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JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.
Sponsor: Guangzhou JOYO Pharma Co., Ltd
Summary
The primary purpose of the study was to compare progression-free survival of JYP0322 vs. platinum-based doublet chemotherapy in patients previously treated with ROS1-TKIs. Patients in the chemotherapy arm are given the option to switch to JYP0322 after BICR confirmed progressive disease (PD), while also have the choice to pursue with other drugs after discussing with their physicians.
Official title: A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2025-09-23
Completion Date
2029-12-31
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
Pemetrexed injection
Randomization to either JYP0322 or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (JYP0322: platinum-based doublet-chemotherapy) ratio
Cross-over to JYP0322
Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by BICR, they will be given the opportunity to begin treatment with JYP0322 150mg tid. These subjects may continue treatment with JYP0322 if they are continuing to show clinical benefit until disease progression as judged by the investigator.
JYP0322 tablets
JYP0322, 150 mg, administered orally three times daily (tid) after meals; sample size (N) = 60.