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A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Trial Status: active
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
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07491497.
