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New hope for ROS1-Positive lung cancer: JYP0322 takes on chemo

NCT ID NCT07154368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial compares a new drug called JYP0322 with standard platinum-based chemotherapy in 207 people with advanced ROS1-positive non-small cell lung cancer who have already been treated with ROS1-targeted therapy. The main goal is to see if JYP0322 delays cancer growth better than chemotherapy. Patients on chemotherapy can switch to JYP0322 if their cancer worsens.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JYP0322
What this could lead to
If successful, JYP0322 could offer a new treatment option for people with ROS1-positive lung cancer whose disease has progressed after initial targeted therapy.
What could go wrong
This is an early-stage Phase 3 trial with only 207 participants, so results may not apply to everyone. The drug may not improve survival or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 207 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Key Inclusion Criteria * 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. Exclusion Criteria: * Key Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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