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 %.
| NCT ID | NCT05937906 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Centre Georges Francois Leclerc |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2028-05-25 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. * Patients must be diagnosed with a metastatic or locally advanced non squamous non-small cell lung cancer * 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 * Age \>18 years at time of study entry * Performance status ECOG of 0 or 1 * Life expectancy ≥ 6 months * PD-L1\<50% using TPS scoring * At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) that can be accurately assessed at baseline and is suitable for repeated assessment * Body weight
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