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Tests treatment safety and results for Non-Small Cell Lung Cancer
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 %.
ClinicalTrials.gov ID: NCT05937906
What this study is testing
What is Phase I - Mirdametinib - Level 1?
Phase I - Mirdametinib - Level 1 is an investigational medicine, given as a twice-daily, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- 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...
- Age \>18 years at time of study entry
- Performance status ECOG of 0 or 1
You likely can't join if
- 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-treatment) clinical study or during the follow-up period of an...
- 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...
- Major surgical procedure within 28 days prior to therapy initiation IP. Note: Local surgery of isolated lesions for palliative intent is acceptable...
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases...
See the full eligibility criteria
Who can join
- 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...
- 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 \>30 kg
- Adequate normal organ and marrow function as defined below:
- Adequate cardiac function: (QTc \< 450 msec on baseline ECG, using the Fridericia correction cQTcF formula) or other clinically significant ventricular or atrial arrhythmia. Left ventricular ejection fraction (LVEF) ≥...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Patient affiliated to a social security regimen or beneficiary of the same according
- Validation of the quality and quantity of the tumoral material at inclusion (existing material dated less than one month and/or fresh biopsy).
- Patient is willing to perform the fresh biopsies mandatory for the protocol: Phase I: A mandatory fresh biopsy of 4 samples at inclusion and after Cycle 2 (betweenC2J7 and C2J14) Phase II: A mandatory fresh biopsy. of 4...
What rules you out
- 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-treatment) clinical study or during the follow-up period of an treatment 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...
- Major surgical procedure within 28 days prior to therapy initiation IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy...
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea or malabsorption syndrome).
- History of allogenic organ, bone marrow or double umbilical cord blood transplantation
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- History of glaucoma, any retinal pathology considered to be a risk factor for central serous retinopathy, retinal vein occlusion (RVO) or neovascular macular degeneration. Also, any risk factors for RVO as intraocular...
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease. Any uncontrolled intercurrent illness, including but not limited to, ongoing or active infection...
- Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, cQTcF prolongation...
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML
- History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence Adequately treated...
- History of leptomeningeal carcinomatosis
- Patient with symptomatic central nervous system (CNS) metastases
- History of active primary immunodeficiency or Immunocompromised patients e.g, patients who are known to be serologically positive for human immunodeficiency virus (HIV)
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV...
- Current or prior use of immunosuppressive medication within 14 days before the first dose of immunotherapy. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid...
- Receipt of live or live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine (yellow fever vaccination is forbidden) whilst receiving IP and up to...
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of treatment...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipients
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, Burgundy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, Burgundy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.