Clinical Trial: NCT06612151
A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (TAISHAN-302)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Information Provided By: | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Last Update Posted: | 2026-09-15 |
Study Overview
Brief Summary
This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).
Official Title
A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer
Conditions
Small Cell Lung Cancer
Intervention / Treatment
- Drug: YL201
- Drug: topotecan hydrochloride for injection
Other Study ID Numbers
- YL201-CN-302-01
Start Date (Actual)
2024-12-17
Primary Completion Date (Estimated)
2027-12-01
Study Completion Date (Estimated)
2030-12-01
Enrollment (Estimated)
438
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Information Provided By: | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Last Update Posted: | 2026-09-15 |
Study Overview
Brief Summary
This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).
Official Title
A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer
Conditions
Small Cell Lung Cancer
Intervention / Treatment
- Drug: YL201
- Drug: topotecan hydrochloride for injection
Other Study ID Numbers
- YL201-CN-302-01
Start Date (Actual)
2024-12-17
Primary Completion Date (Estimated)
2027-12-01
Study Completion Date (Estimated)
2030-12-01
Enrollment (Estimated)
438
Study Type
Interventional
Phase
Phase 3