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OncoMatch/Clinical Trials/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 %.

Is NCT05937906 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for non-small cell lung cancer.

Phase 1/2RecruitingCentre Georges Francois LeclercNCT05937906Data as of May 2026

Treatment: Phase I - Mirdametinib - Level 1 · Phase II - Mirdametinib · Phase I - Mirdametinib - Level 2 · Phase I - Mirdametinib - Level 3 · Phase I - Mirdametinib - Level 4Monocentric 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR targetable mutation

Presence of EGFR, ROS or ALK targetable mutations [excluded]

Required: ALK targetable mutation

Presence of EGFR, ROS or ALK targetable mutations [excluded]

Required: ROS1 targetable mutation

Presence of EGFR, ROS or ALK targetable mutations [excluded]

Required: PD-L1 (CD274) expression < 50% (TPS) (< 50%)

PD-L1<50% using TPS scoring

Disease stage

Metastatic disease required

Patients must be diagnosed with a metastatic or locally advanced non squamous non-small cell lung cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Exception: Previous adjuvant therapy is allowed if > 12 months from the last injection

Absence of previous treatment for or locally advanced or metastatic non-small cell lung cancer. Previous adjuvant therapy is allowed if > 12 months from the last injection

Lab requirements

Blood counts

Adequate normal organ and marrow function as defined below

Kidney function

Adequate normal organ and marrow function as defined below

Liver function

Adequate normal organ and marrow function as defined below

Cardiac function

QTc < 450 msec on baseline ECG (Fridericia correction cQTcF); LVEF ≥ 50%

Adequate normal organ and marrow function as defined below: Adequate cardiac function: (QTc < 450 msec on baseline ECG, using the Fridericia correction cQTcF formula) or other clinically significant ventricular or atrial arrhythmia. Left ventricular ejection fraction (LVEF) ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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