CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 337 enrolled
Drug / intervention
Tepotinibdrug
Likely dose
Tepotinib 500 mg orally once dailyAI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types including squamous and sarcomatoid)
  • ✓Treatment naïve or pretreated with no more than 2 prior lines of therapy
  • ✓MET alterations: METex14 skipping alterations in plasma and/or tissue as determined by central laboratory or assay with appropriate regulatory status
  • ✓Measurable disease confirmed by independent review committee per RECIST v1.1
Key exclusion· 10
  • ✕Characterized EGFR activating mutations that predict sensitivity to anti-EGFR therapy
  • ✕Characterized ALK rearrangements that predict sensitivity to anti-ALK therapy
  • ✕Symptomatic brain metastases with neurological instability
  • ✕Prior treatment with agents targeting HGF/c-Met pathway

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02864992
NCT02864992Phase 2Active
CompareCT.gov

A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

EMD Serono Research & Development Institute, Inc.·interventional·Posted Aug 12, 2016·Updated Apr 13, 2026

In Brief

A Phase 2 clinical trial evaluating Tepotinib for Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification and Lung Adenocarcinoma Stage IIIB/IV. Active but no longer recruiting, targeting 337 participants across 176 sites in 15 countries.

Detailed Summary

This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IV
CountriesAustria, Belgium, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan, United States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 2ActiveOverdue
2017201820192020202120222023202420252026
First PostedAug 12, 2016
Enrollment StartSep 13, 2016
Primary CompletionMay 16, 2022
Study CompletionApr 30, 2026
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 9.9 years ago

Interventions

Tepotinibdrug

Subjects will receive 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.