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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHLX10 and carboplatin/cisplatin-etoposide

Plus 3 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

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

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?129 U.S. locations

Locations may change over time.

Who runs it?Shanghai Henlius Biotech

Study sponsor

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)

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How this study is categorized

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

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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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