A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib

This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.

NCT Number	NCT06378892
Lead Sponsor	Centro di Riferimento Oncologico - Aviano
Conditions	Non Small Cell Lung Cancer Metastatic, ALK Gene Mutation
Enrollment	45 participants
Start Date	2024-03-15
Primary Completion	2028-05 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2024-04-23