A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
• Male or female participants between 18 and 75 years old.
• Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):
‣ Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
⁃ Cohort 2\
∙ 3: participant has received no prior systemic treatment.
• Agree to provide fresh or archival tumor tissue for biomarker analysis.
• Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy \>= 12 weeks.
• Has adequate organ and bone marrow functions.
• Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
• Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.
⁃ Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.