drugset / Trial / NCT05353257

A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

NCT05353257

Phase 3 Active not recruiting 511 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.

Timeline

Start
2022-05-17
Primary completion
2026-06-30
Completion
2028-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 300 mg
Background Carboplatin Small molecule 5 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous