Non-Small Cell Lung CancerPhase 1/2IMMUNOMEKNCT05937906
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 %.
A Phase 1/2 study testing Phase I - Mirdametinib - Level 1, Phase II - Mirdametinib and Phase I - Mirdametinib - Level 2 in people with Non-Small Cell Lung Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Phase I - Mirdametinib - Level 1, Phase II - Mirdametinib and Phase I - Mirdametinib - Level 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2026to 25 May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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
Show all 18Show fewer
- 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) ≥ 50%
- 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 samples at inclusion. Second biopsy at 4-5 weeks after treatment initiation is optional.
Who cannot join
- 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
- 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, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of study drug
- 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).
Show all 24Show fewer
- 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 erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the study physician Patients with celiac disease controlled by diet alone
- 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 pressure (IOP) >21, uncontrolled blood glucose
- 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, symptomatic congestive heart failure (including history of myocardial infarction within 3 months, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or any cardiac arrhythmias, e.g, ventricular, supraventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening) uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high Resolution Computed Tomography (HRCT) sacan or any psychiatric disorder that prohibits obtaining informed consent.
- 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 >450ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome
- 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 non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease
- 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 surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- 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 injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- 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 30 days after the last dose of IP.
- 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. (Contraceptive requirements: Male patients must use a condom during treatment and for 3 months after the last dose when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.)
- Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Georges-François Leclerc
Dijon, Burgundy, 21000
François GHIRINGHELLI, Pr, 03 80 73 75 00, fghiringhelli@cgfl.fr
Emilie REDERSTORFF, 03 45 34 81 16, erederstorff@cgfl.fr
About this study
Official title: 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 %.
Monocentric study composed by 2 steps :
- 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)
- 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.
Read the detailed description
- Phase I (15-24 patients) Using a classical "3+3 design": The phase I will included a maximum 24 patients. 3 patients will be included in dose level 1, if not DLT occurs 3 patients will be included in level 2. If 1 DLT occurs 3 additional patients will be included; if 2 or more DLT occurs the trial will be stopped. At level 2 if no DLT occurs RP2D 3 patients will be included at level 3; If 1 DLT occurs 3 additional patients will be included; if 2 or more DLT occurs RP2D will be level 1. Similar rules will be applied for level 3 and 4. In absence of DLT CXCL10 and PD-L1, CD8 immune infiltrates and immunoscore IC (CD8-PDL1 dual markers) at baseline and 6 weeks, and clinical efficacy will be presented to IDMC for definition of RP2D. At the end of phase I inclusion toxicity, efficacy data and biological data (CXCL10 seric and IHC expression and PD-L1, CD8 immune infiltrates and immunoscore IC (CD8-PDL1 dual markers) at baseline and 6 weeks, PK and PK/PD data will be presented to IDMC to validate RP2D.
- 3 +/- 3 patients for level 1 (mirdametinib 4 mg twice/ 7 days)
- 3 +/- 3 patients for level 2 (mirdametinib 4 mg twice/ 14 days)
- 3 +/- 3 patients for level 3 (mirdametinib 6 mg twice/ 7 days)
- 3 +/- 3 patients for level 4 (mirdametinib 6 mg twice/ 14 days)
PHASE II (78 patients) Sample size calculation was performed using PASS v13. In keynote 189 response rate in PD-L1 <50% was 40% (28). A 3-month overall response rate (ORR) of 40% is considered unacceptable (P0=40%). The study team expect an ORR of 55% in the experiment arm (P1=55%, acceptable ORR).
Using a single stage design (A Hern, exact test) with unilateral α=10%, power=80%, 50 patients are needed for the primary endpoint analysis in the experimental arm. With 5% of non-evaluable patients, 52 patients will be included in this arm. With a 2:1 randomization the control arm will include 26 patients. A total of 78 subjects are then needed in the phase 2 part.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Phase I - Mirdametinib - Level 1, Phase II - Mirdametinib, Phase I - Mirdametinib - Level 2, Phase I - Mirdametinib - Level 3, Phase I - Mirdametinib - Level 4
- Keywords
- locally advanced or metastatic, non squamous non small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I - Mirdametinib - Level 1Drug
Mirdametinib 4 mg twice/day for 7 days per cycle
Phase II - MirdametinibDrug
For phase 2 : Randomisation with 2 arm : Standard arm and experimental arm
Phase I - Mirdametinib - Level 2Drug
Mirdametinib 4 mg twice/day for 14 days per cycle
Phase I - Mirdametinib - Level 3Drug
Mirdametinib 6 mg twice/day for 7 days per cycle
Phase I - Mirdametinib - Level 4Drug
Mirdametinib 6 mg twice/day for 14 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Level 1 | Experimental | Mirdametinib 4 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab.
Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients Receives: Drug: Phase I - Mirdametinib - Level 1 |
| Phase I - Level 2 | Experimental | Mirdametinib 4 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab.
Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients Receives: Drug: Phase I - Mirdametinib - Level 2 |
| Phase I - Level 3 | Experimental | Mirdametinib 6 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab.
Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients Receives: Drug: Phase I - Mirdametinib - Level 3 |
| Phase I - Level 4 | Experimental | Mirdametinib 6 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab.
Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients Receives: Drug: Phase I - Mirdametinib - Level 4 |
| Phase II - Standard arm | No intervention | Carboplatin / Pemetrexed / Pembrolizumab for the first 4 cycles |
| Phase II - Experimental arm | Experimental | Carboplatin / Pemetrexed / Pembrolizumab + mirdametinib for the first 4 cycles Receives: Drug: Phase II - Mirdametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until progression, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start7 Jul 2026 (estimated)
- Primary completion25 Jul 2028 (estimated)
- Study completion25 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Phase 1 (escalation dose) * Level 1: mirdametinib 4 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) * Level 2: mirdametinib 4 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) * Level 3: mirdametinib 6 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) * Level 4: mirdametinib 6 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) Phase 2 (randomized) * Standard arm : Carboplatin/pemetrexed/pembrolizumab for the first 4 cycles until progression (26 patients) * Experimental arm : Carboplatin/pemetrexed/pembrolizumab + mirdametinib for the first 4 cycles until progression (52 patients)
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937906
- Sponsor's protocol ID
- 2023-508477-87-00
- Other IDs
- 2023
- Acronym
- IMMUNOMEK
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 %.
- ClinicalTrials.gov ID
- NCT05937906
- Acronym / sponsor ID
- IMMUNOMEK / 2023-508477-87-00
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- locally advanced or metastatic, non squamous non small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 25 Jul 2028 (estimated)
- Study completion
- 25 May 2029 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monocentric study composed by 2 steps :
- 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)
- 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.
Detailed description
- Phase I (15-24 patients) Using a classical "3+3 design": The phase I will included a maximum 24 patients. 3 patients will be included in dose level 1, if not DLT occurs 3 patients will be included in level 2. If 1 DLT occurs 3 additional patients will be included; if 2 or more DLT occurs the trial will be stopped. At level 2 if no DLT occurs RP2D 3 patients will be included at level 3; If 1 DLT occurs 3 additional patients will be included; if 2 or more DLT occurs RP2D will be level 1. Similar rules will be applied for level 3 and 4. In absence of DLT CXCL10 and PD-L1, CD8 immune infiltrates and immunoscore IC (CD8-PDL1 dual markers) at baseline and 6 weeks, and clinical efficacy will be presented to IDMC for definition of RP2D. At the end of phase I inclusion toxicity, efficacy data and biological data (CXCL10 seric and IHC expression and PD-L1, CD8 immune infiltrates and immunoscore IC (CD8-PDL1 dual markers) at baseline and 6 weeks, PK and PK/PD data will be presented to IDMC to validate RP2D.
- 3 +/- 3 patients for level 1 (mirdametinib 4 mg twice/ 7 days)
- 3 +/- 3 patients for level 2 (mirdametinib 4 mg twice/ 14 days)
- 3 +/- 3 patients for level 3 (mirdametinib 6 mg twice/ 7 days)
- 3 +/- 3 patients for level 4 (mirdametinib 6 mg twice/ 14 days)
PHASE II (78 patients) Sample size calculation was performed using PASS v13. In keynote 189 response rate in PD-L1 <50% was 40% (28). A 3-month overall response rate (ORR) of 40% is considered unacceptable (P0=40%). The study team expect an ORR of 55% in the experiment arm (P1=55%, acceptable ORR).
Using a single stage design (A Hern, exact test) with unilateral α=10%, power=80%, 50 patients are needed for the primary endpoint analysis in the experimental arm. With 5% of non-evaluable patients, 52 patients will be included in this arm. With a 2:1 randomization the control arm will include 26 patients. A total of 78 subjects are then needed in the phase 2 part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Phase 1 (escalation dose) * Level 1: mirdametinib 4 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) * Level 2: mirdametinib 4 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) * Level 3: mirdametinib 6 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) * Level 4: mirdametinib 6 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab until progression (3-6 patients) Phase 2 (randomized) * Standard arm : Carboplatin/pemetrexed/pembrolizumab for the first 4 cycles until progression (26 patients) * Experimental arm : Carboplatin/pemetrexed/pembrolizumab + mirdametinib for the first 4 cycles until progression (52 patients)
| Arm | Type | Receives |
|---|---|---|
| Phase I - Level 1 | Experimental | Drug: Phase I - Mirdametinib - Level 1Mirdametinib 4 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients |
| Phase I - Level 2 | Experimental | Drug: Phase I - Mirdametinib - Level 2Mirdametinib 4 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients |
| Phase I - Level 3 | Experimental | Drug: Phase I - Mirdametinib - Level 3Mirdametinib 6 mg twice/day for 7 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients |
| Phase I - Level 4 | Experimental | Drug: Phase I - Mirdametinib - Level 4Mirdametinib 6 mg twice/day for 14 days per cycle for the 4 first cycles + carboplatin/pemetrexed/pembrolizumab. Pemetrexed/pembrolizumab until progression Number of participants : 3 to 6 patients |
| Phase II - Standard arm | No intervention | –Carboplatin / Pemetrexed / Pembrolizumab for the first 4 cycles |
| Phase II - Experimental arm | Experimental | Drug: Phase II - MirdametinibCarboplatin / Pemetrexed / Pembrolizumab + mirdametinib for the first 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (24 listed)
- 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
- 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, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase I - Mirdametinib - Level 1Mirdametinib 4 mg twice/day for 7 days per cycle | Drug | Phase I - Level 1 |
| Phase II - MirdametinibFor phase 2 : Randomisation with 2 arm : Standard arm and experimental arm | Drug | Phase II - Experimental arm |
| Phase I - Mirdametinib - Level 2Mirdametinib 4 mg twice/day for 14 days per cycle | Drug | Phase I - Level 2 |
| Phase I - Mirdametinib - Level 3Mirdametinib 6 mg twice/day for 7 days per cycle | Drug | Phase I - Level 3 |
| Phase I - Mirdametinib - Level 4Mirdametinib 6 mg twice/day for 14 days per cycle | Drug | Phase I - Level 4 |
Primary outcome
Safety will be evaluated using Dose Limiting Toxicities (DLT)
Time frame: Until progression, an average of 10 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phase I - Mirdametinib - Level 1, Phase II - Mirdametinib and Phase I - Mirdametinib - Level 2 in people with Non-Small Cell Lung Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François FG GHIRINGHELLI, Professor (0380737776, fghiringhelli@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be evaluated using Dose Limiting Toxicities (DLT) (time frame: Until progression, an average of 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.