A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC (NCT07491497) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
United States160 participantsStarted 2026-03-11
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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 CNS disease
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Treatment emergent adverse events
Timeframe: Within 28 days of the first TRI-611 dose
2
Part 2: Objective response rate (ORR)
Timeframe: Approximately 16 weeks after the last participant dosed in Part 2
3
Part 2: Depth of response (DofR)
Timeframe: Approximately 16 weeks after the last participant dosed in Part 2