A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification
The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.
Checked against the public recordLast updated Feb 24, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: INC280 single agent; Drug: erlotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Locally advanced or metastatic NSCLC * EGFR mutation (L858R and /or ex19del) * cMET amplification by FISH (GCN ≥ 6), * Acquired resistance to EGFR TKI (1st or 2nd generation) * ECOG performance status (PS) ≤ 1. Exclusion Criteria: * Prior treatment with 3rd generation TKI * PhaseII : Prior treatment with any of the following agents: * Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor. * Concomitant EGFR TKI and platinum based chemotherapy as first line regimen. * Platinum-based chemotherapy as first line treatment
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Los Angeles Hematology/Oncology Medical GroupLos Angeles, California
- University of California Irvine Medical Center Chao Family SCOrange, California
- Henry Ford Hospital SCDetroit, Michigan
- Dartmouth Hitchcock Medical Center SCLebanon, New Hampshire
- Seattle Cancer Care AllianceSeattle, Washington
- Novartis Investigative SiteBrussels
- Novartis Investigative SiteCharleroi
- Novartis Investigative SiteNice, Alpes Maritimes
- Novartis Investigative SiteBordeaux
- Novartis Investigative SiteCaen
- Novartis Investigative SiteMarseille
- Novartis Investigative SiteStrasbourg
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 24, 2020. Always confirm current availability with the study team.