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

NCT06904547 | Not Yet Recruiting DMC

• 1 other identifier: IS25052
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ALK-Positive NSCLC

Outcome Measures

Primary Outcomes (1)

• mechanisms of resistance to first-line lorlatinib

  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

  24 months

Secondary Outcomes (1)

• Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib

  24 months

Other Outcomes (1)

• To determine the optimal sequential treatment strategies for different resistance mechanisms and the impact of these resistance mechanisms on patient outcomes in sequential treatment

  24 months

Interventions

No intervention administered OTHER

No intervention administered

Non Interventional Study OTHER

Non Interventional Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with ALK-positive locally advanced or metastatic NSCLC

You may qualify if:

• Age: Patients aged 18 years or older;
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC
• Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).
• first-line loelaninab treatment fom Apr2023-Apr-2027.
• Evidenoe of popression to first-line lorlztinib within 2 weekes.

You may not qualify if:

• Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;
• Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Central Study Contacts

Li Zi ming

CONTACT

18017321562; liziming1980@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 1, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 11, 2025

Record last verified: 2025-03