A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)
This is a randomized, open-label study of Serplulimab 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 (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
• Voluntary participation in clinical studies.
• Male or female aged ≥ 18 years at the time of signing the ICF.
• Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
• No prior systemic therapy for ES-SCLC.
• At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
• Major organs are functioning well.
• Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
• An ECOG PS score of 0 or 1.
• An expected survival ≥ 12 weeks.
• Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.
• Participant must keep contraception.