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Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer

NCT07583550 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-05-13

No results posted yet for this study

Summary

This multicenter, prospective study aims to investigate the efficacy and safety of low-dose radiotherapy (15Gy/1.5 Gy bid × 10 fractions) combined with 4-6 cycles of systemic chemotherapy plus anti-PD-L1 antibody, followed by anti-PD-L1 antibody maintenance for up to two years, in participants with extensive-stage small cell lung cancer (ES-SCLC).

Additionally, dynamic monitoring using next-generation sequencing (NGS) technology will be performed to assess ctDNA levels, genetic information, and mutation abundance at the following time points: before and after low-dose radiotherapy, after 4-6 cycles of chemotherapy plus anti-PD-L1 antibody (chemotherapy-immunotherapy), and before the initiation of anti-PD-L1 maintenance therapy. This approach aims to guide efficacy and prognosis prediction, as well as to identify potential biomarkers associated with treatment response.

Conditions

Interventions

RADIATION

Thoracic Radiotherapy

Radiotherapy will be delivered to the primary tumor in the lung, involved regional lymph nodes, and metastatic pleural lesions.

DRUG

Etoposide

Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).

DRUG

Cisplatin

Etoposide 100 mg/m² intravenously on days 1-3, plus Cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days (q3w).

DRUG

Carboplatin

Etoposide 100 mg/m² intravenously on days 1-3, plus Carboplatin area under the curve (AUC) 5 intravenously on day 1, repeated every 21 days (q3w).

DRUG

Adebrelimab

20 mg/kg intravenously on day 1, repeated every 21 days (q3w). Administered concurrently with chemotherapy for 4-6 cycles, followed by maintenance monotherapy for up to 2 years.

Sponsors & Collaborators

  • Jiangmen Central Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-10-30
Completion
2028-01-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583550 on ClinicalTrials.gov