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Kinase Inhibitor

Tepotinib for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A male participant must agree to use and to have their female partners of childbearing potential to use a highly effective contraception
Histologically or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types including squamous and sarcomatoid)
Must not have
Legal incapacity or limited legal capacity
Participants with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first treatment up to end of study (approximately month 101)
Awards & highlights

Summary

This trial will study the effects of tepotinib on lung cancer growth and spread, as well as safety, side effects, and quality of life. Pharmacogenetic research may also be conducted to study how genes impact the effectiveness of the drug.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that haven't had more than two prior treatments. They must have a certain gene alteration called METex14 and be in good physical condition (ECOG PS of 0 or 1). Women participating should not be pregnant or breastfeeding and must use effective contraception, as should men with female partners who could bear children.Check my eligibility
What is being tested?
The study tests the effectiveness of tepotinib, a drug aimed at stopping lung cancer growth and spread. It also examines how the body processes this drug, its safety profile, side effects, impact on quality of life, and includes optional genetic research to understand how genes affect drug response.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions where the medicine enters the body (infusion reactions), tiredness (fatigue), stomach issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use, and ensure my partner uses, effective birth control.
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My lung cancer is advanced and has been confirmed by lab tests.
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My cancer's size can be measured and has been confirmed by a review committee.
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My cancer has a specific genetic change called METex14.
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I have had no more than 2 previous treatments for my condition.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am legally unable to make my own decisions.
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My cancer has EGFR mutations sensitive to targeted therapy.
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My only measurable cancer is in my brain.
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I have been treated with drugs targeting the HGF/c-Met pathway before.
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My high blood pressure is not controlled below 150/90 mmHg despite treatment.
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I do not have HIV, hepatitis B, or hepatitis C.
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I haven't had cancer treatment except for palliative radiotherapy in the last 21 days.
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My blood, liver, kidney, or heart function is not normal.
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My cancer is sensitive to ALK-targeted therapy due to specific genetic changes.
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I have not had major surgery in the last 28 days.
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I don't have any lasting side effects from cancer treatment worse than Grade 1.
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I have brain metastases causing symptoms and affecting my neurological stability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first treatment up to end of study (approximately month 101)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first treatment up to end of study (approximately month 101) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Secondary outcome measures
Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
+11 more

Side effects data

From 2018 Phase 1 & 2 trial • 66 Patients • NCT02115373
75%
Oedema peripheral
50%
Alanine aminotransferase increased
50%
Blood alkaline phosphatase increased
50%
Abdominal pain
50%
Constipation
50%
Vomiting
25%
Lumbar vertebral fracture
25%
Blood creatinine increased
25%
Osteoporosis
25%
Blood bilirubin increased
25%
Amylase increased
25%
Dysphagia
25%
Eyelid oedema
25%
Aspartate aminotransferase increased
25%
Dysgeusia
25%
Migraine with aura
25%
Rib fracture
25%
Pyrexia
25%
Post procedural infection
25%
Decreased appetite
25%
Fatigue
25%
Gamma-glutamyltransferase increased
25%
Peripheral venous disease
25%
Pain in extremity
25%
Renal impairment
25%
Flank pain
25%
Acute kidney injury
25%
Epistaxis
25%
Lipase increased
25%
Disease progression
25%
Dry mouth
25%
Nausea
25%
Eructation
25%
Nasopharyngitis
25%
Weight decreased
25%
Back pain
25%
Musculoskeletal chest pain
25%
Papule
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1b: Tepotinib 300 mg
Phase 2: Tepotinib 500 mg
Phase 1b: Tepotinib 500 mg

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: Cohort C: Confirmatory Part for METex14 Skipping AlterationsExperimental Treatment1 Intervention
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Group II: Part 1: Cohort B: MET AmplificationExperimental Treatment1 Intervention
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Group III: Part 1: Cohort A: METex14 Skipping AlterationsExperimental Treatment1 Intervention
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tepotinib
2018
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
81 Previous Clinical Trials
30,628 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
439 Previous Clinical Trials
114,578 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
293 Previous Clinical Trials
69,027 Total Patients Enrolled

Media Library

Tepotinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02864992 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Part 1: Cohort A: METex14 Skipping Alterations, Part 1: Cohort B: MET Amplification, Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
Non-Small Cell Lung Cancer Clinical Trial 2023: Tepotinib Highlights & Side Effects. Trial Name: NCT02864992 — Phase 2
Tepotinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02864992 — Phase 2
~38 spots leftby Jul 2025