Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for LS-SCLC Guided by MRD

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07357532
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab Injection — DRUG
    Patients with MRD Positive will receive adebrelimab (1200 mg, D1, Q3W) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.
  • Apatinib Mesylate Tablets — DRUG
    Apatinib Mesylate Tablets (250 mg, QD) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.

Study Details

This study plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted next-generation sequencing to investigate the correlation between molecular residual disease (MRD) status and tumor recurrence/metastasis. For patients with MRD-positive results, a therapeutic strategy combining immunotherapy with anti-angiogenic agents will be implemented with the aim of improving clinical outcomes.

Key Dates

Start date
Jan 31, 2026
Status verified
Dec 2025
Primary completion
Sep 26, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MRD-positive group
    The specific dosing regimen is as follows: Adebrelimab: Intravenous infusion, 1200 mg, administered on Day 1 of each cycle, once every 3 weeks. Apatinib: Oral administration, 250 mg, once daily. Patients with limited-stage small cell lung cancer who have completed all radical chemoradiotherapy (prophylactic cranial irradiation is permitted) and test positive for MRD upon enrollment, without prior use of immune checkpoint inhibitors, will receive adebrelimab combined with apatinib according to the above dosing regimen. Treatment with adebrelimab and apatinib will continue, along with ongoing ctDNA monitoring. The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.

Primary Outcome Measure

Negative conversion rate of MRD [ Time Frame: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first. ]

Central Contacts

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