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New treatment option for ALK-positive NSCLC
Official title A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
ClinicalTrials.gov ID: NCT07491497
What this study is testing
What is TRI-611?
TRI-611 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alk-positive nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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, 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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, 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Maumee, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Aurora, Colorado, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; New York, New York, United States; Maumee, Ohio, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.