Phase II Study of BL-B01D1 and PD-1 Monoclonal Antibody Treatment in Adults with Extensive-stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the combination of BL-B01D1 and a PD-1 monoclonal antibody in patients with extensive-stage small cell lung cancer. This phase II clinical trial aims to explore the safety and effectiveness of this combination therapy as a potential treatment option for this condition. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. and focuses on patients newly diagnosed with this type of lung cancer. Participants receive BL-B01D1 and the PD-1 monoclonal antibody through intravenous infusions during the first treatment cycle lasting three weeks. Those who show clinical benefit may continue with additional treatment cycles until disease progression, intolerable toxicity, or other reasons require stopping the therapy. Both drugs are administered together in this single-group study design. Throughout the trial, participants undergo regular assessments to monitor tumor response, progression-free survival, disease control, duration of response, and any treatment-related adverse events for up to approximately 24 months. Before and during treatment, participants provide tissue samples and undergo evaluations including imaging and laboratory tests. The study involves periodic visits and careful monitoring to assess both the effectiveness and safety of the combination therapy over the course of participation.

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer