NCT05957510

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

Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants with EGFR-mutant NSCLC who were transformed into SCLC after treatment and did not undergo systemic anticancer therapy after transformation will be divided into three cohorts. We plan to enroll 36 patients in the first cohort, and 18 patients in the second cohort. Participants in cohort 1 and cohort 2 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. Participants in cohort 3 will be treated with the clinical routine treatment recommended by the investigator.

Conditions

• Small-cell Lung Cancer

Interventions

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

Timeline

• Start date: 2023-07-10
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2023-07-24
• Last updated: 2026-04-03

Locations

1 site across 1 country: China