Clinical Trial

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 %.

Study acronym: IMMUNOMEK
Recruiting Phase 1/2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-07-07; most recent amendment 2026-07-07.
Status change: Not Yet Recruiting → Recruiting 2025-02-14
Trial Details
NCT Number NCT05937906
Lead Sponsor Centre Georges Francois Leclerc
Conditions Non-Small Cell Lung Cancer
Enrollment 24 participants
Start Date 2026-07-07
Primary Completion 2028-07-25 (estimated)
Study Completion 2029-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-09