RecruitingPhase I/IIEN originalLung cancerMetastatic / advanced

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 %.

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Rozpoznanie zaawansowanego raka płuc (typu non-squamous non-small cell)
  • Wiek powyżej 18 lat
  • Brak wcześniejszego leczenia tego typu raka (chemioterapia adjuwantna możliwa powyżej 12 miesięcy)
  • Dobra ogólna kondycja zdrowotna (status ECOG 0 lub 1)
  • Spodziewana długość życia co najmniej 6 miesięcy
  • Wynik testu PD-L1 poniżej 50%
  • Możliwość zobaczenia nowotworu na badaniach obrazowych (tomografia, rezonans)
  • Waga powyżej 30 kg

✗ Disqualifies

  • Zaburzenia rytmu serca lub problemy z funkcją serca
  • Niezadowalające funkcje wątroby, nerek lub szpiku kostnego
  • Przedłużony QTc na elektrokardiogramie (powyżej 450 ms)
  • Skrócona spodziewana długość życia poniżej 6 miesięcy

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 9, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Centre Georges-François Leclerc

Dijon, France

Trial contact

François FG GHIRINGHELLI, Professor

Emilie ER REDERSTORFF, Project manager

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.

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