M.D. Anderson Cancer Center
This is an open-label, multicenter, randomized phase 2 trial for patients with tyrosine kinase inhibitor-naïve ALKrearranged advanced NSCLC. Subjects are initially treated with lorlatinib for 12 weeks.
Primary Objective: 1\. To compare the PFS of ALK+ NSCLC patients treated with lorlatinib to those treated with lorlatinib and local consolidation therapy (LCT) Secondary Objectives: 1. To assess the safety and tolerability of lorlatinib and LCT. 2. To increase trial enrollment in underserved population 3. To determine overall survival (OS) in patients treated with single agent lorlatinib vs lorlatinib plus LCT. 4. To assess the time to progression of non-LCT lesions in the lorlatinib plus LCT arm. Exploratory Biomarkers Objectives: 1. To determine the utility of pre-treatment, pre-LCT, an…
Inclusion Criteria: Subjects must meet all the following criteria to be included in this study: 1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy) 2. Documented ALK re-arrangement as detected by: (1) FISH, (2) IHC, (3) tissue NGS, or (4) cfDNA NGS 3. Subjects can be enrolled as (a) TKI naïve or (b) after/during 12 weeks of first line lorlatinib treatment without disease progression or (c) ≤4 weeks of first line alectinib, brigatinib or ensartinib treatment without disease progression, those patien…
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