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

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

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	2026-03-11
Primary Completion	2029-05-31 (estimated)
Study Completion	2034-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-27