Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

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Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Merestinib at the recommended phase II dose of 120 mg by mouth daily.

Merestinib is a potent and selective type II MET/RON kinase inhibitor with the ability to achieve inhibition of MET activity both in vitro and in vivo.

Merestinib

Mark Awad, MD

This research study is examining merestinib (a targeted therapy) as a possible treatment for non-small cell lung cancer (NSCLC) that was found to have a specific change in the MET gene (a MET exon 14 mutation); or as a treatment for solid tumors that have an alteration in the NTRK gene (an NTRK1, 2, or 3 rearrangement).

This is an open-label, phase II study of merestinib in patients with advanced NSCLC with a MET exon 14 mutation or patients with advanced cancer harboring an NTRK1, 2, or 3 rearrangement. Twenty patients with a MET mutation will be evaluated in a single-arm design. A small separate cohort of 5 NTRK patients will be evaluated for exploratory purposes.

Merestinib (LY2801653) is a small molecule that has been shown in vitro to be a reversible type II ATP-competitive inhibitor of MET. Pre-clinical testing also has shown merestinib to inhibit several other receptor tyrosine oncokinases including MST1R, FLT3, AXL, MERTK, TEK, ROS1, NTRK1/2/3, and DDR1/2 and the serine/threonine kinases MKNK1/2.

Merestinib In Non-Small Cell Lung Cancer And Solid Tumors

A Phase II Study of Merestinib in Non-Small Cell Lung Cancers Harboring MET Exon 14 Mutations and Solid Tumors With NTRK Rearrangements

ORR was defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment in MET Exon 14 Cohort based on RECISTv1.1 criteria.

OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per RECIST 1.1 criteria. or death, or is censored at time of last disease assessment.

DOR, estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per RECISTv1.1, until the first date that recurrent or progressive disease is objectively documented. Patients without PD are censored at the date of last disease assessment.

All grade 4-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.

Eli Lilly and Company

Dana-Farber Cancer Institute

Principal Investigator

Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Merestinib: Oral, predetermined dosage of 120mg per protocol, once daily per 28 day treatment cycle

NSCLC (Met Exon 14 Mutation)

Solid Tumor (NTRK1,2,3 Rearrangement)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

No patient was accrued in the solid tumor arm.

Mark Awad, MD, PhD

The analysis population is comprised of eligible and treated patients.

Overall Response Rate (ORR) - MET Exon 14 Cohort

Median Overall Survival (OS) - MET Exon 14 Cohort

The analysis population is comprised of all eligible and treated patients.

Median Progression-free Survival (PFS) - MET Exon 14 Cohort

This analysis dataset is comprised of all patients who had a CR or PR on treatment.

Median Duration of Response (DOR) - MET Exon 14 Cohort

This analysis dataset is comprised of all eligible and treated patients.

Grade 4-5 Treatment-related Toxicity Rate

Merestinib: Oral, predetermined dosage of 120 mg per protocol, once daily per 28 day treatment cycle

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Methotrexate

Tepotinib

Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Ki Hyeong Lee, M.D.

Eun Joo Kang, M.D.

Soon Il Lee

Yu Jeong Kim

Yun Ji Choe

The aim of this study is to understand efficacy of tepotinib in patients with solid cancers harbouring c-MET amplification or exon 14 mutation who progressed after standard treatment for metastatic disease.

This study is a basket trial with two strata(NSCLC and other cancer). If MET exon 14 skipping mutation or MET amplification(copy number gain ≥6.0 ) is detected by NGS method, then confirmation of genetic findings by Molecular Steering Committee will be followed. Patient can participate in this trial after confirmation of genetic analysis and reviewing other inclusion/exclusion criteria.

Experimental: Arm 1_NSCLC Patients with non-small cell lung cancer (NSCLC) harboring MET alteration Experimental: Arm 2_Other solid tumors Solid tumors excluding NSCLC harboring MET alteration

Tepotinib in Solid Tumors Harboring MET Alterations

A Phase II Study of Tepotinib in Patients With Solid Cancers Harboring c-MET Amplification or Exon 14 Mutation Who Progressed After Standard Treatment for Advanced/Metastatic Disease

Objective response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator.

Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Progression free survival as assessed by investigators is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (based on independent review) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first

Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions.

Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.

This outcome measure will be presented as the percentage of subjects with any adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Merestinib In Non-Small Cell Lung Cancer And Solid Tumors	NCT02920996	Carcinoma, Non-... Solid Tumor	Merestinib	18 Years -	Dana-Farber Cancer Institute
Merestinib In Non-Small Cell Lung Cancer And Solid Tumors	NCT02920996	Carcinoma, Non-... Solid Tumor	Merestinib	18 Years -	Dana-Farber Cancer Institute
Tepotinib in Solid Tumors Harboring MET Alterations	NCT04647838	Solid Tumor MET Exon 14 Ski... MET Amplificati...	Tepotinib	19 Years -	Chungbuk National University Hospital

Spots Global Cancer Trial Database for met exon 14

Every month we try and update this database with for met exon 14 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for met exon 14

Every month we try and update this database with for met exon 14 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for met exon 14 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.