This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of YL201 in combination with serplulimab versus standard-of-care carboplatin and etoposide in combination with serplulimab as first-line treatment in patients with extensive-stage small cell lung cancer.
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Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
Any histological types of transformed SCLC or combined SCLC.
History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy.
Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period.
History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Parallel
YL201
DrugYL201 will be administered by intravenous infusion at a dose of 2.0 mg/kg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed,
Serplulimab
DrugSerplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years.
Carboplatin
DrugCarboplatin will be administered by intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle. Carboplatin treatment will be administered for up to 4 cycles.
Etoposide
DrugEtoposide will be administered by intravenous infusion at a dose of 100 mg/m2 on Days 1 to 3 of each 3-week cycle. Etoposide treatment will be administered for up to 4 cycles.
Overall survival (OS)
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. OS was estimated using KM methodology.
Progression-free survival (PFS) as assessed by BIRC
PFS, as assessed by Blinded Independent Review Committee (BIRC), is defined as the time from randomization to the first documented progressive disease (PD) based on BIRC imaging assessment, or death from any cause, whichever occurs first.
Progression-free survival (PFS) as assessed by investigator
PFS assessed by investigator is defined as the time from randomization to the first documented PD based on investigator assessment, or death from any cause, whichever occurs first.
Objective response rate (ORR)
ORR is defined as the percentage of participants with (confirmed) complete response or partial response as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease control rate (DCR)
DCR is defined as the percentage of participants with (confirmed) complete response, partial response, or stable disease as assessed according to RECIST v1.1
Duration of response (DOR)
DOR is defined as the time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
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MediLink Therapeutics (Suzhou) Co., Ltd.
Lead sponsor
Shanghai Henlius Biotech
Collaborator
