NCT07154368

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: Guangzhou JOYO Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase III, open label, randomized study assessing JYP0322 (150 mg, orally, tid) versus platinum-based doublet chemotherapy in subjects with confirmed diagnosis of ROS1 fusion positive NSCLC, who have progressed following prior therapy with one or two approved ROS1 Tyrosine Kinase Inhibitor (ROS1-TKI) agents and whose tumors harbors a ROS1 fusion positive. Subjects must agree to provide a biopsy for central confirmation of ROS1 fusion status. A total of 207 patients will be randomly assigned in a 2:1 ratio to receive oral JYP0322 (at a dose of 150mg tid) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus carboplatin (target area under the curve 5 \[AUC5\]) every 3 weeks for up to six cycles. Patients without disease progression after four cycles of platinu

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	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
DRUG	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.
DRUG	JYP0322 tablets	JYP0322, 150 mg, administered orally three times daily (tid) after meals; sample size (N) = 60.

Timeline

• Start date: 2025-09-23
• Primary completion: 2027-10-31
• Completion: 2029-12-31
• First posted: 2025-09-04
• Last updated: 2025-09-19