Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  • Cohort 6: Pre-treated patients with either cMET GCN ≥ 10 without cMET mutations or 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, 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

Other protocol-defined exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
cMET GCN ≥ 6
Pre-treated patients with cMET GCN ≥ 6 treated with INC280 at 400mg BID as second or third line
  • Drug: INC280 (capmatinib)
Experimental
cMET GCN ≥ 4 and < 6
Pre-treated patients with cMET GCN ≥ 4 and < 6 treated with INC280 at 400 mg BID as second or third line
  • Drug: INC280 (capmatinib)
Experimental
cMET GCN < 4
Pre-treated patients with cMET GCN < 4 treated with INC280 at 400mg BID as second or third line
  • Drug: INC280 (capmatinib)
Experimental
cMET mutations
Pre-treated patients with cMET mutations regardless of cMET GCN treated with INC280 at 400mg BID as second or third line
  • Drug: INC280 (capmatinib)
Experimental
cMET dysregulation - treatment-naïve
Treatment-naïve patients with cMET dysregulation treated with INC280 at 400mg BID
  • Drug: INC280 (capmatinib)
Experimental
cMET dysregulation - second line
Pre-treated patients with cMET deregulation treated with INC280 at 400 mg BID as second line
  • Drug: INC280 (capmatinib)

Recruiting Locations

University of Arkansas for Medical Science SC
Little Rock, Arkansas 72205
Contact:
Kathryn Allen
+501 526 6990 ext 8026
KGAllen@uams.edu

Pacific Shores Medical Group SC
Long Beach, California 90813
Contact:
Victoria Lansang
victorial@pacshoresoncology.com

Los Angeles Hematology/Oncology Medical Group
Los Angeles, California 90017
Contact:
Ruma Barva
213-977-1214
rbarva@scoranet.org

University of California at Los Angeles Dept of Onc
Los Angeles, California 90095
Contact:
Sandra Hernandez
310-582-4069
Shernandez@mednet.ucla.edu

University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center
Orange, California 92868
Contact:
Thanh Phan
+1 714 456 8104
tphan@uci.edu

VA Comprehensive Cancer Center
West Haven, Connecticut 06516
Contact:
Sara Turek
Sara.turek@va.gov

Georgetown University Lombardi Cancer Center
Washington, District of Columbia 20007 2197
Contact:
202-687-9861

H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
Contact:
Thanh L. Phan
888-663-3488
tphan@uci.edu

Emory University School of Medicine/Winship Cancer Institute SC-2
Atlanta, Georgia 30322
Contact:
Ellie Butler
404-778-4576
Ellie.Butler@emory.edu

Northwest Georgia Oncology Centers, P.C.,
Marietta, Georgia 30060
Contact:
Feseha Makonnen
770-281-5100
fmakonnen@gnoc.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Cindy Albright
217-876-6609
calbright@dmhhs.org

University of Iowa Hospitals & Clinics SC-3
Iowa City, Iowa 52242

Massachusetts General Hospital MGH Cancer Center
Boston, Massachusetts 02114
Contact:
Susan Symes
ssymes@mgh.harvard.edu

Boston VA Healthcare Boston VA
Boston, Massachusetts 02131
Contact:
Corri Dedomenico
+1 617 617 632 5607
Corri.Dedomenico@va.gov

VA Ann Arbor Health System VA Ann Arbor Health System
Ann Arbor, Michigan 48105
Contact:
Sara Turek
Sara.turek@va.gov

Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Deborah Hackstock
313-576-9454
hackstod@karmanos.org

Henry Ford Hospital SC
Detroit, Michigan 48202-2689
Contact:
Jennifer Carabio
313-916-1784
jcarbi@hfhs.org

Minneapolis VA Medical Center
Minneaplois, Michigan 55417
Contact:
Sara Turek
Sara.turek@va.gov

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Ann Marie Mayer
507-538-6646
mayer.annmarie@mayo.edu

St. Luke's Cancer Institute SC-2
Kansas City, Missouri 64111
Contact:
Jessica Yingling
816-932-2677
jyingling@saint-lukes.org

VA Nebraska-Western Iowa Health Care System
Omaha, Nebraska 68105
Contact:
Holly DeSpiegelaere
402-995-3330
Holly.despiegelaere@va.fov

Dartmouth Hitchcock Medical Center SC
Lebanon, New Hampshire 03756
Contact:
Crystallee Newton
603-650-4428
Crystallee.J.Newton@Hitchcock.org

Roswell Park Cancer Institute Rosewell
Buffalo, New York 14263
Contact:
Kelly Dunn
716-845-4886
kelly.dunn@roswellpark.org

Durham VA Medical Center Durham VA Med Ctr -Station 558
Durham, North Carolina 27705
Contact:
Sara Turek
Sara.turek@va.gov

Oregon Health and Science University SC
Portland, Oregon 97239
Contact:
Investigational Pharmacy
503-418-9736
invdrugs@ohsu.edu

Lehigh Valley Health Network SC
Allentown, Pennsylvania 18103
Contact:
Trina M Grace
610-402-0546
trina_b.grace@lvh.com

Andrew & Patel Associates,
Camp Hill, Pennsylvania 17011
Contact:
Renee Kessler
717-761-8740
rkessler@andrewspatel.com

GHS Cancer Intitute
Greenville, South Carolina 29615
Contact:
Melanie Mayes
864-242-2762
Mmayes2@ghs.org

Sarah Cannon Research Institute Sarah Cannon Cancer Center
Nashville, Tennessee 37203
Contact:
Julie W. Trundle
615-329-7484
Julie.trundle@scresearch.net

Oncology Consultants
Houston, Texas 77030
Contact:
Laura Guerra
713-600-0991
lguerra@oncologyconsultants.com

Cancer Therapy & Research Center UT Health Science Center SC-5
San Antonio, Texas 78229
Contact:
Tyson DeSutter
desutter@uthscsa.edu

University of Utah / Huntsman Cancer Institute Oncology
Salt Lake City, Utah 84103
Contact:
Natalie Graves
801-585-0443
Natalie.graves@hci.utah.edu

Virginia Cancer Specialists Virginia Cancer Specialists
Fairfax, Virginia 22031
Contact:
Monica Cochrane
monica.cochrane@usoncology.com

More Details

NCT ID
NCT02414139
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.