Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes. A 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare. The current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC. This is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.
Age range
18 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
MTD
Timeframe: Throughout the study for approximately 2 years
RP3D
Timeframe: Throughout the study for approximately 2 years