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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

September 23, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

December 31, 2029

Conditions
Non Small Cell Lung Cancer
Interventions
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.

All Listed Sponsors
lead

Guangzhou JOYO Pharma Co., Ltd

INDUSTRY