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

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio. Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).

Conditions

• Limited-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX10	Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
DRUG	carboplatin/cisplatin-etoposide	Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice. Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.
RADIATION	Thoracic radiotherapy	Standard Thoracic Radiotherapy
DRUG	Placebo	Placebo Q3W
RADIATION	Prophylactic Cranial Irradiation (PCI)	PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Timeline

• Start date: 2022-05-17
• Primary completion: 2026-06-30
• Completion: 2028-05-30
• First posted: 2022-04-29
• Last updated: 2026-01-13

Locations

129 sites across 11 countries: United States, Austria, China, Czechia, Germany, Greece, Hungary, Latvia, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study