drugset / Trial / NCT04111705

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

NCT04111705

Phase 2 Completed 23 enrolled French Cooperative Thoracic Intergroup
NaSingle-groupOpen-labelTreatment

Summary

Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.

Timeline

Start
2020-08-05
Primary completion
2022-08-11
Completion
2024-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Lorlatinib Small molecule 100 mg