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NCT05937906Not yet 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 %.

Phase Ib/II 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 %.
Centre Georges Francois LeclercPhase 1/2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Non-Small Cell Lung Cancer
Drug/Device/Intervention
Phase I - Mirdametinib - Level 1
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Centre Georges Francois Leclerc
Timeline & enrollment
Phase
Phase 1/2
Start date
Sep 01, 2023
End date
Sep 01, 2028
Enrollment
24 participants
Primary outcome

Safety will be evaluated using Dose Limiting Toxicities (DLT)

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.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05937906
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05937906 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Centre Georges Francois Leclerc and is currently Not yet recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.