Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 1:09 AM
Study NCT ID:
NCT07415005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2026-01061 | OTHER | NCI-CTRP Clinical Trials Registry | View |