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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 %.

NCT05937906 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Phase I - Mirdametinib - Level 1

Mirdametinib 4 mg twice/day for 7 days per cycle

DRUG

Phase II - Mirdametinib

For phase 2 : Randomisation with 2 arm : Standard arm and experimental arm

DRUG

Phase I - Mirdametinib - Level 2

Mirdametinib 4 mg twice/day for 14 days per cycle

DRUG

Phase I - Mirdametinib - Level 3

Mirdametinib 6 mg twice/day for 7 days per cycle

DRUG

Phase I - Mirdametinib - Level 4

Mirdametinib 6 mg twice/day for 14 days per cycle

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2028-05-25
Completion
2028-05-25

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937906 on ClinicalTrials.gov