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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 12 → 16 locations Eligibility criteria expanded, about 8 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 11 to 12v8
  3. Study sites: 9 to 11v7
  4. Study sites: 7 to 9v6
  5. Study sites: 5 to 7v5
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  1. Site contacts updated at 4 of 5 sitesv4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 31, 2026 to Mar 11, 2026v2 Show 1 more changeShow less
    • Start date changed from estimate of Mar 31, 2026 to Mar 11, 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07491497
Lead Sponsor TRIANA Biomedicines, Inc.
Conditions ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov