A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10+Chemotherapy in Patients With Extensive Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2024-05-29
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Carboplatin; Etoposide

Criteria

Inclusion Criteria:

• Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)

• No prior systemic therapy for ES-SCLC

• Major organs are functioning well

• Participant must keep contraception

Exclusion Criteria:

• Histologically or cytologically confirmed mixed SCLC

• Known history of severe allergy to any monoclonal antibody

• Known hypersensitivity to carboplatin or etoposide

• Pregnant or breastfeeding females

• Patients with a known history of psychotropic drug abuse or drug addiction

• Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment