NCT07415005

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lorlatinib	Given Orally

Timeline

• Start date: 2026-08-31
• Primary completion: 2028-07-22
• Completion: 2030-07-22
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States