Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07141264

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
Tang-Du Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAdebrelimab combined with Etoposide CapsulesEach 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.

Timeline

Start date
2025-08-25
Primary completion
2026-12-30
Completion
2027-12-30
First posted
2025-08-26
Last updated
2025-12-30

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07141264. Inclusion in this directory is not an endorsement.