Trials / Active Not Recruiting
Active Not RecruitingNCT02864992
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 337 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study included 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment number and completion data is changed by new cohorts.
Conditions
- Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification
- Lung Adenocarcinoma Stage IIIB/IV
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tepotinib | 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. |
Timeline
- Start date
- 2016-09-13
- Primary completion
- 2022-05-16
- Completion
- 2026-04-30
- First posted
- 2016-08-12
- Last updated
- 2026-04-13
- Results posted
- 2023-06-09
Locations
176 sites across 15 countries: United States, Austria, Belgium, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan
Source: ClinicalTrials.gov record NCT02864992. Inclusion in this directory is not an endorsement.