Status:
NOT_YET_RECRUITING
JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.
Lead Sponsor:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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,...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Subjects with histologically or cytologically documented NSCLC.
- Locally advanced or metastatic ROS1 fusion positive NSCLC.
- Prior one or two ROS1-TKI(s) Treatment.
- World Health Organization (WHO) performance status 0-1.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to RECISIT 1.1.
Exclusion
- Key
Key Trial Info
Start Date :
September 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT07154368
Start Date
September 23 2025
End Date
December 31 2029
Last Update
September 19 2025
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