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

Use our guide to learn which trials are right for you!

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
sites
Bedford, Texas 76022
Principal Investigator: Henrik Illum
?
mi
from
Bedford, TX
Click here to add this to my saved trials
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Fadi Kayali
Phone: 239-274-9930
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Abilene, Texas 79701
Principal Investigator: Anton Melnyk
Phone: 325-692-0188
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Albany, New York 12208
Principal Investigator: Makenzi Evangelist
Phone: 518-262-6696
?
mi
from
Albany, NY
Click here to add this to my saved trials
Bakersfield, California 93309
Principal Investigator: David Kanamori
Phone: 661-322-2206
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Berazategui, Buenos Aires
?
mi
from
Berazategui,
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
Principal Investigator: Davey B. Daniel
Phone: 423-698-1844
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Dallas, Texas 75246
Principal Investigator: Scott A. McKenney
Phone: 409-899-7180
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75251
Principal Investigator: Kristi J. McIntyre
Phone: 214-739-4175
?
mi
from
Dallas, TX
Click here to add this to my saved trials
8196 Walnut Hill Lane
Dallas, Texas 75231
Principal Investigator: Srinivasu R Moparty
Phone: 214-943-9911
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Eugene, Oregon 97401
Principal Investigator: Marc Uemura
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Fairfax, Virginia 22031
Principal Investigator: Alexander Spira
Phone: 703-208-3148
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 317-436-0800
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Stephen L. Richey
Phone: 817-263-2670
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fullerton, California 92835
Principal Investigator: William Lawler
Phone: 714-446-5900
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Greenwood Village, Colorado 80220
Principal Investigator: Robert M. Jotte
Phone: 303-338-4876
?
mi
from
Greenwood Village, CO
Click here to add this to my saved trials
Kansas City, Missouri 64132
Principal Investigator: Joseph Stilwill
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Miami, Florida 33176
Principal Investigator: Paul Kaywin
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Omaha, Nebraska 68154
Principal Investigator: Ralph Hauke
Phone: 402-691-6972
?
mi
from
Omaha, NE
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33705
Principal Investigator: Craig Reynolds
Phone: 352-732-4938
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salem, Virginia 24153
Principal Investigator: Jerome Goldschmidt
Phone: 540-982-0237
?
mi
from
Salem, VA
Click here to add this to my saved trials
San Antonio, Texas 78229
Principal Investigator: Jesse E. Medellin
Phone: 210-424-2610
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Santa Barbara, California 93105
Principal Investigator: Mukul Gupta
Phone: 805-563-5800
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Santa Maria, California 93454
Principal Investigator: Robert Dichmann
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
3700 West State Route 89A
Sedona, Arizona 86336
Principal Investigator: Aghimanyu Ghose
Phone: 480-256-1664
?
mi
from
Sedona, AZ
Click here to add this to my saved trials
Silver Spring, Maryland 20904
Principal Investigator: Jun Sun
Phone: 301-933-3216
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
Tallahassee, Florida 32308
Principal Investigator: Jeffrey Bubis
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tyler, Texas 75702
Principal Investigator: Donald A. Richards
Phone: 903-579-9800
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Webster, Texas 77598
Principal Investigator: Alan Rodney
?
mi
from
Webster, TX
Click here to add this to my saved trials
West Palm Beach, Florida 33401
Principal Investigator: Todd Gersten
Phone: 561-366-4149
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Wichita, Kansas 67214
Principal Investigator: Shaker R. Dakhil
Phone: 316-613-4316
?
mi
from
Wichita, KS
Click here to add this to my saved trials