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RECRUITING
NCT05957510
PHASE2

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

Sponsor: Guangdong Association of Clinical Trials

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-07-10

Completion Date

2026-12-31

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

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

Locations (1)

Guangdong Provincial Perople's Hospital

Guangzhou, Guangdong, China