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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
• Aged ≥18 and ≤75 years, male or female.
• ECOG PS 0 or 1.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed SCLC. Subjects with combined SCLC or any transformed SCLC are not eligible.
• Has limited-stage or extensive-stage disease at study entry, with progression on or after first-line platinum-based therapy (at least 2 cycles).
• At least one measurable lesion according to RECIST version 1.1.
• Subjects are willing to provide tumor tissue (freshly obtained or archived) for detection of B7-H3 expression.
• Adequate organ function.
Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Xianfeng Zhu
xianfeng.zhu@medilinkthera.com
+86 512 6285 8368
Backup
Xian Zhang
zhangxian@medilinkthera.com
+86 512 6285 8368
Time Frame
Start Date:2024-12-17
Estimated Completion Date:2030-12-01
Participants
Target number of participants:438
Treatments
Experimental: YL201
Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.
Active_comparator: topotecan hydrochloride for injection
Participants are randomized to receive topotecan hydrochloride intravenously, on Days 1 to 5 of each 3-week cycle per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol.