RecruitingPhase I/IIEN originalLung cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rozpoznanie raka płuca bez drobnych komórek z mutacją ALK
  • Mierzalne zmiany nowotworowe
  • Prawidłowe funkcje szpiku kostnego i narządów
  • Wcześniejsze leczenie innymi lekami przeciw ALK (od 2 do 3 leków w zależności od grupy)
  • Wcześniejsze leczenie lekiem lorlatinib, ale nie jako pierwsza terapia

✗ Disqualifies

  • Nowotwór ma dodatkowe mutacje powodujące opór na leki przeciw ALK
  • Przerzuty do mózgu lub rdzenia kręgowego z postępującymi objawami neurologicznymi
  • Jednoczesne leczenie innymi lekami przeciwnowotworowymi
  • Alergia na TRI-611 lub jego składniki
  • Duża operacja chirurgiczna w ciągu 4 tygodni przed rozpoczęciem leczenia

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 14, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (11)

UCSF

San Francisco, United States

University of Colorado Cancer Center

Aurora, United States

Massachusetts General Hospital

Boston, United States

Dana Farber Cancer Center

Boston, United States

Washington University Medical Center

St Louis, United States

Memorial Sloan-Kettering Cancer Center

New York, United States

Taylor Cancer Research Center

Maumee, United States

SCRI Oncology Partners

Nashville, United States

Oncology Consultants Research (P1 Trials)

Houston, United States

START Mountain Region

West Valley City, United States

NEXT Virginia

Fairfax, United States

Trial contact

TRIANA Clinical Trials

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/15/2026.

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