A Study of the Safety and Effectiveness of INC280 Alone and in Combination with Erlotinib, When Compared to Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutation and Amplified cMET

Overview

About this study

The purpose of this study is to determine the maximum tolerated dose, the next recommended study dose, and the anti-tumor activity and safety of INC280 alone and in combination with erlotinib, when compared to standard platinum with pemetrexed chemotheapy in adult patients who have EGFR mutated and cMET amplified advanced/metastatic non-small cell lung cancer,and have acquired resistance to prior EGFR tyrosine kinase inhibitors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Locally advanced or metastatic non small cell lung cancer
  • EGFR mutation (L858R and/or ex19del)
  • cMET amplification by FISH (GCN ≥ 6)
  • Acquired resistance to EGFR tyrosine kinase inhibitors (1st or 2nd generation)
  • ECOG performance status (PS) ≤ 1

Exclusion Criteria

  • Prior treatment with 3rd generation tyrosine kinase inhibitors
  • For phase II, 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions