CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 373 enrolled
Drug / intervention
Capmatinibdrug
Likely dose
Capmatinib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02414139
NCT02414139Phase 2Completed
CompareCT.gov

A Phase II, Multicenter Study of Oral MET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

Novartis Pharmaceuticals·interventional·Posted Apr 10, 2015·Updated Mar 20, 2024

In Brief

A Phase 2 clinical trial evaluating Capmatinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 373 participants across 95 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Austria, Belgium, France, Germany, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Norway, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 10, 2015
Enrollment StartJun 11, 2015
Primary CompletionApr 12, 2023
Study CompletionMay 16, 2023
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 11.2 years ago

Interventions

Capmatinibdrug

Capmatinib was administered orally, at a dose of 400 mg on a continuous twice daily dosing schedule. Capmatinib was administered to participants in Cohorts 1a, 1b, 2, 3, 4, 5a and 5b in a fasted state. For Cohorts 6.1. 6.2 and 7, capmatinib was administered either with or without food.