Trial Number
642-26
Condition
Lung Cancer
Participant Age Range
18 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients with First-Line Extensive-Stage Small Cell Lung Cancer”
This study is for adults who have just been diagnosed with extensive‑stage small cell lung cancer (ES‑SCLC). Researchers are testing whether a new treatment called BL‑M14D1, given together with the immunotherapy atezolizumab, can help people live longer without their cancer getting worse compared to today’s standard treatments.
BL‑M14D1 is an antibody‑drug conjugate, a type of targeted therapy designed to find and attack cancer cells that have a protein called DLL3, which is commonly found in small cell lung cancer. Earlier studies suggest this treatment may help shrink tumors or slow their growth.
Participants in this study will be randomly assigned to one of two groups:
- Study treatment group: BL‑M14D1 plus atezolizumab
- Standard‑of‑care group: chemotherapy and immunotherapy commonly used today for ES‑SCLC
Doctors will monitor participants regularly with scans, blood tests, and health assessments to understand how well the treatments work and how safe they are. The main goal is to measure progression‑free survival—how long the cancer stays under control. Other goals include overall survival, tumor response, quality of life, and side‑effect monitoring.