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New pill shows promise against tough lung cancer

NCT ID NCT07491497

Disease control Sponsor: TRIANA Biomedicines, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This study tests a new daily pill called TRI-611 for adults with advanced ALK-positive non-small cell lung cancer (NSCLC) that has not responded to other treatments. The trial has two parts: first, finding the safest dose, and second, seeing how well it shrinks tumors in different groups based on prior therapy. About 160 participants will take the drug as long as it helps and is safe.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 160 people

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

Started

Mar 2026

Expected to finish

Jan 2034

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: * Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC) * Measurable disease per RECIST v1.1 * Adequate bone marrow reserve and organ function * Part 1: prior treatment with 2 to 3 ALK TKIs \[in US only: '2 or more ALK TKIs'\], prior treatment with lorlatinib is required but must not have been in the first line * Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded * Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line * Part 2 Cohort M3: participants without prior ALK TKI treatment Exclusion Criteria: * Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs * For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease * Ongoing treatment with another anticancer treatment or investigational agent * Known allergy/hypersensitivity to TRI-611 or any of its ingredients * Major surgery within 4 weeks of receiving the first dose of TRI-611

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Conditions

The condition(s) this trial relates to.

lung carcinoma non-small cell lung carcinoma

As listed by the trial registrant

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

ALK-positive lung cancer ALK-positive non-small-cell lung cancer ALK-positive NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dana Farber Cancer Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710-2000, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Oncology Consultants Research (P1 Trials)

    RECRUITING

    Houston, Texas, 77030, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Royal North Shore Hospital

    RECRUITING

    Sydney, New South Wales, 2000, Australia

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START-Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94158, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Cincinnati Cancer Center

    RECRUITING

    Cincinnati, Ohio, 45221, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Washington University Medical Center

    RECRUITING

    St Louis, Missouri, 63130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.