Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer

Status: Active

Description

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

Eligibility Criteria

Inclusion Criteria

  • Stage IIIB or IV NSCLC (any histology) at the time of study entry
  • Histologically or cytologically confirmed diagnosis of NSCLC that is:
  • EGFR wt as per patient standard of care by a validated test
  • AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  • AND (by central assessment) either:
  • Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
  • Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
  • Cohort 3: Pre-treated patients with cMET GCN < 4, or
  • Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or
  • Cohort 5: Treatment-naïve patients with cMET dysregulation, or
  • Cohort 6: Pre-treated patients with either cMET GCN ≥ 10 without cMET mutations or cMET mutations regardless of cMET GCN, or
  • Cohort 7: Treatment-naïve patients with cMET mutations regardless of cMET GCN
  • To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  • To be eligible for Cohort 6, patients must have failed one prior line of systemic therapy for advanced/metastatic disease
  • To be eligible for Cohort 5 and Cohort 7, patients must not have received any systemic therapy for advanced/metastatic disease
  • At least one measurable lesion as defined by RECIST 1.1
  • Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
  • Patients must have adequate organ function
  • ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply

Exclusion Criteria

  • Prior treatment with crizotinib, or any other cMET or HGF inhibitor
  • Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
  • Patients with characterized ALK-positive rearrangement
  • Clinically significant, uncontrolled heart diseases.
  • Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
  • Strong inducers of CYP3A4
  • Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  • Patients receiving treatment with any enzyme-inducing anticonvulsant
  • Applicable to Cohorts 1-4 and Cohort 6 only: Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  • Pregnant or nursing women
  • Women of child-bearing potential, unless they are using highly effective methods of contraception
  • Sexually active males unless they use a condom during intercourse
  • Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Edward Brian Garon
Phone: 888-798-0719
Email: egaron@mednet.ucla.edu
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Maria Yuriana Sharma
Email: ucstudy@uci.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Jhanelle E. Gray
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Muhammad Furqan
Email: muhammad-furqan@uiowa.edu

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Susan Symes
Email: ssymes@mgh.harvard.edu

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Julie Marie Gecox
Phone: 507-538-6646
Email: Gecox.Julie@mayo.edu

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Courtney Davis
Phone: 603-650-4428
Email: Courtney.M.Davis@Hitchcock.org

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: In review
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Hongbin Chen
Phone: 877-275-7724
Email: hongbin.chen@roswellpark.org

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Nicole Hillman
Phone: 801-585-0443
Email: nicole.Hillman@hci.utah.edu

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CINC280A2201
Secondary IDs NCI-2015-01536, 2014-003850-15
Clinicaltrials.gov ID NCT02414139