drugset / Trial / NCT07154368

JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.

NCT07154368

Phase 3 Not yet recruiting 207 enrolled Guangzhou JOYO Pharma Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-23
Primary completion
2027-10-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject JYP0322 Unknown 150 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous