Clinical Trial: NCT06500026
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-04-17 |
Study Overview
Brief 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.
Official Title
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
Conditions
Small Cell Lung Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Topotecan
Other Study ID Numbers
- BL-B01D1-304
Start Date (Actual)
2024-08-07
Primary Completion Date (Estimated)
2026-12
Study Completion Date (Estimated)
2026-12
Enrollment (Actual)
722
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-04-17 |
Study Overview
Brief 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.
Official Title
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
Conditions
Small Cell Lung Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Topotecan
Other Study ID Numbers
- BL-B01D1-304
Start Date (Actual)
2024-08-07
Primary Completion Date (Estimated)
2026-12
Study Completion Date (Estimated)
2026-12
Enrollment (Actual)
722
Study Type
Interventional
Phase
Phase 3