207
Participants
Start Date
September 23, 2025
Primary Completion Date
October 31, 2027
Study Completion Date
December 31, 2029
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
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.
JYP0322 tablets
JYP0322, 150 mg, administered orally three times daily (tid) after meals; sample size (N) = 60.
Guangzhou JOYO Pharma Co., Ltd
INDUSTRY