Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT05957510
Phase
PHASE2
Status
Recruiting
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Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.
  • SOC — DRUG
    the treatment recommended by the investigator

Study Details

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment.

Key Dates

Start date
Jul 7, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients who met the inclusion criteria, did not meet the exclusion criteria, and agreed to accept the treatment plan of this study will undertake a combination chemotherapy regimen, comprised of serplulimab (300mg), etoposide (100 mg/m2), and carboplatin (AUC 5 mg/mL/min, up to 750mg). These agents will be administered intravenously in 3-week intervals over a span of 4 to 6 cycles.
  • Experimental: Cohort 2
    Patients who met the specific inclusion criteria, did not meet the specific exclusion criteria, and agreed to accept the treatment of this study will undertake the same treatment as cohort 1 in the form of ' compassionate use '.
  • Experimental: Cohort 3
    Patients with treatment contraindications or unwillingness to accept the treatment of this study will be treated with the clinical routine treatment recommended by the investigator.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years. ]

Central Contacts

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