Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 16, 2018
End Date:September 15, 2025
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)

The primary purpose of the study is to compare the efficacy and safety of canakinumab versus
placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the
subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer
(NSCLC).


Inclusion Criteria:

- Written informed consent must be obtained prior to any screening procedures

- Subjects must have recovered from all toxicities related to prior systemic therapy to
grade ≤ 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of
alopecia and grade 2 or less neuropathy are allowed to enter the study

- ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

- Subjects with unresectable or metastatic disease, positive microscopic margins on the
pathology report, and/or gross disease remaining at the time of surgery

- Subjects who received neoadjuvant chemotherapy or neoadjuvant radiotherapy

- Presence or history of a malignant disease, other than the resected NSCLC, that has
been diagnosed and/or required therapy within the past 3 years Exceptions to this
exclusion include the following: completely resected basal cell and squamous cell skin
cancers, completely resected carcinoma in situ of any type and hormonal maintenance
for breast and prostate cancer > 3 years.

- Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C
(positive or indeterminate central laboratory results)

- Subjects must be evaluated for tuberculosis as per local treatment guidelines or
clinical practice. Subjects with active tuberculosis are not eligible.

- Subjects with suspected or proven immunocompromised state as described in the protocol

- Live and attenuated vaccination within 3 months prior to first dose of study drug
(e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
We found this trial at
33
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Dallas, Texas 75251
Principal Investigator: Kristi J. McIntyre
Phone: 214-739-4175
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Fadi Kayali
Phone: 239-274-9930
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Edward B. Garon
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Abilene, Texas 79701
Principal Investigator: Anton Melnyk
Phone: 325-692-0188
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Albany, New York 12208
Principal Investigator: Makenzi Evangelist
Phone: 518-262-6696
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Bakersfield, California 93309
Principal Investigator: David Kanamori
Phone: 661-322-2206
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Bedford, Texas 76022
Principal Investigator: Henrik Illum
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Berazategui, Buenos Aires
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Chattanooga, Tennessee 37404
Principal Investigator: Davey B. Daniel
Phone: 423-698-1844
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Dallas, Texas 75246
Principal Investigator: Scott A. McKenney
Phone: 409-899-7180
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8196 Walnut Hill Lane
Dallas, Texas 75231
Principal Investigator: Srinivasu R Moparty
Phone: 214-943-9911
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Eugene, Oregon 97401
Principal Investigator: Marc Uemura
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Fairfax, Virginia 22031
Principal Investigator: Alexander Spira
Phone: 703-208-3148
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Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 317-436-0800
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Fort Worth, Texas 76104
Principal Investigator: Stephen L. Richey
Phone: 817-263-2670
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Fullerton, California 92835
Principal Investigator: William Lawler
Phone: 714-446-5900
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Greenwood Village, Colorado 80220
Principal Investigator: Robert M. Jotte
Phone: 303-338-4876
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Kansas City, Missouri 64132
Principal Investigator: Joseph Stilwill
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Miami, Florida 33176
Principal Investigator: Paul Kaywin
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: David Robert Spigel
Phone: +1 615 340 1515
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Omaha, Nebraska 68154
Principal Investigator: Ralph Hauke
Phone: 402-691-6972
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Principal Investigator: Craig Reynolds
Phone: 352-732-4938
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Salem, Virginia 24153
Principal Investigator: Jerome Goldschmidt
Phone: 540-982-0237
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San Antonio, Texas 78229
Principal Investigator: Jesse E. Medellin
Phone: 210-424-2610
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Santa Barbara, California 93105
Principal Investigator: Mukul Gupta
Phone: 805-563-5800
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Santa Maria, California 93454
Principal Investigator: Robert Dichmann
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3700 West State Route 89A
Sedona, Arizona 86336
Principal Investigator: Aghimanyu Ghose
Phone: 480-256-1664
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Silver Spring, Maryland 20904
Principal Investigator: Jun Sun
Phone: 301-933-3216
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Tallahassee, Florida 32308
Principal Investigator: Jeffrey Bubis
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Tyler, Texas 75702
Principal Investigator: Donald A. Richards
Phone: 903-579-9800
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Webster, Texas 77598
Principal Investigator: Alan Rodney
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West Palm Beach, Florida 33401
Principal Investigator: Todd Gersten
Phone: 561-366-4149
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Wichita, Kansas 67214
Principal Investigator: Shaker R. Dakhil
Phone: 316-613-4316
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