Phase II Study of Platinum-pemetrexed Chemotherapy Combined with Lorlatinib in Adults with ALK Positive Non-Small Cell Lung Cancer With Disease Progression Outside the Brain on Lorlatinib

What this Trial Is About

Researchers are evaluating the activity and safety of combining platinum-pemetrexed based chemotherapy with Lorlatinib in patients who have ALK positive Non-Small Cell Lung Cancer NSCLC that has progressed only outside the brain while on Lorlatinib treatment. This phase II, multicenter, single-arm study focuses on patients with extracranial progression despite Lorlatinib, aiming to understand how this combination may affect progression and survival. Treatment begins with an induction phase of four cycles using Lorlatinib plus either Carboplatin or Cisplatin and Pemetrexed chemotherapy. After this, patients who show disease response or stability based on imaging scans enter a maintenance phase where they receive pemetrexed and Lorlatinib every 21 days. This maintenance continues until disease progression, unacceptable side effects, death, or withdrawal from the study. Participants will undergo regular assessments including CT and MRI scans to measure tumor response and monitor for progression. Researchers will evaluate progression-free survival as the primary outcome, along with intracranial progression-free survival, overall survival, and safety over up to 60 months. The study includes monitoring organ functions and treatment tolerability throughout the induction and maintenance phases, with continuous follow-up until the study ends or participants leave.

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