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Small Molecule Inhibitor

Merestinib for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Mark Awad, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
ECOG performance status ≤ 1 (see Appendix A).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing merestinib as a possible treatment for NSCLC with a specific MET gene change or for solid tumors with an NTRK gene alteration.

Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) having a MET gene mutation, or solid tumors with an NTRK gene alteration. Participants must have tried at least one other treatment, be able to perform daily activities mostly without help (ECOG ≤ 1), and have normal organ function. Pregnant women are excluded; others must use contraception. Prior MET or NTRK inhibitor-treated patients need to consent to a biopsy.Check my eligibility
What is being tested?
The trial is testing merestinib, which targets specific genetic changes in cancer cells: the MET exon 14 mutation in NSCLC and alterations in the NTRK gene for solid tumors. It aims to see if this drug can effectively treat these cancers when standard treatments haven't worked.See study design
What are the potential side effects?
Merestinib's side effects aren't fully known but may include risks similar to other MET inhibitors such as nausea, fatigue, swelling due to fluid retention, shortness of breath, and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can carry out all my self-care activities without help.
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I have had NTRK inhibitor treatment and agree to a tumor biopsy.
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I have not taken any TKI medication for a period long enough since my last dose.
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I have a tumor that can be measured with scans or exams.
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My cancer has an NTRK gene change confirmed by a specific test.
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I agree to use birth control during and up to 4 months after the study.
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I am 18 years old or older.
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I have an advanced solid tumor and have been treated for it before.
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I can carry out all my self-care but cannot do heavy physical work.
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My organ and bone marrow functions are normal.
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I can swallow pills or have a feeding tube for medication.
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I have advanced NSCLC and have undergone at least one treatment for it.
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My cancer has a MET exon 14 mutation confirmed by a specific genetic test.
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I have had MET inhibitor treatment and agree to a tumor biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) - MET Exon 14 Cohort
Secondary outcome measures
Duration of response (DoR) - MET Exon 14 Cohort
Overall Survival (OS) Rate - MET Exon 14 Cohort
Progression-free survival (PFS) Rate - MET Exon 14 Cohort
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Solid Tumor (NTRK1,2,3 Rearrangement)Experimental Treatment1 Intervention
Merestinib at the recommended phase II dose of 120 mg by mouth daily.
Group II: NSCLC (Met Exon 14 Mutation)Experimental Treatment1 Intervention
Merestinib at the recommended phase II dose of 120 mg by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Merestinib
2017
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,394 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,658 Total Patients Enrolled
Mark Awad, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Merestinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02920996 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: NSCLC (Met Exon 14 Mutation), Solid Tumor (NTRK1,2,3 Rearrangement)
Non-Small Cell Lung Cancer Clinical Trial 2023: Merestinib Highlights & Side Effects. Trial Name: NCT02920996 — Phase 2
Merestinib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02920996 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for people who want to participate in this research?

"This study, which was published on clinicaltrials.gov on November 11th 2016 and last updated on August 22nd 2022, is no longer recruiting patients. There are 2410 other trials that are currently open for enrollment."

Answered by AI

Could you please detail the risks associated with Merestinib?

"Merestinib's safety is estimated to be a 2. This is because, while there is data suggesting that it is safe, there is no evidence yet of its efficacy."

Answered by AI

If so, could you please detail the findings of prior Merestinib clinical trials?

"At this time, there are 3 ongoing clinical trials assessing Merestinib's efficacy and 0 of these studies have reached Phase 3. The majority of the research is being conducted in San Antonio, Texas; however, there are a total of 104 locations running Merestinib clinical trials."

Answered by AI

Does this research represent a new frontier for treatments?

"Research into merestinib started in 2016 with a clinical trial conducted by Eli Lilly and Company. After the initial study involving 309 people, merestinib received Phase 2 drug approval in [year]. As of now, there are 3 active studies being done for Merestinib across 18 cities and 20 countries."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby Mar 2025