Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07415005
Brief Summary:
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.
Detailed Description:
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, and post-LCT circulating free tumor DNA (cfDNA) as potential prognostic and predictive biomarkers.
2. To evaluate potential impact of LCT on mechanisms of lorlatinib resistance with molecular analysis of postprogression biopsies.
Study:
NCT07415005
Study Brief:
Protocol Section:
NCT07415005