RecruitingPhase 2NCT06812260

A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC

A Single-arm, Open-label, Phase II Study to Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)


Sponsor

Shanghai Henlius Biotech

Enrollment

26 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a combination of HLX10 (an immunotherapy drug) with standard chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) — an aggressive form of lung cancer that has spread beyond the chest at diagnosis. **You may be eligible if...** - You are 18 or older - You have been diagnosed with extensive-stage small cell lung cancer confirmed by biopsy - You have not yet received any treatment for ES-SCLC - If you had prior limited-stage SCLC, your last treatment was at least 6 months ago and was given with curative intent **You may NOT be eligible if...** - You have already received systemic treatment for ES-SCLC - You have autoimmune conditions that could be worsened by immunotherapy - Your organ function (heart, liver, lungs) is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX10+chemo

Treatment arm


Locations(1)

Kansai Medical University Hospital Department of Respiratory Oncology

Hirakata, Osaka, Japan

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NCT06812260


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