Lung Cancer Clinical Trial
To Evaluate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
Summary
This is a randomized, open-label study of HLX10 plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
Arm A (HLX10): HLX10 + chemotherapy (carboplatin-etoposide)
Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Eligibility 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.
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