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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:June 11, 2015
End Date:September 30, 2022
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase II, Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC)

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.


Inclusion Criteria:

- Stage IIIB or IV NSCLC (any histology) at the time of study entry

- Histologically or cytologically confirmed diagnosis of NSCLC that is:

1. EGFR wt as per patient standard of care by a validated test

2. AND ALK-negative rearrangement as part of the patient standard of care by a
validated test

3. 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

Other protocol-defined exclusion criteria may apply
We found this trial at
34
sites
Detroit, Michigan 48201
Principal Investigator: Misako M. Nagasaka
Phone: 313-576-9454
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jhanelle B. Gray
Phone: 888-663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Allentown, Pennsylvania 18103
Principal Investigator: Eliot Friedman
Phone: 610-402-0546
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2215 Fuller Rd
Ann Arbor, Michigan 48105
Principal Investigator: Nithya Ramnath
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Atlanta, Georgia 30322
Principal Investigator: Taofeek K K. Owonikoko
Phone: 404-778-4576
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Boston, Massachusetts 02114
Principal Investigator: Rebecca Heist
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Boston, Massachusetts 02131
Principal Investigator: Valia Boosalis
Phone: +1 617 617 632 5607
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Buffalo, New York 14263
Principal Investigator: Hongbin A. Chen
Phone: 716-845-4886
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Caba, Buenos Aires
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Camp Hill, Pennsylvania 17011
Principal Investigator: Yang Liu
Phone: 717-761-8740
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: James Wade
Phone: 217-876-6609
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Detroit, Michigan 48202
Principal Investigator: Igor Rybkin
Phone: 313-916-1784
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Durham, North Carolina 27705
Principal Investigator: Michael Kelley
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Fairfax, Virginia 22031
Principal Investigator: Alexander Spira
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Greenville, South Carolina 29615
Principal Investigator: Britt Bolemon
Phone: 864-242-2762
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Houston, Texas 77203
Principal Investigator: Julio Peguero
Phone: 713-600-0991
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Iowa City, Iowa 52242
Principal Investigator: Muhammad Furqan
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Kansas City, Missouri 64111
Principal Investigator: Janakiraman Subramanian
Phone: 816-932-2677
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Lebanon, New Hampshire 03756
Principal Investigator: Konstantin Dragnev
Phone: 603-650-4428
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Little Rock, Arkansas 72205
Principal Investigator: Konstantinos Arnaoutakis
Phone: +501 526 6990 ext 8026
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Long Beach, California 90813
Principal Investigator: Danny Nguyen
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Los Angeles, California 90017
Principal Investigator: Boris Bagdasarian
Phone: 213-977-1214
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Los Angeles, California 90095
Principal Investigator: Edward B. Garon
Phone: 310-582-4069
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Marietta, Georgia 30060
Principal Investigator: Steve McCune
Phone: 770-281-5100
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1 Veterans Drive
Minneaplois, Michigan 55417
Principal Investigator: Mark Klein
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Nashville, Tennessee 37203
Principal Investigator: Todd M. Bauer
Phone: 615-329-7484
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Omaha, Nebraska 68105
Principal Investigator: Apar Ganti
Phone: 402-995-3330
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Orange, California 92868
Principal Investigator: Sai-Hong Ignatius Ou
Phone: +1 714 456 8104
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Portland, Oregon 97239
Principal Investigator: Khaled Tolba
Phone: 503-418-9736
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Rochester, Minnesota 55905
Principal Investigator: Aaron S. Mansfield
Phone: 507-538-6646
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Salt Lake City, Utah 84103
Principal Investigator: Wallace Akerley
Phone: 801-585-0443
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San Antonio, Texas 78229
Principal Investigator: Anand B. Karnad
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Washington, District of Columbia
Principal Investigator: Deepa S Subramaniam
Phone: 202-687-9861
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950 Campbell Avenue
West Haven, Connecticut 06516
Principal Investigator: Herta Chao
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