Actively Recruiting
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 %.
Led by Centre Georges Francois Leclerc · Updated on 2025-10-02
24
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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 %.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- Diagnosed with metastatic or locally advanced non-squamous non-small cell lung cancer
- No prior treatment for advanced or metastatic non-small cell lung cancer; prior adjuvant therapy allowed if completed over 12 months ago
- At least 18 years old
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months
- PD-L1 tumor proportion score below 50%
- At least one measurable tumor lesion suitable for repeated assessment
- Body weight over 30 kg
- Adequate heart function: QTc interval under 450 ms and left ventricular ejection fraction 50% or higher
- Willing and able to comply with study visits, treatments, and follow-up
- Affiliated with a social security system or beneficiary
- Tumor tissue available from recent biopsy (less than one month old) or fresh biopsy performed
- Willing to undergo mandatory fresh biopsies as required by the protocol
You will not qualify if you...
- Participation in another investigational clinical study within the last 2 months
- Concurrent enrollment in another interventional clinical study unless observational or in follow-up
- Presence of EGFR, ROS, or ALK targetable mutations
- Unresolved side effects grade 2 or higher from previous cancer treatments except certain exceptions
- Concurrent chemotherapy, investigational products, biologic, or hormonal cancer therapies
- Major surgery within 28 days before starting study treatment (exceptions apply)
- Gastrointestinal disorders affecting drug absorption
- History of organ or bone marrow transplant
- Active or prior autoimmune or inflammatory diseases with listed exceptions
- History of certain eye diseases or risk factors for retinal disorders
- Serious uncontrolled medical conditions or illnesses
- Use of medications known to prolong QT interval
- Resting ECG showing uncontrolled cardiac conditions
- Diagnosis or suspicion of myelodysplastic syndrome or acute myeloid leukemia
- History of other primary cancers unless treated and disease-free for 5 years
- History of leptomeningeal carcinomatosis
- Symptomatic central nervous system metastases
- Primary immunodeficiency or HIV infection
- Active infections including tuberculosis, hepatitis B, hepatitis C, or HIV (exceptions for resolved infections)
- Use of immunosuppressive medication within 14 days before first immunotherapy dose with specified exceptions
- Receipt of live vaccines within 30 days before first dose
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Known allergy or hypersensitivity to study drugs or their components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Georges-François Leclerc
Dijon, Burgundy, France, 21000
Actively Recruiting
Research Team
F
François FG GHIRINGHELLI, Professor
CONTACT
E
Emilie ER REDERSTORFF, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
6
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