drugset / Trial / NCT05937906

Clinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %.

NCT05937906

Phase 1/2 Recruiting 24 enrolled Centre Georges Francois Leclerc
Non-randomizedFactorialOpen-labelTreatment

Summary

Monocentric study composed by 2 steps : 1. First step is a phase I with the aim of establish the recommended dose of mirdametinib administration (2 or 4 mg twice a day for 7 or 14 days per cycle for the 4 first of carboplatin/pemetrexed/pembrolizumab treatment) 2. Second step is a non comparative randomized (2:1) phase II trial testing the recommended dose of mirdametinib administration. The aim is the efficacy and safety of short course of mirdametinib treatment for the 4 first cycles of the carboplatin/pemetrexed/pembrolizumab treatment.

Timeline

Start
2026-07-07
Primary completion
2028-07-25
Completion
2029-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirdametinib Small molecule 4 mg
Subject Mirdametinib Small molecule 6 mg