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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Limited-Stage Small Cell Lung Cancer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jinming Yu, MD · Shandong Cancer Hospital & Institute-department

  • Ying Cheng · Jilin Provincial Tumor Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2026-06-30
Completion
2028-05-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • China
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Latvia
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353257 on ClinicalTrials.gov