Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02864992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
Sponsor:
EMD Serono Research & Development Institute, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: