What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) that target pathways similar to Merestinib, such as MET and NTRK inhibitors, often include side effects like fatigue, nausea, increased liver function tests, and gastrointestinal issues such as diarrhea. Additionally, targeted therapies can cause specific adverse events like rash and anorexia. In some cases, more severe side effects such as pulmonary hemorrhage and cardiac issues have been reported. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

For the treatment of Non-Small Cell Lung Cancer (NSCLC), the FDA has approved several targeted therapies. Crizotinib is an ALK and MET inhibitor used for patients with MET exon 14 mutations. Additionally, larotrectinib and entrectinib are approved for tumors with NTRK gene fusions, which are rare but can occur in NSCLC. These drugs are similar to Merestinib, which also targets MET and NTRK pathways. Other notable FDA-approved treatments for NSCLC include pembrolizumab and atezolizumab, which are immune checkpoint inhibitors used in various settings of NSCLC.

What other types of research exist?

Promising alternatives to Merestinib for NSCLC patients include Entrectinib, which is effective for ROS1- or NTRK-rearranged NSCLC, and selective RET inhibitors like Selpercatinib and Pralsetinib for RET-mutated tumors. Additionally, the combination of Dabrafenib and Trametinib is approved for BRAF V600E mutations, and Pyrotinib has shown efficacy in HER2-mutant NSCLC.

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Small Molecule Inhibitor

Merestinib for Non-Small Cell Lung Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeted therapies that inhibit specific molecular pathways critical for tumor growth and survival. For instance, Merestinib targets the MET and NTRK pathways. MET inhibitors block the MET receptor tyrosine kinase, which is involved in cell proliferation, survival, and metastasis. NTRK inhibitors target the neurotrophic receptor tyrosine kinase, which, when altered, can drive cancer growth. These targeted therapies are crucial for NSCLC patients as they offer a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy. By specifically targeting the molecular abnormalities in cancer cells, these treatments can effectively halt tumor progression and improve patient prognosis.

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).

Must not have

Participants with uncontrolled high blood pressure, defined as a blood pressure during screening of ≥ 160/100 despite medical management.

Known HIV-positive participants are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease was evaluated at cycle 2 day 28 and at the end of every 2 cycles thereafter and in long-term survival followed-up every 3 months. median follow-up for survival is of 24.28 months with range (0.46 months - 32.13 months).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing merestinib, a drug that blocks proteins helping cancer cells grow, in patients with advanced NSCLC with a MET mutation or solid tumors with NTRK changes. These patients are targeted because their cancers have specific genetic changes that might not respond to usual treatments. Merestinib has shown effectiveness in blocking tumor growth in various types of tumors.

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.

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.

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 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 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 swallow pills or have a feeding tube for medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not controlled, even with medication.

Select...

I do not have HIV.

Select...

I do not have any serious illnesses that would stop me from following the study's requirements.

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ survival data collection in long-term follow-up every 3 months. median follow-up for survival is of 24.28 months with range (0.46 months - 32.13 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~survival data collection in long-term follow-up every 3 months. median follow-up for survival is of 24.28 months with range (0.46 months - 32.13 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and survival data collection in long-term follow-up every 3 months. median follow-up for survival is of 24.28 months with range (0.46 months - 32.13 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR) - MET Exon 14 Cohort

Secondary study objectives

Grade 4-5 Treatment-related Toxicity Rate

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

Median Overall Survival (OS) - MET Exon 14 Cohort

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~250

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeted therapies that inhibit specific molecular pathways critical for tumor growth and survival. For instance, Merestinib targets the MET and NTRK pathways. MET inhibitors block the MET receptor tyrosine kinase, which is involved in cell proliferation, survival, and metastasis. NTRK inhibitors target the neurotrophic receptor tyrosine kinase, which, when altered, can drive cancer growth. These targeted therapies are crucial for NSCLC patients as they offer a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy. By specifically targeting the molecular abnormalities in cancer cells, these treatments can effectively halt tumor progression and improve patient prognosis.