Active Not RecruitingPhase 3NCT05353257

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

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.

Checked against the public recordLast updated Jan 13, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations129
SponsorShanghai Henlius Biotech
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Shanghai Henlius Biotech
Interventions being studied
Drug: HLX10; Drug: carboplatin/cisplatin-etoposide; Radiation: Thoracic radiotherapy; Drug: Placebo; Radiation: Prophylactic Cranial Irradiation (PCI)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Male or female, aged ≥18 years when signing the ICF. 2. Histologically diagnosed with SCLC. 3. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses. 4. Major organs are functioning well. Exclusion Criteria: 1. Histologically or cytologically confirmed mixed SCLC. 2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included. 3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy. 4. Patients with other active malignancies within 5 years or at the same time. 5. Subjects with known history of severe allergy to any monoclonal antibody. 6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide. 7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • OPN-GlendaleArcadia, California
  • OPN-Los AlamitosLos Alamitos, California
  • Southern California Permanente GroupLos Angeles, California
  • Emad Ibrahim, MD, IncRedlands, California
  • Providence Medical FoundationSanta Rosa, California
  • Lutheran Medical Center - Cancer Centers of ColoradoGolden, Colorado
  • Eastern Connecticut Hematology & Oncology AssociatesNorwich, Connecticut
  • Cancer Specialists of North FloridaJacksonville, Florida
  • Mid Florida Hematology and Oncology CenterOrange City, Florida
  • Advent Health OrlandoOrlando, Florida
  • Napa ResearchPompano Beach, Florida
  • Kansas University Mediacal CenterFairway, Kansas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 13, 2026. Always confirm current availability with the study team.

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