This is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of JYP0322 compared with crizotinib in previously untreated ROS1-positive locally advanced or metastatic non-small cell lung cancer.
Voluntary participation and signed written informed consent (ICF) before any study-specific procedure.
ANC ≥ 1.5 × 10^9/L
Platelets ≥ 100 × 10^9/L
Hemoglobin ≥ 90 g/L (stable erythropoietin ≥3 months allowed)
History of severe cardiovascular or cerebrovascular disease, including but not limited to: clinically significant cardiac rhythm or conduction abnormality (e.g., ventricular arrhythmia requiring intervention, 2nd-3rd degree AV block); acute coronary syndrome, congestive heart failure, aortic dissection, severe stable/unstable angina, coronary/peripheral vascular intervention, stroke or other ≥Grade 3 cerebrovascular event (including TIA), pulmonary embolism, DVT or other clinically significant thrombosis within 6 months before randomization; NYHA > Class II heart failure or LVEF < 50%; any uncontrolled atrial fibrillation; QTcF > 470 ms or symptomatic bradycardia < 45 bpm; known congenital long QT syndrome or history of QT prolongation.
Parallel
JYP0322 Tablets
DrugOral administration, 150 mg each dose, three times daily (TID), continuous dosing.
Crizotinib Capsules
DrugOral administration, 250 mg twice daily (BID), continuous dosing.
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR/BIRC) per RECIST v1.1
PFS is defined as the time from randomization to the first occurrence of radiographic disease progression determined by blinded independent central review (BIRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause within 12 weeks after last tumor assessment (to avoid censoring death as non-event if no progression documented). Patients alive and without progression at data cutoff are censored at the date of last adequate tumor assessment.
Investigator-assessed Progression-Free Survival (PFS) per RECIST v1.1
PFS assessed by the local investigator using the same RECIST v1.1 criteria and scan schedule as the BIRC pathway, but without blinding to treatment assignment. Defined as time from randomization to first investigator-determined radiographic disease progression, or death from any cause (if no prior progression). No central adjudication. Used for sensitivity analysis against the primary BIRC-based PFS.
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. Patients alive at the time of data cutoff will be censored at the last known alive date. OS will be estimated using the Kaplan-Meier method and compared between arms by log-rank test; hazard ratio and 95% CI from Cox proportional hazards model reported.
Incidence, severity, and relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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