RecruitingPhase 2NCT07141264

Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy

A Single-Arm, Exploratory Study of Adebrelimab Combined With Etoposide Capsules as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

Sponsor

Tang-Du Hospital

Enrollment

32 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

SCLC,Extensive Stage

Summary

This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether continuing two drugs — adebrelimab (an immunotherapy) and etoposide (a chemotherapy pill) — as maintenance therapy helps people with advanced small cell lung cancer live longer after their initial treatment. Participants must have already responded to initial treatment before joining. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with extensive-stage small cell lung cancer - You completed 4–6 rounds of platinum-based chemotherapy plus adebrelimab without disease progression - Your performance status (ability to carry out daily activities) is reasonably good - Your blood, kidney, and liver function meet required levels **You may NOT be eligible if...** - You have limited-stage small cell lung cancer - You have already received anti-blood vessel (anti-angiogenic) therapy - You have trouble swallowing or have conditions affecting oral medication absorption - You have an active autoimmune disease or serious heart, lung, or liver conditions - You have active brain metastases at the time of enrollment - You had severe immune-related side effects during your initial treatment 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAdebrelimab combined with Etoposide Capsules

Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Etoposide Capsules is given orally at a dosage of 50mg or 25mg daily, day 1 to 14 of a 21-day cycle. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.