Tepotinib for Non-Small Cell Lung Cancer

Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Pulmonology & Tuberculosis, Bialystok, Poland
Non-Small Cell Lung CancerTepotinib - Drug
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Advanced Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 Skipping Alterations or MET Amplification

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Baseline up to 20 months

Month 20
Progression free survival as assessed by independent review committee
Progression free survival as assessed by investigator
Month 20
Duration of response as assessed by independent review committee
Duration of response as assessed by investigator
Month 20
Overall survival
Month 20
EuroQol Five Dimension Five Level Scale (EQ5D5L)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis).
Objective disease control as assessed by independent review committee
Objective disease control as assessed by investigator
Objective response as assessed by independent review committee
Objective response assessed as per Investigator
Percentage of subjects with of markedly abnormal clinical laboratory tests, vital signs, Electrocardiogram (ECG) and Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Month 20
Occurrence of Treatment emergent adverse event (TEAEs) and deaths
Day 1
Plasma concentrations of the drug

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Phase 1b: Tepotinib 300 mg
75%Oedema peripheral
50%Abdominal pain
50%Blood alkaline phosphatase increased
50%Alanine aminotransferase increased
25%Disease progression
25%Eyelid oedema
25%Weight decreased
25%Rib fracture
25%Gamma-glutamyltransferase increased
25%Blood creatinine increased
25%Back pain
25%Musculoskeletal chest pain
25%Flank pain
25%Pain in extremity
25%Migraine with aura
25%Post procedural infection
25%Decreased appetite
25%Acute kidney injury
25%Dry mouth
25%Renal impairment
25%Blood bilirubin increased
25%Lumbar vertebral fracture
25%Peripheral venous disease
25%Amylase increased
25%Aspartate aminotransferase increased
25%Lipase increased
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT02115373) in the Phase 1b: Tepotinib 300 mg ARM group. Side effects include: Oedema peripheral with 75%, Constipation with 50%, Abdominal pain with 50%, Blood alkaline phosphatase increased with 50%, Vomiting with 50%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

337 Total Participants · 1 Treatment Group

Primary Treatment: Tepotinib · No Placebo Group · Phase 2

Experimental Group · 1 Intervention: Tepotinib · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 20 months

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
432 Previous Clinical Trials
113,467 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
75 Previous Clinical Trials
30,321 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
281 Previous Clinical Trials
67,733 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.