RecruitingPhase 1Phase 2NCT05937906

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 %.


Sponsor

Centre Georges Francois Leclerc

Enrollment

24 participants

Start Date

Jul 30, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy, immunotherapy, and a short course of a targeted drug (MEK inhibitor) as a first-line treatment for advanced non-small cell lung cancer where the tumor has low levels of a protein called PD-L1. **You may be eligible if...** - You are 18 or older with advanced (metastatic) non-squamous non-small cell lung adenocarcinoma (a type of lung cancer) - Your tumor has PD-L1 expression less than 50% - Your tumor does not have EGFR or ALK gene mutations - You have not received prior chemotherapy or immunotherapy for this cancer - You are in good enough general health to tolerate treatment **You may NOT be eligible if...** - You have active brain metastases (cancer spread to the brain) that are untreated - You have autoimmune conditions requiring ongoing treatment - You have had prior treatment with MEK inhibitors or similar targeted therapies - You have certain heart conditions or other serious uncontrolled illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhase I - Mirdametinib - Level 1

Mirdametinib 4 mg twice/day for 7 days per cycle

DRUGPhase II - Mirdametinib

For phase 2 : Randomisation with 2 arm : Standard arm and experimental arm

DRUGPhase I - Mirdametinib - Level 2

Mirdametinib 4 mg twice/day for 14 days per cycle

DRUGPhase I - Mirdametinib - Level 3

Mirdametinib 6 mg twice/day for 7 days per cycle

DRUGPhase I - Mirdametinib - Level 4

Mirdametinib 6 mg twice/day for 14 days per cycle


Locations(1)

Centre Georges-François Leclerc

Dijon, Burgundy, France

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NCT05937906


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