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 %.
Phase Ib/II 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 %.
Centre Georges Francois Leclerc
24 participants
Jul 30, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Mirdametinib 4 mg twice/day for 7 days per cycle
For phase 2 : Randomisation with 2 arm : Standard arm and experimental arm
Mirdametinib 4 mg twice/day for 14 days per cycle
Mirdametinib 6 mg twice/day for 7 days per cycle
Mirdametinib 6 mg twice/day for 14 days per cycle
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05937906