Actively Recruiting
Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Led by Sichuan University · Updated on 2026-02-09
202
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sichuan University
Lead Sponsor
S
Shanghai Shengdi Pharmaceutical Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Adebrelimab with chemotherapy and concurrent low-dose radiotherapy (LDRT) for treating extensive-stage small cell lung cancer (SCLC). This Phase II randomized controlled trial aims to understand if adding LDRT to Adebrelimab plus chemotherapy improves treatment outcomes in patients newly diagnosed with this advanced form of lung cancer. The study is sponsored by Sichuan University and focuses on comparing overall survival and other treatment effects between groups. Participants are randomly assigned to one of two groups: one receives Adebrelimab combined with chemotherapy and synchronous low-dose radiotherapy, while the other receives Adebrelimab combined with chemotherapy alone. The treatments are given following a set schedule during the first-line and second-line therapy phases. Researchers monitor responses and side effects throughout these treatment periods to assess the combination strategy. During the study, participants will undergo regular assessments including survival tracking, disease progression checks, response evaluations, and safety monitoring for adverse events. The main outcome measured is overall survival up to approximately 36 months after randomization. Secondary outcomes include progression-free survival, disease control rate, response duration, and safety assessments up to 36 months. The total study period extends until December 2028, with continuous monitoring of participant health and treatment effects.
CONDITIONS
Brief Title
Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years, regardless of gender
- ECOG Performance Status score of 0 or 1
- Expected survival of at least 8 weeks
- Histologically or cytologically confirmed extensive small cell lung cancer
- No prior systemic therapy or radical radiotherapy for extensive SCLC before enrollment
You will not qualify if you...
- Mixed tissue types of small cell lung cancer and non-small cell lung cancer
- Major surgery within 28 days before starting the study drug or planned during the study
- Receipt of live attenuated vaccines within 28 days before first dose or planned during the study
- Participation in another clinical trial with experimental agents within 28 days before dosing
- History of chest radiotherapy or plans for intensive chest radiotherapy before systemic therapy
- Previous treatments involving T-cell co-stimulation or immune checkpoint therapies
- History of allogeneic organ or hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of first-line treatment phase until disease progression or discontinuation
Participants receive Adebrelimab combined with chemotherapy with or without concurrent low-dose radiotherapy as part of their treatment for extensive-stage small cell lung cancer.
Multiple visits corresponding to treatment cycles as per protocol
Duration - Up to 36 months from randomization
Participants are monitored for safety and efficacy outcomes including adverse events and survival after completing treatment.
Regular visits for safety and disease status assessments up to 36 months
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Sichuan, China
Actively Recruiting
Research Team
Y
You Lu
Z
Zhuoran Yao, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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