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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 %.

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Georges Francois Leclerc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Participation in another clinical study with an investigational product during the last 2 months

Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

Presence of EGFR, ROS or ALK targetable mutations

Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, ototoxicity, vitiligo, and the laboratory values defined in the inclusion criteria. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable before the first dose of study drug

Trial design

Design model

Factorial

Treatments tested in this trial

  • Phase I - Mirdametinib - Level 1

    Drug

    Mirdametinib 4 mg twice/day for 7 days per cycle

  • Phase II - Mirdametinib

    Drug

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

  • Phase I - Mirdametinib - Level 2

    Drug

    Mirdametinib 4 mg twice/day for 14 days per cycle

  • Phase I - Mirdametinib - Level 3

    Drug

    Mirdametinib 6 mg twice/day for 7 days per cycle

  • Phase I - Mirdametinib - Level 4

    Drug

    Mirdametinib 6 mg twice/day for 14 days per cycle

Treatment groups

24 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase I - Level 1Experimental treatment 1 intervention
Group B: Phase I - Level 2Experimental treatment 1 intervention
Group C: Phase I - Level 3Experimental treatment 1 intervention
Group D: Phase I - Level 4Experimental treatment 1 intervention
Group E: Phase II - Standard armNo intervention 0 interventions
Group F: Phase II - Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety will be evaluated using Dose Limiting Toxicities (DLT)

DLT is defined as any of the following toxicities occurring during the first 21 days after administration of the first dose. Adverse events (AEs) will be defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
Until progression, an average of 10 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Georges Francois Leclerc

Lead sponsor

Source ClinicalTrials.gov
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