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.
Voluntarily sign the written informed consent form and comply with the protocol requirements
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.
MediLink Therapeutics (Suzhou) Co., Ltd.
Lead sponsor
Shanghai Henlius Biotech
Collaborator