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TerminatedPhase 1NCT02468661
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINC280 single agent and erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 24, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?32 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
EGFR→
Treatment approach
Targeted therapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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