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

NCT07154368 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2025-09-19

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Guangzhou JOYO Pharma Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2027-10-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154368 on ClinicalTrials.gov