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Clinical trialNCT07491497RecruitingPhase 1/PHASE2Interventional

A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC

SponsorTRIANA Biomedicines, Inc.Enrollment160ALK-Positive Lung CancerALK-positive NSCLCALK-positive Non-small Cell Lung Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC. The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received. In this study participants will: * Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing * Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter * Keep a diary of each time they take the study medication

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Ucsf

    San Francisco, California, United States

    Collin Blakely, MD
    Recruiting
  • University of Colorado Cancer Center

    Aurora, Colorado, United States

    Kyle Concannon, MD
    Recruiting
  • Dana Farber Cancer Center

    Boston, Massachusetts, United States

    Alice Shaw, MD
    Recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Jessica Lin, MD
    Recruiting
  • Washington University Medical Center

    St Louis, Missouri, United States

    Saiama Waqar, MD
    Recruiting
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, United States

    Alexander Drilon, MD
    Recruiting
  • Duke University

    Durham, North Carolina, United States

    Thomas Stinchcombe, MD
    Recruiting
  • Taylor Cancer Research Center

    Maumee, Ohio, United States

    John Nemunaitis, MD
    Recruiting
  • Scri Oncology Partners

    Nashville, Tennessee, United States

    Melissa Johnson, MD
    Recruiting
  • Oncology Consultants Research (p1 Trials)

    Houston, Texas, United States

    Julio Peguero, MD
    Recruiting
  • Start Mountain Region

    West Valley City, Utah, United States

    José Pacheco, MD
    Recruiting
  • Next Virginia

    Fairfax, Virginia, United States

    Alexander Spira, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Mar 2026
Primary completion
31 May 2029
Completion
30 Jan 2034
Last update posted
27 Jul 2026
Registered enrollment
160
Registry id
NCT07491497

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.