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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from first treatment up to end of study (approximately month 101)

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first treatment up to end of study (approximately month 101)

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%

Dysgeusia

25%

Osteoporosis

25%

Migraine with aura

25%

Lumbar vertebral fracture

25%

Rib fracture

25%

Aspartate aminotransferase increased

25%

Blood creatinine increased

25%

Dysphagia

25%

Eyelid oedema

25%

Blood bilirubin increased

25%

Amylase increased

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%

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,523 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,319 Total Patients Enrolled

Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

68,638 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

Frequently Asked Questions

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

How many sites will participants be able to access this research?

"The research team has established 32 sites in cities such as Berkeley Heights, Cincinnati and Orange to name a few. If you plan on participating, it would be beneficial to find the clinic nearest your location so that commuting is kept at a minimum."

Answered by AI

Is there a precedent for utilizing Tepotinib in clinical research?

"Presently, five experimental trials are being conducted to study the effects of tepotinib. Unfortunately, none of these studies have progressed into Phase 3 yet. Despite this setback, 358 clinical centres around the world - including in Bialystok and New jersey - are running research on Tepotinib's effectiveness."

Answered by AI

Are there still opportunities to join this experimentation?

"Unfortunately, recruitment for this clinical trial has since ceased and the last update was recorded as of October 6th 2022. If you are seeking alternate trials, there is currently a cohort of 1904 studies recruiting patients with carcinoma non-small-cell lung cancer and 5 studies specifically searching for Tepotinib participants."

Answered by AI

What potential hazards accompany treatment with Tepotinib?

"Although there is limited clinical data for efficacy, tepotinib has been deemed safe enough to receive a score of 2."

Answered by AI

Has there been a similar research project to this one previously?

"There are 5 ongoing clinical trials that include Tepotinib, spanning across 21 countries and 74 cities. Merck KGaA, Darmstadt, Germany initiated the first of these studies back in 2016 with 337 participants; it made it to Phase 2 drug approval before concluding. Since then a further 12 have been conducted."

Answered by AI

Could you provide the aggregate number of participants involved in this experiment?

"This clinical trial is no longer recruiting. The first post was made on September 13th 2016, and the most recent update came on October 6th 2022. If you are seeking other alternatives, there are currently 1904 trials involving carcinoma and non-small cell lung cancer actively enrolling participants; additionally, 5 studies targeting Tepotinib have active recruitment as well."

Answered by AI

Recent research and studies

metJournal

Tepotinib in Non–small-cell Lung Cancer with <i>met</i> Exon 14 Skipping Mutations

Paik, Paul K., Enriqueta Felip, Remi Veillon, Hiroshi Sakai, Alexis B. Cortot, Marina C. Garassino, Julien Mazieres, et al.. 2020. “Tepotinib in Non–small-cell Lung Cancer with met Exon 14 Skipping Mutations”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2004407.

Cancer Chemotherapy and PharmacologyJournal

Population Pharmacokinetic Analysis of Tepotinib, an Oral MET Kinase Inhibitor, Including Data from the VISION Study

Xiong, Wenyuan, Orestis Papasouliotis, E. Niclas Jonsson, Rainer Strotmann, and Pascal Girard. 2022. “Population Pharmacokinetic Analysis of Tepotinib, an Oral MET Kinase Inhibitor, Including Data from the VISION Study”. Cancer Chemotherapy and Pharmacology. Springer Science and Business Media LLC. doi:10.1007/s00280-022-04423-5.

Cancer Chemotherapy and PharmacologyJournal

Exposure–response Analyses for the MET Inhibitor Tepotinib Including Patients in the Pivotal VISION Trial: Support for Dosage Recommendations

Xiong, Wenyuan, Sofia Friberg Hietala, Joakim Nyberg, Orestis Papasouliotis, Andreas Johne, Karin Berghoff, Kosalaram Goteti, et al.. 2022. “Exposure–response Analyses for the MET Inhibitor Tepotinib Including Patients in the Pivotal VISION Trial: Support for Dosage Recommendations”. Cancer Chemotherapy and Pharmacology. Springer Science and Business Media LLC. doi:10.1007/s00280-022-04441-3.

Cancer Chemotherapy and PharmacologyJournal