirmed extensive-stage small cell lung cancer - Your cancer has spread to 5 or fewer lesions in 3 or fewer organs (oligometastatic) - You have not previously received chemotherapy, radiation, or immunotherapy for this cancer - You have a good performance status (ECOG 0-1) and expected survival of at least 3 months **You may NOT be eligible if...** - Your cancer has spread extensively beyond 5 lesions or to more than 3 organs - You have cancer in the fluid around the brain (leptomeningeal disease) - You have uncontrolled fluid around the lungs or heart - You have had another cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.

DRUGCarboplatin/Cisplatin

Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

DRUGEtoposide

Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

RADIATIONRadiation therapy

IMRT for thoracic of 45--55Gy in 15-22 fractions,SBRT for metastases during the concurrent chemoradiotherapy phase


Locations(1)

Nanfang Hospital, Southern Medical University

Guangzhou, China

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NCT06177925


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