Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (Geometry Mono-1)

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)(Geometry Mono-1)

ClinicalTrials.gov Identifier: NCT02414139

Novartis Reference Number: CINC280A2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study 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.

Condition 
Carcinoma, Non-Small-Cell Lung
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
368 participants
Start date 
Jun 11, 2015
Completion date 
Mar 30, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
INC280 (capmatinib)

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

Other protocol-defined exclusion criteria may apply

Study Locations

United States
University of Arkansas for Medical Science SC
Recruiting
Little Rock, 72205
Arkansas
United States
Pacific Shores Medical Group SC
Recruiting
Long Beach, 90813
California
United States
Los Angeles Hematology/Oncology Medical Group
Recruiting
Los Angeles, 90017
California
United States
University of California at Los Angeles Dept of Onc
Recruiting
Los Angeles, 90095
California
United States
University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center
Recruiting
Orange, 92868
California
United States
VA Comprehensive Cancer Center
Recruiting
West Haven, 06516
Connecticut
United States
Georgetown University Lombardi Cancer Center
Recruiting
Washington, 20007 2197
District of Columbia
United States
H Lee Moffitt Cancer Center and Research Institute
Recruiting
Tampa, 33612
Florida
United States
Emory University School of Medicine/Winship Cancer Institute SC-2
Recruiting
Atlanta, 30322
Georgia
United States
Northwest Georgia Oncology Centers P.C
Recruiting
Marietta, 30060
Georgia
United States
Decatur Memorial Hospital
Recruiting
Decatur, 62526
Illinois
United States
University of Iowa Hospitals & Clinics SC-3
Recruiting
Iowa City, 52242
Iowa
United States
Massachusetts General Hospital MGH Cancer Center
Recruiting
Boston, 02114
Massachusetts
United States
Boston VA Healthcare Boston VA
Recruiting
Boston, 02131
Massachusetts
United States
VA Ann Arbor Health System VA Ann Arbor Health System
Recruiting
Ann Arbor, 48105
Michigan
United States
Karmanos Cancer Institute
Recruiting
Detroit, 48201
Michigan
United States
Henry Ford Hospital SC
Recruiting
Detroit, 48202-2689
Michigan
United States
Minneapolis VA Medical Center
Recruiting
Minneaplois, 55417
Michigan
United States
Mayo Clinic
Recruiting
Rochester, 55905
Minnesota
United States
St. Luke's Cancer Institute SC-2
Recruiting
Kansas City, 64111
Missouri
United States
VA Nebraska-Western Iowa Health Care System
Recruiting
Omaha, 68105
Nebraska
United States
Dartmouth Hitchcock Medical Center SC
Recruiting
Lebanon, 03756
New Hampshire
United States
Roswell Park Cancer Institute Rosewell
Recruiting
Buffalo, 14263
New York
United States
Durham VA Medical Center Durham VA Med Ctr -Station 558
Recruiting
Durham, 27705
North Carolina
United States
Oregon Health and Science University SC
Recruiting
Portland, 97239
Oregon
United States
Lehigh Valley Health Network SC
Recruiting
Allentown, 18103
Pennsylvania
United States
Andrew and Patel Associates
Recruiting
Camp Hill, 17011
Pennsylvania
United States
GHS Cancer Intitute
Recruiting
Greenville, 29615
South Carolina
United States
Sarah Cannon Research Institute Sarah Cannon Cancer Center
Recruiting
Nashville, 37203
Tennessee
United States
Oncology Consultants
Active, not recruiting
Houston, 77030
Texas
United States
Cancer Therapy and Research Center UT Health Science Center SC-5
Recruiting
San Antonio, 78229
Texas
United States
University of Utah / Huntsman Cancer Institute Oncology
Recruiting
Salt Lake City, 84103
Utah
United States
Virginia Cancer Specialists Virginia Cancer Specialists
Recruiting
Fairfax, 22031
Virginia
United States
Argentina
Novartis Investigative Site
Completed
Caba, C1426ANZ
Buenos Aires
Argentina
Novartis Investigative Site
Completed
Buenos Aires, C1431FWO
Caba
Argentina
Novartis Investigative Site
Withdrawn
Buenos Aires, C1093AAS
-
Argentina
Novartis Investigative Site
Active, not recruiting
La Rioja, 5300
-
Argentina
Austria
Novartis Investigative Site
Completed
Wien, 1210
-
Austria
Belgium
Novartis Investigative Site
Active, not recruiting
Leuven, 3000
-
Belgium
Brazil
Novartis Investigative Site
Withdrawn
Ljui, 98700
Rio Grande Do Sul
Brazil
Novartis Investigative Site
Withdrawn
Rio De Janiero, 20231-050
RJ
Brazil
Novartis Investigative Site
Withdrawn
Barretos, 14784 400
SP
Brazil
Novartis Investigative Site
Withdrawn
Sao Jose do Rio Preto, 15090 000
SP
Brazil
Novartis Investigative Site
Withdrawn
Sao Paulo, 01246 000
SP
Brazil
Canada
Novartis Investigative Site
Withdrawn
Halifax, B3H 1V7
Nova Scotia
Canada
Novartis Investigative Site
Withdrawn
Ottawa, K1H 8L6
Ontario
Canada
France
Novartis Investigative Site
Withdrawn
Nice Cedex 2, 06189
Alpes Maritimes
France
Novartis Investigative Site
Completed
Marseille cedex 20, 13915
Bouches Du Rhone
France
Novartis Investigative Site
Completed
Dijon Cedex, 21034
Cote D Or
France
Novartis Investigative Site
Completed
Clermont-Ferrand, 63011
-
France
Novartis Investigative Site
Completed
La Tronche, 38700
-
France
Novartis Investigative Site
Completed
LILLE Cédex, 59037
-
France
Novartis Investigative Site
Completed
Marseille, 13273
-
France
Novartis Investigative Site
Completed
Paris, 75970
-
France
Novartis Investigative Site
Active, not recruiting
Pierre Benite, 69495
-
France
Novartis Investigative Site
Completed
Rennes, 35043
-
France
Novartis Investigative Site
Completed
Strasbourg Cedex, 67091
-
France
Germany
Novartis Investigative Site
Active, not recruiting
Heidelberg, 69126
Baden-Württemberg
Germany
Novartis Investigative Site
Withdrawn
Gauting, 82131
Bayern
Germany
Novartis Investigative Site
Active, not recruiting
Koeln, 50937
Nordrhein-Westfalen
Germany
Novartis Investigative Site
Active, not recruiting
Berlin, 13125
-
Germany
Novartis Investigative Site
Active, not recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Withdrawn
Freiburg, 79106
-
Germany
Novartis Investigative Site
Active, not recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Completed
Halle (Saale), 06120
-
Germany
Novartis Investigative Site
Active, not recruiting
Hamburg, 20251
-
Germany
Novartis Investigative Site
Completed
Hannover, 30625
-
Germany
Novartis Investigative Site
Completed
Homburg, 66421
-
Germany
Novartis Investigative Site
Active, not recruiting
Muenchen, 81925
-
Germany
Novartis Investigative Site
Completed
Nuernberg, 90419
-
Germany
Novartis Investigative Site
Completed
Ravensburg, 88214
-
Germany
Novartis Investigative Site
Active, not recruiting
Tübingen, 72076
-
Germany
Novartis Investigative Site
Active, not recruiting
Ulm, 89081
-
Germany
Israel
Novartis Investigative Site
Withdrawn
Haifa, 3525408
-
Israel
Novartis Investigative Site
Withdrawn
Kfar Saba, 4428164
-
Israel
Novartis Investigative Site
Completed
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Completed
Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
Withdrawn
Avellino, 83100
AV
Italy
Novartis Investigative Site
Completed
Bologna, 40138
BO
Italy
Novartis Investigative Site
Completed
Brescia, 25123
BS
Italy
Novartis Investigative Site
Completed
Catania, 95124
CT
Italy
Novartis Investigative Site
Completed
Catanzaro, 88100
CZ
Italy
Novartis Investigative Site
Completed
Meldola, 47014
FC
Italy
Novartis Investigative Site
Active, not recruiting
Firenze, 50134
FI
Italy
Novartis Investigative Site
Withdrawn
Lecce, 73100
LE
Italy
Novartis Investigative Site
Completed
Monza, 20900
MB
Italy
Novartis Investigative Site
Withdrawn
Macerata, 62100
MC
Italy
Novartis Investigative Site
Withdrawn
Taormina, 98039
ME
Italy
Novartis Investigative Site
Withdrawn
Milano, 20132
MI
Italy
Novartis Investigative Site
Active, not recruiting
Milano, 20141
MI
Italy
Novartis Investigative Site
Completed
Milano, 20162
MI
Italy
Novartis Investigative Site
Completed
Modena, 41124
MO
Italy
Novartis Investigative Site
Completed
Roma, 00155
RM
Italy
Novartis Investigative Site
Completed
Verona, 37126
VR
Italy
Novartis Investigative Site
Completed
Napoli, 80131
-
Italy
Japan
Aichi Cancer Center Hospital
Recruiting
Nagoya City, 464-8681
Aichi
Japan
Nagoya University Hospital
Recruiting
Nagoya, 466-8560
Aichi
Japan
National Cancer Center Hospital East
Recruiting
Kashiwa-City, 277-8577
Chiba
Japan
National Kyushu Cancer Center
Recruiting
Minami-Ku, 811-1395
Fukuoka
Japan
Hyogo Cancer Center
Recruiting
Akashi-city, 673-8558
Hyogo
Japan
Sendai Kousei Hospital
Recruiting
Sendai-city, 980-0873
Miyagi
Japan
Okayama University Hospital
Recruiting
Okayama-city, 700-8558
Okayama
Japan
Kinki University Hospital
Recruiting
OsakaSayama-city, 589-8511
Osaka
Japan
National Cancer Center Hospital
Recruiting
Chuo-ku, 104-0045
Tokyo
Japan
Novartis Investigative Site
Active, not recruiting
Koto ku, 135 8550
Tokyo
Japan
National Hospital Organization, Yamaguchi-Ube Medical Center
Recruiting
Ube-city, 755-0241
Yamaguchi
Japan
Korea, Republic of
Novartis Investigative Site
Completed
Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Completed
Gyeonggi do, 10408
Korea
Korea, Republic of
Novartis Investigative Site
Withdrawn
Seoul, 05505
Korea
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Withdrawn
Seoul, 06351
-
Korea, Republic of
Lebanon
Novartis Investigative Site
Active, not recruiting
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
Withdrawn
Beirut, 1107 2020
-
Lebanon
Novartis Investigative Site
Withdrawn
Saida, 652
-
Lebanon
Mexico
Novartis Investigative Site
Withdrawn
Huixquilucan, 3810
DF
Mexico
Novartis Investigative Site
Completed
Mexico, 14080
Distrito Federal
Mexico
Netherlands
NKI-AVL, Department of Thoracic-Oncology
Recruiting
Amsterdam, 1066 CX
-
Netherlands
Novartis Investigative Site
Active, not recruiting
Groningen, 9713 GZ
-
Netherlands
Novartis Investigative Site
Active, not recruiting
Maastricht, 6229 HX
-
Netherlands
Novartis Investigative Site
Active, not recruiting
Rotterdam, 3015 GD
-
Netherlands
Norway
Novartis Investigative Site
Completed
Oslo, NO-0424
-
Norway
Poland
Novartis Investigative Site
Withdrawn
Otwock, 05-400
Mazowieckie
Poland
Novartis Investigative Site
Withdrawn
Gdansk, 80 952
-
Poland
Novartis Investigative Site
Withdrawn
Poznan, 60 569
-
Poland
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 121467
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Saint Petersburg, 192148
-
Russian Federation
Novartis Investigative Site
Withdrawn
St Petersburg, 194291
-
Russian Federation
Novartis Investigative Site
Withdrawn
St.-Petersburg, 198255
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Tambov, 392000
-
Russian Federation
Singapore
Novartis Investigative Site
Completed
Singapore, 119228
-
Singapore
Novartis Investigative Site
Completed
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
Completed
Sevilla, 41017
Andalucia
Spain
Novartis Investigative Site
Recruiting
Oviedo, 33006
Asturias
Spain
Novartis Investigative Site
Completed
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Completed
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Withdrawn
Las Palmas De Gran Canarias, 35016
Las Palmas De Gran Canaria
Spain
Novartis Investigative Site
Withdrawn
Madrid, 28009
-
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28034
-
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28041
-
Spain
Novartis Investigative Site
Withdrawn
Madrid, 28046
-
Spain
Novartis Investigative Site
Withdrawn
Zaragoza, 50009
-
Spain
Sweden
Novartis Investigative Site
Active, not recruiting
Stockholm, SE-171 76
-
Sweden
Novartis Investigative Site
Active, not recruiting
Uppsala, SE-751 85
-
Sweden
Switzerland
Novartis Investigative Site
Withdrawn
Basel, 4031
-
Switzerland
Taiwan
Novartis Investigative Site
Withdrawn
Putzu City, 61363
Chiayi Hsien
Taiwan
Novartis Investigative Site
Active, not recruiting
Kaohsiung, 82445
-
Taiwan
Novartis Investigative Site
Withdrawn
Taichung, 40447
-
Taiwan
Novartis Investigative Site
Completed
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Completed
Taoyuan, 33305
-
Taiwan
Turkey
Novartis Investigative Site
Withdrawn
Ankara, 06100
-
Turkey
Novartis Investigative Site
Withdrawn
Fatih / Istanbul, 34093
-
Turkey
United Kingdom
Novartis Investigative Site
Completed
Birmingham, B9 5SS
-
United Kingdom
Novartis Investigative Site
Withdrawn
London, SE1 9RT
-
United Kingdom
Novartis Investigative Site
Withdrawn
London, W1G 6AD
-
United Kingdom
Novartis Investigative Site
Active, not recruiting
London, W6 8RF
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111

Have a question?

Call 1-999-669-6682 or email [email protected]