Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC

Not yet recruiting

• Conditions: ALK-Positive NSCLC

• Registration Number: NCT06904547
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Study Start: 2025-04-20
• Primary Completion: 2029-06-30
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mechanisms of resistance to first-line lorlatinib	24 months	Reslstance Assessment; 1. Liquld Blops-Blood eIDNA NGS; 2. Tissue Biopsy (If applicablo)-NGS; mechanisms of resistance to first-line lorlatinib; 1. Propression pattern; * Priary ressstance; * Acquined resistance; 2. Moleculsr mechanisms of progression via ctDNA/organize NGS testing.; 3. Difference between the mnechsnisins of primary and acquired resistance

Secondary Outcome Measures

Name	Time	Method
Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib	24 months	1. rwTTD1： discontinuation of lorlatinib for any reason (including disease progression, death, severe adverse events, or patient choice); 2. rwTTD2： progression on first-line lorlatinib to discontinuation of the first sequential anti-tumor treatment for any reason (including disease progression, death, severe adverse events, or patient withdrawal from the study); 3. rwORR2: the overall proportion of patients who achieve complete response (CR) and partial response (PR); 4. rwDCR2: the overall proportion of patients who achieve complete response (CR), partial response (PR), and stable disease (SD); 5. rwPFS2: progression on first-line lorlatinib to disease progression or death from any cause or last confirmed survival 6、1-year/2-year-rwPFS2 rate: he proportion of patients who remain progression-free within 1 year/2 years; 7、the overall proportion of patients who survive within 1 year/2 years 8、Exploration of the proportion and related reasons for dose adjustment