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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
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jul 30, 2024 to Jul 7, 2026 Primary completion date: May 25, 2028 to Jul 25, 2028 · Completion date: May 25, 2028 to May 25, 2029v7 Show 2 more changesShow less
    • Primary completion date: May 25, 2028 to Jul 25, 2028
    • Completion date: May 25, 2028 to May 25, 2029
  2. 2 versions Re-verified since Jun 27, 2025, no change to tracked fieldsv5-v6
  3. Eligibility criteria expanded, about 1 wordv4 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2024 to Jul 30, 2024 · Study sites: 0 to 1 · Primary and study completion dates: Apr 1, 2029 to May 25, 2028 · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2024 to Jul 30, 2024
    • Study sites: 0 to 1
    • Primary and study completion dates: Apr 1, 2029 to May 25, 2028
    • Eligibility criteria expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: Sep 1, 2028 to Apr 1, 2029 Start date: Sep 1, 2023 to Apr 1, 2024v2 Show 1 more changeShow less
    • Start date: Sep 1, 2023 to Apr 1, 2024
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05937906
Lead Sponsor Centre Georges Francois Leclerc
Conditions Non-Small Cell Lung Cancer
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov