Actively Recruiting
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Led by TRIANA Biomedicines, Inc. · Updated on 2026-05-07
160
Participants Needed
7
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)
- Measurable disease based on RECIST v1.1 criteria
- Adequate bone marrow and organ function
- For Part 1: Prior treatment with 2 to 3 ALK tyrosine kinase inhibitors (TKIs), including prior lorlatinib treatment not as first-line therapy
- For Part 2 Cohort M1: Prior treatment with 2 to 3 ALK TKIs, including prior lorlatinib treatment not as first-line therapy, and no prior treatment with neladalkib
- For Part 2 Cohort M2: Prior treatment with more than 3 ALK TKIs, including prior treatment with lorlatinib and neladalkib, neither as first-line therapy
- For Part 2 Cohort M3: No prior ALK TKI treatment
You will not qualify if you...
- Cancer has additional driver alterations known to cause resistance to ALK TKIs
- Central nervous system metastases or spinal cord compression with progressive neurological symptoms or requiring increasing corticosteroids
- Currently receiving any other anticancer treatment or investigational agent
- Known allergy or hypersensitivity to TRI-611 or its ingredients
- Major surgery within 4 weeks before receiving the first dose of TRI-611
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Washington University Medical Center
St Louis, Missouri, United States, 63130
Actively Recruiting
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
5
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
7
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
T
TRIANA Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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