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.
- Advanced Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 Skipping Alterations or MET Amplification
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 15 Secondary · Reporting Duration: Baseline up to 20 months
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
1 Treatment Group
Tepotinib
1 of 1
Experimental Treatment
337 Total Participants · 1 Treatment Group
Primary Treatment: Tepotinib · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- 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.
- 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.
- 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.
- 2016. "Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02864992.
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
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
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
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
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
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