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

Non-Small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03447769
• Other study ID #: CACZ885T2301
• Secondary ID: 2017-004011-39
• Status: Terminated
• Phase: Phase 3
• Start date: March 16, 2018
• Est. completion date: February 7, 2023

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1382
• Est. completion date: February 7, 2023
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Canakinumab
200 mg of canakinumab administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Canakinumab solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.
• Placebo
Placebo administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Placebo solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Sante Fe
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Klagenfurt
Austria	Novartis Investigative Site	Krems
Austria	Novartis Investigative Site	Vienna
Brazil	Novartis Investigative Site	Barretos	SP
Brazil	Novartis Investigative Site	Londrina	PR
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Teresina	Piaui
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Quebec
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Santiago
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Chang Chun	Jilin
China	Novartis Investigative Site	Changsha
China	Novartis Investigative Site	Chengdu
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Fujian
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Hefei	Anhui
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shanghai	Shanghai
China	Novartis Investigative Site	Shenyang	Liaoning
China	Novartis Investigative Site	Shenyang	Shengyang
China	Novartis Investigative Site	Shenzhen	Guangdong
China	Novartis Investigative Site	Suzhou	Jiangsu
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	XI An	Shanxi
China	Novartis Investigative Site	Zhanjing	Guangong
China	Novartis Investigative Site	Zhengzhou	Henan
China	Novartis Investigative Site	Zunyi	Guizhou
Colombia	Novartis Investigative Site	Bogota
Czechia	Novartis Investigative Site	Ostrava Vitkovice
Czechia	Novartis Investigative Site	Prague 2
France	Novartis Investigative Site	Amiens
France	Novartis Investigative Site	Angers Cedex 9
France	Novartis Investigative Site	Avignon Cedex
France	Novartis Investigative Site	Bayonne
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Bron
France	Novartis Investigative Site	Clermont-Ferrand
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	La Rochelle
France	Novartis Investigative Site	La Seyne sur mer
France	Novartis Investigative Site	Le Mans	Cedex 09
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Marseille cedex 20	Bouches Du Rhone
France	Novartis Investigative Site	Montpellier cedex 5	Herault
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Pessac Cedex
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Saint-Herblain Cédex
France	Novartis Investigative Site	Strasbourg Cedex
France	Novartis Investigative Site	Suresnes
France	Novartis Investigative Site	Toulouse
Georgia	Novartis Investigative Site	Batumi
Georgia	Novartis Investigative Site	Tbilisi
Georgia	Novartis Investigative Site	Tbilisi
Georgia	Novartis Investigative Site	Tbilisi
Georgia	Novartis Investigative Site	Tbilisi
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum	Nordrhein Westfalen
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Gauting	Bayern
Germany	Novartis Investigative Site	Georgsmarienhuette
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Gerlingen
Germany	Novartis Investigative Site	Grosshansdorf
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Heidelberg	Baden-Württemberg
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Velbert	North Rhine-Westphalia
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Athens	Attica
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki
Hong Kong	Novartis Investigative Site	Hong Kong
Hong Kong	Novartis Investigative Site	Kowloon
Hong Kong	Novartis Investigative Site	Tuen Mun
Hungary	Novartis Investigative Site	Torokbalint	Pest
Hungary	Novartis Investigative Site	Veszprem
Iceland	Novartis Investigative Site	Reykjavik
India	Novartis Investigative Site	Delhi
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Holon
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Meldola	FC
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Monza	MB
Italy	Novartis Investigative Site	Orbassano	TO
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Perugia	PG
Italy	Novartis Investigative Site	Ravenna	RA
Italy	Novartis Investigative Site	Roma	RM
Japan	Novartis Investigative Site	Asahikawa-city	Hokkaido
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Hidaka-city	Saitama
Japan	Novartis Investigative Site	Himeji	Hyogo
Japan	Novartis Investigative Site	Hirakata-city	Osaka
Japan	Novartis Investigative Site	Hirosaki	Aomori
Japan	Novartis Investigative Site	Iizuka-city	Fukuoka
Japan	Novartis Investigative Site	Kanazawa-city	Ishikawa
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Minato ku	Tokyo
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Natori	Miyagi
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Sakai	Osaka
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Shiwa-gun	Iwate
Japan	Novartis Investigative Site	Sunto Gun	Shizuoka
Japan	Novartis Investigative Site	Ube-city	Yamaguchi
Japan	Novartis Investigative Site	Wakayama
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Jordan	Novartis Investigative Site	Amman
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Cheongju si	Chungcheongbuk Do
Korea, Republic of	Novartis Investigative Site	Jeollanam-do	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Lebanon	Novartis Investigative Site	Ashrafieh
Lebanon	Novartis Investigative Site	Beirut
Lebanon	Novartis Investigative Site	Saida
Lebanon	Novartis Investigative Site	Tripoli
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuching	Sarawak
Malaysia	Novartis Investigative Site	Pulau Pinang
Norway	Novartis Investigative Site	Bergen
Norway	Novartis Investigative Site	Drammen
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Tromso
Panama	Novartis Investigative Site	Panama City
Peru	Novartis Investigative Site	San Borja	Lima
Peru	Novartis Investigative Site	Surquillo	Lima
Philippines	Novartis Investigative Site	Makati City
Poland	Novartis Investigative Site	Konin
Poland	Novartis Investigative Site	Krakow	Ma3opolska
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Rzeszow
Poland	Novartis Investigative Site	Warszawa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Matosinhos
Portugal	Novartis Investigative Site	Porto
Romania	Novartis Investigative Site	Bucuresti
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Floresti	Cluj
Romania	Novartis Investigative Site	Iasi
Russian Federation	Novartis Investigative Site	Arkhangelsk
Russian Federation	Novartis Investigative Site	Kaliningrad
Russian Federation	Novartis Investigative Site	Moscow Region Istra Village
Russian Federation	Novartis Investigative Site	Obninsk
Russian Federation	Novartis Investigative Site	Omsk
Russian Federation	Novartis Investigative Site	Pushkin Saint Petersburg
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Slovenia	Novartis Investigative Site	Ljubljana
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Hospitalet de LLobregat	Catalunya
Spain	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago De Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Fribourg
Switzerland	Novartis Investigative Site	Geneve 14
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Hualien
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taichung	Taiwan ROC
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chaingmai
Thailand	Novartis Investigative Site	Khon Kaen	THA
Thailand	Novartis Investigative Site	Songkhla	Hat Yai
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara	Yenimahalle
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Pendik Istanbul
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Cambridge	Cambrigdeshire
United Kingdom	Novartis Investigative Site	Cheltenham	Gloucestershire
United Kingdom	Novartis Investigative Site	Guildford	Surrey
United Kingdom	Novartis Investigative Site	Ipswich	Suffolk
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Oxford
United Kingdom	Novartis Investigative Site	Preston
United Kingdom	Novartis Investigative Site	Stoke-on-Trent
United Kingdom	Novartis Investigative Site	Truro	Cornwall
United Kingdom	Novartis Investigative Site	Wirral	Merseyside
United States	Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology	Chattanooga	Tennessee
United States	Rush University Medical Center Regulatory	Chicago	Illinois
United States	Louis Stokes Cleveland Department of Veterans Affairs MC .	Cleveland	Ohio
United States	Texas Oncology MamieMcFaddenWardCtr	Dallas	Texas
United States	Oncology Associates of Oregon, PC	Eugene	Oregon
United States	Virginia Cancer Specialists Fairfax Northern Virginia	Fairfax	Virginia
United States	Highlands Oncology Group .	Fayetteville	Arkansas
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)	Longmont	Colorado
United States	Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	University of California at Los Angeles	Los Angeles	California
United States	Advanced Medical Specialties Drug Ship - 2	Miami	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Florida Cancer Affiliates of Ocala	Ocala	Florida
United States	VA Nebraska-W IA Health Care System .	Omaha	Nebraska
United States	VA Palo Alto Health Care System CRLX030A2301	Palo Alto	California
United States	Florida Cancer Specialists North	Saint Petersburg	Florida
United States	Oncology and Hematology Associates of Southwest Virginia Inc .	Salem	Virginia
United States	Sansum Clinic	Santa Barbara	California
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Cancer Center of Kansas Dept.ofCancerCtr.ofKansas	Wichita	Kansas
Vietnam	Novartis Investigative Site	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Austria,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  Iceland,  India,  Israel,  Italy,  Japan,  Jordan,  Korea, Republic of,  Lebanon,  Malaysia,  Norway,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Slovenia,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS) by Local Investigator	DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.; The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.	Up to approximately 4 years
Secondary	Overall Survival (OS)	Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.	Up to approximately 4.3 years
Secondary	Overall Survival (OS) in PD-L1 Subgroups	Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 <1%, PD-L1 =1% and <49%, and PD-L1 =50%.	Up to approximately 4.3 years
Secondary	Overall Survival (OS) in CD8 Subgroups	Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.	up to approximately 4.3 years
Secondary	Lung Cancer Specific Survival (LCSS)	LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.	Up to approximately 4.3 years
Secondary	Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups	DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.; The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.; DFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 <1%, PD-L1 =1% and <49%, and PD-L1 =50%.	Up to approximately 4 years
Secondary	Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups	DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.; The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.; DFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.	Up to approximately 4 years
Secondary	Canakinumab Serum Concentrations	Serum concentrations of canakinumab were determinded using an ELISA method.	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
Secondary	Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline	Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline	Baseline
Secondary	Canakinumab ADA Incidence	Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)	From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years
Secondary	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	The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.; The time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier.	From baseline up to approximately 4 years
Secondary	Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire	The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.; The time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.	From baseline up to approximately 4 years
Secondary	Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire	The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.; The time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.	From baseline up to approximately 4 years
Secondary	Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire	The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.; The time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.	From baseline up to approximately 4 years
Secondary	Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)	EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems).; The EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)	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.