Study of Lorlatinib With or Without Local Consolidation Therapy in Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with advanced non-small cell lung cancer NSCLC that has a specific genetic change called ALK rearrangement. This phase 2 trial focuses on patients who have not previously received tyrosine kinase inhibitors TKIs and aims to compare the time patients live without cancer progression when treated with lorlatinib alone versus lorlatinib combined with local consolidation therapy LCT. The study also seeks to assess safety, overall survival, and molecular markers related to treatment resistance. Participants initially receive lorlatinib, an oral medication, daily for 12 weeks before randomization. Some patients who have been on other first-line ALK TKIs for up to 4 weeks and switched to lorlatinib will also complete a total of 12 weeks on lorlatinib prior to randomization. The trial has two experimental groups one receiving lorlatinib alone, and the other receiving lorlatinib plus local consolidation therapy. The study includes biomarker evaluations using blood and tissue samples collected before and after LCT. During the trial, participants undergo various assessments including safety monitoring for adverse events over about one year. Researchers will collect blood samples to study circulating tumor DNA and perform biopsies after disease progression to understand resistance mechanisms. Participants must provide informed consent and comply with study procedures, with ongoing evaluations of organ function, heart health, and pregnancy status as part of eligibility and safety monitoring. The total study duration and follow-up depend on individual participant progress.

Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer