Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT07154368
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 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
Study:
NCT07154368
Study Brief:
Protocol Section:
NCT07154368