Clinical trial NCT03447769: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
ACZ885
canakinumab
adjuvant
AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 1382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Detailed description: This was a phase III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult patients with stages AJCC/UICC v.8 II-IIIA and IIIB (T\>5 cm N2) completely resected (R0) NSCLC.

Approximately 1500 patients were planned to be randomized 1:1 to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo s.c. every 3 weeks. Patients were planned to continue their assigned treatment until they completed 18 cycles (cycle= 21 days) or experienced any one of the following: non-small cell lung cancer (NSCLC) disease recurrence as determined by Investigator; unacceptable toxicity that precluded further treatment; treatment discontinuation at the discretion of the Investigator or patient; start of a new antineoplastic therapy; death, or loss to follow-up, whichever occurred first. All patients who discontinued from the study treatment were to be followed up every 12 weeks for survival until the final OS analysis or death, loss to follow-up or withdrawal of consent for survival follow-up.

Eligibility criteria: Key Inclusion Criteria:

* Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for complete resection surgery.
* Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy was mandatory, after which additional therapies could be given based upon local clinical practice and/or guidelines. Typically, chemotherapy was initiated within 60 days of surgery.
* Radiation therapy was allowed if indicated as per local guidelines or practice.
* Had recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy were allowed to enter the study
* Had ECOG performance status (PS) of 0 or 1

Key Exclusion Criteria:

* Had unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
* Had received any neoadjuvant therapy
* Had presence or history of a malignant disease, other than the resected NSCLC, that had been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion included 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.
* Had a history of current diagnosis of cardiac disease
* Had uncontrolled diabetes
* Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
* Subjects had to be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis were not eligible.
* Had suspected or proven immunocompromised state as described in the protocol
* Had live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).

Primary outcomes:
measure: Disease Free Survival (DFS) by Local Investigator
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 4.3 years
measure: Overall Survival (OS) in PD-L1 Subgroups
timeFrame: Up to approximately 4.3 years
measure: Overall Survival (OS) in CD8 Subgroups
timeFrame: up to approximately 4.3 years
measure: Lung Cancer Specific Survival (LCSS)
timeFrame: Up to approximately 4.3 years
measure: Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups
timeFrame: Up to approximately 4 years
measure: Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups
timeFrame: Up to approximately 4 years
measure: Canakinumab Serum Concentrations
timeFrame: Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days
measure: Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline
timeFrame: Baseline
measure: Canakinumab ADA Incidence
timeFrame: From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years
measure: Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
timeFrame: From baseline up to approximately 4 years
measure: Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
timeFrame: From baseline up to approximately 4 years
measure: Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
timeFrame: From baseline up to approximately 4 years
measure: Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
timeFrame: From baseline up to approximately 4 years
measure: Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)
timeFrame: Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group .
state: Arkansas
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System CRLX030A2301
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties Drug Ship - 2
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates of Ocala
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists North
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center Regulatory
state: Illinois
city: Wichita
country: United States
facility: Cancer Center of Kansas Dept.ofCancerCtr.ofKansas
state: Kansas
city: Omaha
country: United States
facility: VA Nebraska-W IA Health Care System .
state: Nebraska
city: Cleveland
country: United States
facility: Louis Stokes Cleveland Department of Veterans Affairs MC .
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC
state: Oregon
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology MamieMcFaddenWardCtr
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists Fairfax Northern Virginia
state: Virginia
city: Salem
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia Inc .
state: Virginia
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
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city: Rosario
country: Argentina
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city: Rosario
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city: Cordoba
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state: PR
city: Barretos
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state: SP
city: Sao Paulo
country: Brazil
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state: SP
city: Sao Paulo
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city: Sofia
country: Bulgaria
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city: Guangzhou
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state: Guangdong
city: Zhanjing
country: China
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state: Guangong
city: Zunyi
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state: Guizhou
city: Zhengzhou
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state: Henan
city: Nanjing
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state: Jiangsu
city: Suzhou
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state: Jiangsu
city: Chang Chun
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state: Jilin
city: Shenyang
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state: Liaoning
city: Jinan
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city: Shanghai
country: China
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state: Shanghai
city: Shanghai
country: China
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state: Shanghai
city: XI An
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state: Shanxi
city: Shenyang
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state: Shengyang
city: Chengdu
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state: Sichuan
city: Hangzhou
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state: Zhejiang
city: Hangzhou
country: China
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state: Zhejiang
city: Beijing
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facility: Novartis Investigative Site
city: Changsha
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city: Prague 2
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city: Marseille cedex 20
country: France
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state: Bouches Du Rhone
city: Le Mans
country: France
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state: Cedex 09
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
state: Herault
city: Amiens
country: France
facility: Novartis Investigative Site
city: Angers Cedex 9
country: France
facility: Novartis Investigative Site
city: Avignon Cedex
country: France
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city: Bayonne
country: France
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city: Brest
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city: Bron
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city: Clermont-Ferrand
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city: La Rochelle
country: France
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city: La Seyne sur mer
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city: Lille
country: France
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city: Paris
country: France
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city: Paris
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city: Pessac Cedex
country: France
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city: Poitiers
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country: France
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city: Strasbourg Cedex
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city: Toulouse
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city: Tbilisi
country: Georgia
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country: Georgia
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city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
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city: Heidelberg
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state: Baden-Württemberg
city: Gauting
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state: Bayern
city: Bochum
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state: North Rhine-Westphalia
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city: Berlin
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facility: Novartis Investigative Site
city: Berlin
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city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
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facility: Novartis Investigative Site
city: Dresden
country: Germany
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city: Erfurt
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city: Essen
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city: Gera
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city: Gerlingen
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city: Grosshansdorf
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facility: Novartis Investigative Site
city: Halle (Saale)
country: Germany
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city: Koeln
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facility: Novartis Investigative Site
city: Leipzig
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city: Minden
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city: Muenchen
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city: Solingen
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city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: Attica
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
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city: Kowloon
country: Hong Kong
facility: Novartis Investigative Site
city: Tuen Mun
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country: Hungary
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state: Pest
city: Veszprem
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city: Reykjavik
country: Iceland
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city: Mumbai
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state: Maharashtra
city: Kolkata
country: India
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state: West Bengal
city: Delhi
country: India
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city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Holon
country: Israel
facility: Novartis Investigative Site
city: Ancona
country: Italy
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state: AN
city: Bari
country: Italy
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state: BA
city: Meldola
country: Italy
facility: Novartis Investigative Site
state: FC
city: Monza
country: Italy
facility: Novartis Investigative Site
state: MB
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Ravenna
country: Italy
facility: Novartis Investigative Site
state: RA
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Hirosaki
country: Japan
facility: Novartis Investigative Site
state: Aomori
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Iizuka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Asahikawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Himeji
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kanazawa-city
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Shiwa-gun
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Natori
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Hirakata-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Hidaka-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Sunto Gun
country: Japan
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state: Shizuoka
city: Bunkyo ku
country: Japan
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state: Tokyo
city: Chuo ku
country: Japan
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state: Tokyo
city: Minato ku
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state: Tokyo
city: Ube-city
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state: Yamaguchi
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
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city: Amman
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facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
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facility: Novartis Investigative Site
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city: Ashrafieh
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country: Panama
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city: San Borja
country: Peru
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state: Lima
city: Surquillo
country: Peru
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state: Lima
city: Makati City
country: Philippines
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city: Krakow
country: Poland
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state: Ma3opolska
city: Konin
country: Poland
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country: Poland
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city: Poznan
country: Poland
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city: Rzeszow
country: Poland
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city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
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city: Matosinhos
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Floresti
country: Romania
facility: Novartis Investigative Site
state: Cluj
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
city: Arkhangelsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kaliningrad
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow Region Istra Village
country: Russian Federation
facility: Novartis Investigative Site
city: Obninsk
country: Russian Federation
facility: Novartis Investigative Site
city: Omsk
country: Russian Federation
facility: Novartis Investigative Site
city: Pushkin Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
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city: St Petersburg
country: Russian Federation
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city: St Petersburg
country: Russian Federation
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city: Yaroslavl
country: Russian Federation
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city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
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state: Andalucia
city: Sevilla
country: Spain
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state: Andalucia
city: Santander
country: Spain
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state: Cantabria
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Hospitalet de LLobregat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz De Tenerife
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Fribourg
country: Switzerland
facility: Novartis Investigative Site
city: Geneve 14
country: Switzerland
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Hualien
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Songkhla
country: Thailand
facility: Novartis Investigative Site
state: Hat Yai
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chaingmai
country: Thailand
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
state: Yenimahalle
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Pendik Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
state: Cambrigdeshire
city: Truro
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Cheltenham
country: United Kingdom
facility: Novartis Investigative Site
state: Gloucestershire
city: Wirral
country: United Kingdom
facility: Novartis Investigative Site
state: Merseyside
city: Ipswich
country: United Kingdom
facility: Novartis Investigative Site
state: Suffolk
city: Guildford
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Preston
country: United Kingdom
facility: Novartis Investigative Site
city: Stoke-on-Trent
country: United Kingdom
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: