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

NCT07154368 | Not Yet Recruiting Phase 3

• 1 other identifier: JYP0322M302
• Study Type: interventional
• Target: 207
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) by BICR Assessment

  Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomization until the date of PD (by BICR assessment) or death (due to any cause) regardless of whether the patient withdrew from randomized therapy. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.

  UP to 3 years

Secondary Outcomes (6)

• Progression Free Survival (PFS) by investigators Assessment

  UP to 3 years

• Overall Survival (OS)

  UP to 5 years

• Objective Response Rate (ORR) by Investigator and BICR assessment

  RECIST tumor assessments every 6 weeks from randomization up to 3 years.

• Duration of Response (DOR) by Investigator and BICR assessment

  RECIST tumor assessments every 6 weeks from randomization up to 3 years.

• Disease Control Rate (DCR) by Investigator and BICR assessment

  RECIST tumor assessments every 6 weeks from randomization up to 3 years.

Study Arms (2)

JYP0322 tablets

EXPERIMENTAL

Drug: JYP0322 tablets

Pemetrexed Disodium

EXPERIMENTAL

Drug: Pemetrexed injection; Drug: Cross-over to JYP0322

Interventions

Pemetrexed injection DRUG

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

Pemetrexed Disodium

Cross-over to JYP0322 DRUG

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.

Pemetrexed Disodium

JYP0322 tablets DRUG

JYP0322, 150 mg, administered orally three times daily (tid) after meals; sample size (N) = 60.

JYP0322 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically or cytologically documented NSCLC.
• Locally advanced or metastatic ROS1 fusion positive NSCLC.
• Prior one or two ROS1-TKI(s) Treatment.
• World Health Organization (WHO) performance status 0-1.
• Life expectancy of at least 3 months.
• At least one measurable lesion according to RECISIT 1.1.

You may not qualify if:

• Current participation in another therapeutic clinical trial.
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
• A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
• All acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade more than 1.
• Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
• Known active infe

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Li Zhang, M.D

CONTACT

86-020-87343458; zhangli@sysucc.org.cn

Danyang Liu, Master

CONTACT

86-020-22320385; dyliu@joyopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two arms

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 4, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share