Actively Recruiting
A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC
Led by Shanghai Henlius Biotech · Updated on 2025-09-17
26
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and able to complete all study procedures
- Male or female aged 18 years or older
- Diagnosed with extensive stage small cell lung cancer (ES-SCLC)
- No prior systemic therapy for ES-SCLC
- If previously treated for limited stage SCLC, treatment was curative and at least 6 months have passed since last therapy
- At least one measurable tumor lesion according to RECIST 1.1 within 4 weeks before first dose
You will not qualify if you...
- Mixed small cell lung cancer confirmed by histology or cytology
- Other active cancers within 5 years except certain cured localized tumors (e.g., basal cell carcinoma, cervical cancer in situ)
- Preparing for or received organ or bone marrow transplant
- Uncontrolled pleural, pericardial effusion, or ascites needing drainage at least monthly
- Active central nervous system metastases or carcinomatous meningitis (except stable or asymptomatic brain metastases under specific conditions)
- Untreated spinal cord compression
- Myocardial infarction within 6 months before first dose or poorly controlled arrhythmia
- Severe heart failure (NYHA class III-IV) or low heart function (LVEF <50%)
- Uncontrolled or symptomatic high calcium levels
- Peripheral neuropathy grade 2 or higher
- HIV infection
- Active or latent pulmonary tuberculosis
- Previous or current lung diseases affecting lung toxicity assessment
- Hepatitis B or C infection
- Known active or suspected autoimmune diseases requiring immunosuppressant therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kansai Medical University Hospital Department of Respiratory Oncology
Hirakata, Osaka, Japan
Actively Recruiting
Research Team
R
Rongfei Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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