A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)

Recruiting Phase 3 Interventional Study
Extensive-stage Small-cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
562 (estimated)
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age ≥ 18 years; 3. Expected survival time ≥ 3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. Patients with histopathologically and/or cytologically …
Contacts

Sa Xiao, PHD

15013238943

xiaosa@baili-pharm.com

CONTACT