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NCT02414139 · ClinicalTrials.gov registry record · Phase 2
Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)
A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 373
- Enrollment target
- 20
- Study locations
NCT02414139: Completed Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Novartis Pharmaceuticals.
NCT02414139 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 373 participants, above the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02414139, a Phase 2 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 373 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advanced/metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) who had wild-type epidermal growth factor receptor (EGFR wt) (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK)-negative rearrangement, and mesenchymal epithelial transition (MET) mutations leading to exon 14 deletion (referred to as MET mutation hereafter) and/or MET amplification.
Primary Outcome
Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Conditions Studied
Interventions
- DRUG Capmatinib
Study Locations (20)
California
- Pacific Shores Medical Group SC - Long Beach
- University Of California Los Angeles Dept of Onc - Los Angeles
- University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center - Orange
Other
- Novartis Investigative Site - La Rioja
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Leuven
Pennsylvania
- Lehigh Valley Health Network SC - Allentown
- Andrew and Patel Associates - Camp Hill
Florida
- H Lee Moffitt Cancer Center and Research Institute . - Tampa
Iowa
- University of Iowa Hospitals and Clinics SC-3 - Iowa City
Massachusetts
- Massachusetts General Hospital MGH Cancer Center - Boston
Michigan
- VA Ann Arbor Health System VA Ann Arbor Health System - Ann Arbor
Minnesota
- Mayo Clinic Rochester . - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2015-06-11 |
| Est. Completion | 2023-05-16 |
| Phase | Phase 2 |
What the finished NCT02414139 record still lists
NCT02414139 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, above the 321-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 1 intervention - of which Capmatinib is the first listed.
NCT02414139 names 20 study sites across 15 states, led by California, Other, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02414139 about?
NCT02414139 is a clinical study titled "Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)". Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advanced/metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) who had wild-type epidermal growth factor receptor (EGFR wt) (for exon 19 deletions and exon 21 L858R substitution mutations...
What is the current status of trial NCT02414139?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 373 participants. The study started on 2015-06-11. Estimated completion is 2023-05-16.
What conditions does trial NCT02414139 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT02414139?
The interventions under investigation include: Capmatinib (DRUG).
Who is sponsoring clinical trial NCT02414139?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02414139 being conducted?
This trial has 20 study locations across California, Florida, Iowa, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02414139's enrollment target sits among peer trials
373 35th of 130 higher than 96 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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