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

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02468661

Run by

Novartis Pharmaceuticals

People needed

23

Starts

2015-09-23

Expected to finish

2018-12-05

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Los Angeles Hematology/Oncology Medical Group — Los Angeles, California, United States
• University of California Irvine Medical Center Chao Family SC — Orange, California, United States
• Henry Ford Hospital SC — Detroit, Michigan, United States
• Dartmouth Hitchcock Medical Center SC — Lebanon, New Hampshire, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Charleroi, Belgium
• Novartis Investigative Site — Nice, Alpes Maritimes, France
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Caen, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Strasbourg, France
• Novartis Investigative Site — Tübingen, Baden-Wurttemberg, Germany
• Novartis Investigative Site — Regensburg, Bavaria, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bergamo, BG, Italy
• Novartis Investigative Site — Brescia, BS, Italy
• Novartis Investigative Site — Meldola, FC, Italy
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Parma, PR, Italy
• Novartis Investigative Site — Verona, VR, Italy
• Novartis Investigative Site — Fukuoka, Fukuoka, Japan
• Novartis Investigative Site — Akashi, Hyōgo, Japan
• Novartis Investigative Site — Sendai, Miyagi, Japan
• Novartis Investigative Site — Okayama, Okayama-ken, Japan

Full record on ClinicalTrials.gov

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