NCT06612151 A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer
| NCT ID | NCT06612151 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 438 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2027-12-01 |
Trial Parameters
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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).
Eligibility Criteria
Inclusion Criteria: 1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. 2. Aged ≥18 and ≤75 years, male or female. 3. ECOG PS 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed SCLC. Subjects with combined SCLC or any transformed SCLC are not eligible. 6. Has limited-stage or extensive-stage disease at study entry, with progression on or after first-line platinum-based therapy (at least 2 cycles). 7. At least one measurable lesion according to RECIST version 1.1. 8. Subjects are willing to provide tumor tissue (freshly obtained or archived) for detection of B7-H3 expression. 9. Adequate organ function. Exclusion Criteria: 1. History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects cured by radical treatment are not included, such as basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of the cervix, or breast
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