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
Study ID
NCT05937906
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 10, 2023
Start date
Jul 7, 2026
Status verified
Jul 2026
Primary completion
Jul 25, 2028
Completion
May 25, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I - Level 1
    Mirdametinib 4 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients
  • Experimental: Phase I - Level 2
    Mirdametinib 4 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients
  • Experimental: Phase I - Level 3
    Mirdametinib 6 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients
  • Experimental: Phase I - Level 4
    Mirdametinib 6 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients
  • No Intervention: Phase II - Standard arm
    Carboplatin / Pemetrexed / Pembrolizumab for the first 4 cycles
  • Experimental: Phase II - Experimental arm
    Carboplatin / Pemetrexed / Pembrolizumab + mirdametinib for the first 4 cycles

Primary Outcome Measure

Safety will be evaluated using Dose Limiting Toxicities (DLT) [ Time Frame: Until progression, an average of 10 months ]

Central Contacts

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