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 | 
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).
			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
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									3840 Broadway
Fort Myers, Florida 33901
	
			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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								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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								Dallas, Texas 75251			
	
			
					Principal Investigator: Kristi J. McIntyre
			
						
										Phone: 214-739-4175
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									8196 Walnut Hill Lane
Dallas, Texas 75231
	
			
					Dallas, Texas 75231
Principal Investigator: Srinivasu R Moparty
			
						
										Phone: 214-943-9911
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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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									3322 West End Avenue
Nashville, Tennessee 37203
	
			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
	
			
					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
	
			
					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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								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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