About this trial
This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
Age ≥ 18 years;
Expected survival time ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Disqualifiers
Pathology indicates small cell carcinoma containing non-small cell carcinoma components;
Patients who have previously received systemic treatment;
Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;
Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;
Trial design
Treatments tested in this trial
- BL-B01D1
- Tislelizumab
- Carboplatin
- Etoposide
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator