At a glance
ClinicalIndex Comparison RecordPhase 3Active· 722 enrolled
Drug / intervention
BL-B01D1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy
In Brief
A Phase 3 clinical trial evaluating BL-B01D1 and Topotecan for Small Cell Lung Cancer. Active but no longer recruiting, targeting 722 participants across 1 site.
Detailed Summary
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent small cell lung cancer after failure of anti-PD-1/PD-L1 Monoclonal Antibodies and platinum-based chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesChina
CollaboratorsBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Timeline
Phase 3Active
202520262027
First PostedJul 2024
Enrollment StartAug 2024
TodayJul 2026
Primary CompletionDec 2026
First PostedJul 15, 2024
Enrollment StartAug 7, 2024
Primary CompletionDec 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 2.0 years agoPrimary completion in 5 months
Interventions
BL-B01D1drug
Administration by intravenous infusion for a cycle of 3 weeks.
Topotecandrug
Administration by intravenous infusion for a cycle of 3 weeks.