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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 data cutoff (approximately month 66)

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first treatment up to data cutoff (approximately month 66)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from first treatment up to data cutoff (approximately month 66)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first treatment up to data cutoff (approximately month 66) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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)

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%

Flank pain

25%

Amylase increased

25%

Eyelid oedema

25%

Blood bilirubin increased

25%

Aspartate aminotransferase increased

25%

Osteoporosis

25%

Post procedural infection

25%

Decreased appetite

25%

Dysphagia

25%

Fatigue

25%

Pyrexia

25%

Rib fracture

25%

Lumbar vertebral fracture

25%

Blood creatinine increased

25%

Gamma-glutamyltransferase increased

25%

Pain in extremity

25%

Dysgeusia

25%

Migraine with aura

25%

Renal impairment

25%

Peripheral venous disease

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%

Study treatment Arm

Phase 1b: Tepotinib 300 mg

Phase 2: Tepotinib 500 mg

Phase 1b: Tepotinib 500 mg

Awards & Highlights

No Placebo-Only Group

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

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

0 / 19Eligibility criteria met