Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (CANOPY-1)

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: pembrolizumab; Drug: carboplatin; Drug: canakinumab; Drug: pemetrexed; Drug: cisplatin; Drug: paclitaxel; Drug: nab-paclitaxel; Drug: canakinumab-matching placebo

Detailed Description

The study primarily assessed the safety and tolerability (safety run-in Part A) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab, and then, the efficacy (double-blind, randomized, placebo-controlled Part B) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

• Study Type: Interventional
• Enrollment (Actual): 673
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1431FWO
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1426ANZ
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Novartis Investigative Site
  • Queensland
    • Wooloongabba, Queensland, Australia, 4102
      • Novartis Investigative Site
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Novartis Investigative Site
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Novartis Investigative Site
• Austria
  • Salzburg, Austria, 5020
    • Novartis Investigative Site
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Novartis Investigative Site
• Brazil
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784 400
      • Novartis Investigative Site
    • São Paulo, São Paulo, Brazil, 01246 000
      • Novartis Investigative Site
    • São Paulo, São Paulo, Brazil, 04014-002
      • Novartis Investigative Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Novartis Investigative Site
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Novartis Investigative Site
• Chile
  • Santiago, Chile, 8420383
    • Novartis Investigative Site
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4810469
      • Novartis Investigative Site
• China
  • Beijing, China, 100036
    • Novartis Investigative Site
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Novartis Investigative Site
    • Wuhan, Hubei, China, 430022
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410013
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130012
      • Novartis Investigative Site
  • Shanxi
    • Xi’an, Shanxi, China, 710038
      • Novartis Investigative Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Novartis Investigative Site
• Colombia
  • Cesar Department
    • Valledupar, Cesar Department, Colombia, 200001
      • Novartis Investigative Site
• Czechia
  • Brno, Czechia, 656 53
    • Novartis Investigative Site
  • Brno, Czechia, 625 00
    • Novartis Investigative Site
  • Prague, Czechia, 128 08
    • Novartis Investigative Site
  • Vitkovice
    • Ostrava, Vitkovice, Czechia, 703 84
      • Novartis Investigative Site
• Denmark
  • Herning, Denmark, 7400
    • Novartis Investigative Site
• Finland
  • Oulu, Finland, FIN-90220
    • Novartis Investigative Site
• France
  • Lyon, France, 69373
    • Novartis Investigative Site
  • Montpellier, France, 34070
    • Novartis Investigative Site
  • Nantes, France, 44093
    • Novartis Investigative Site
  • Paris, France, 75231
    • Novartis Investigative Site
  • Bouches Du Rhone
    • Marseille, Bouches Du Rhone, France, 13915
      • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Georgsmarienhütte, Germany, 49124
    • Novartis Investigative Site
  • Gerlingen, Germany, 70839
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Novartis Investigative Site
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 51109
      • Novartis Investigative Site
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Novartis Investigative Site
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04347
      • Novartis Investigative Site
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 185 47
    • Novartis Investigative Site
  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
• Hong Kong
  • Kowloon, Hong Kong, 999999
    • Novartis Investigative Site
• Hungary
  • Veszprém, Hungary, 8200
    • Novartis Investigative Site
• Iceland
  • Reykjavik, Iceland, 101
    • Novartis Investigative Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500034
      • Novartis Investigative Site
  • Haryana
    • Gurgaon, Haryana, India, 122 001
      • Novartis Investigative Site
  • Maharashtra
    • Pune, Maharashtra, India, 411013
      • Novartis Investigative Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Novartis Investigative Site
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Novartis Investigative Site
• Italy
  • AV
    • Avellino, AV, Italy, 83100
      • Novartis Investigative Site
  • GE
    • Genova, GE, Italy, 16132
      • Novartis Investigative Site
  • MI
    • Milan, MI, Italy, 20133
      • Novartis Investigative Site
    • Milan, MI, Italy, 20141
      • Novartis Investigative Site
    • Milan, MI, Italy, 20132
      • Novartis Investigative Site
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
  • MO
    • Modena, MO, Italy, 41124
      • Novartis Investigative Site
  • PD
    • Padua, PD, Italy, 35128
      • Novartis Investigative Site
  • PG
    • Perugia, PG, Italy, 06129
      • Novartis Investigative Site
  • PR
    • Parma, PR, Italy, 43126
      • Novartis Investigative Site
  • TO
    • Orbassano, TO, Italy, 10043
      • Novartis Investigative Site
• Japan
  • Osaka, Japan, 5458586
    • Novartis Investigative Site
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464 8681
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608648
      • Novartis Investigative Site
  • Hyōgo
    • Himeji, Hyōgo, Japan, 670-8520
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Novartis Investigative Site
  • Osaka
    • Sakai, Osaka, Japan, 591-8555
      • Novartis Investigative Site
  • Shizuoka
    • Sunto Gun, Shizuoka, Japan, 411 8777
      • Novartis Investigative Site
  • Tokyo
    • Chuo Ku, Tokyo, Japan, 1040045
      • Novartis Investigative Site
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-0241
      • Novartis Investigative Site
• Lebanon
  • Beirut, Lebanon, 166830
    • Novartis Investigative Site
  • Saida, Lebanon, 652
    • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Novartis Investigative Site
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Novartis Investigative Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Novartis Investigative Site
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Novartis Investigative Site
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Novartis Investigative Site
  • Groningen, Netherlands, 9728 NZ
    • Novartis Investigative Site
• Norway
  • Drammen, Norway, 3004
    • Novartis Investigative Site
• Philippines
  • Makati City, Philippines, 1229
    • Novartis Investigative Site
  • Quezon, Philippines, 1102
    • Novartis Investigative Site
  • San Juan City, Philippines, 1502
    • Novartis Investigative Site
  • National Capital Region
    • City of Taguig, National Capital Region, Philippines, 1634
      • Novartis Investigative Site
• Poland
  • Gliwice, Poland, 44 101
    • Novartis Investigative Site
  • Poznan, Poland, 60 569
    • Novartis Investigative Site
  • Tomaszw Mazowiecki, Poland, 97-200
    • Novartis Investigative Site
• Portugal
  • Lisbon, Portugal, 1769 001
    • Novartis Investigative Site
  • Porto, Portugal, 4200-072
    • Novartis Investigative Site
• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Novartis Investigative Site
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • Novartis Investigative Site
• Russia
  • Arkhangelsk, Russia, 163045
    • Novartis Investigative Site
  • Omsk, Russia, 644013
    • Novartis Investigative Site
  • Saint Petersburg, Russia, 192148
    • Novartis Investigative Site
  • Saint Petersburg, Russia, 197022
    • Novartis Investigative Site
  • Saint Petersburg, Russia, 196603
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119228
    • Novartis Investigative Site
  • Singapore, Singapore, S308433
    • Novartis Investigative Site
  • Singapore, Singapore, 168583
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 83310
    • Novartis Investigative Site
  • Kosice-Saca, Slovakia, 958 01
    • Novartis Investigative Site
• South Korea
  • Seoul, South Korea, 05505
    • Novartis Investigative Site
  • Seoul, South Korea, 03722
    • Novartis Investigative Site
  • Seoul, South Korea, 06591
    • Novartis Investigative Site
  • Korea
    • Gyeonggi-do, Korea, South Korea, 10408
      • Novartis Investigative Site
    • Seoul, Korea, South Korea, 03080
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08035
    • Novartis Investigative Site
  • Barcelona, Spain, 08036
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28046
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Madrid, Spain, 28009
    • Novartis Investigative Site
  • Málaga, Spain, 29010
    • Novartis Investigative Site
  • Valencia, Spain, 46026
    • Novartis Investigative Site
  • Zaragoza, Spain, 50009
    • Novartis Investigative Site
  • Andalusia
    • Granada, Andalusia, Spain, 18014
      • Novartis Investigative Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Novartis Investigative Site
  • Gipuzkoa
    • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
      • Novartis Investigative Site
  • Las Palmas
    • Las Palmas de Gran C, Las Palmas, Spain, 35016
      • Novartis Investigative Site
• Sweden
  • Stockholm, Sweden, 171 76
    • Novartis Investigative Site
• Switzerland
  • Basel, Switzerland, 4031
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Novartis Investigative Site
  • Tainan, Taiwan, 704
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Taipei, Taiwan, 11217
    • Novartis Investigative Site
  • Taoyuan District, Taiwan, 333
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10330
    • Novartis Investigative Site
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Hat Yai
    • Songkhla, Hat Yai, Thailand, 90110
      • Novartis Investigative Site
  • THA
    • Khon Kaen, THA, Thailand, 40002
      • Novartis Investigative Site
• Turkey (Türkiye)
  • Bagcilar
    • Istanbul, Bagcilar, Turkey (Türkiye), 34214
      • Novartis Investigative Site
  • Bilkent Cankaya
    • Ankara, Bilkent Cankaya, Turkey (Türkiye), 06800
      • Novartis Investigative Site
  • Merkez
    • Edirne, Merkez, Turkey (Türkiye), 22030
      • Novartis Investigative Site
  • Sihhiye-Altindag
    • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
      • Novartis Investigative Site
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Novartis Investigative Site
  • Manchester, United Kingdom, M20 2BX
    • Novartis Investigative Site
  • Plymouth, United Kingdom, PL6 8DH
    • Novartis Investigative Site
  • Newcastle Upon Tyne
    • High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Novartis Investigative Site
• United States
  • California
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Los Angeles, California, United States, 90033
      • USC Kenneth Norris Comprehensive Cancer Center
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
• Vietnam
  • Hanoi, Vietnam, 100000
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key inclusion criteria:

• Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
• Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.
• Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
• At least 1 measurable lesion by RECIST 1.1

Key exclusion criteria:

• Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
• Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
• Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.
• Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
• Subject with suspected or proven immune-compromised state or infections.
• Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Cohort A; Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.	Drug: pembrolizumab; 200 mg every 3 weeks (squamous and non-squamous); Drug: carboplatin; Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous); Drug: canakinumab; canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous); Other Names: ACZ885; Drug: pemetrexed; 500 mg/m^2 every 3 weeks (non-squamous)
Experimental: Part 1: Cohort B; Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.	Drug: pembrolizumab; 200 mg every 3 weeks (squamous and non-squamous); Drug: canakinumab; canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous); Other Names: ACZ885; Drug: pemetrexed; 500 mg/m^2 every 3 weeks (non-squamous); Drug: cisplatin; 75 mg/m^2 every 3 weeks (non-squamous)
Experimental: Part 1: Cohort C; Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.	Drug: pembrolizumab; 200 mg every 3 weeks (squamous and non-squamous); Drug: carboplatin; Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous); Drug: canakinumab; canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous); Other Names: ACZ885; Drug: paclitaxel; 200 mg/m^2 every 3 weeks (squamous)
Experimental: Part 2: Canakinumab+pembro+CTx; Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.	Drug: pembrolizumab; 200 mg every 3 weeks (squamous and non-squamous); Drug: carboplatin; Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous); Drug: canakinumab; canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous); Other Names: ACZ885; Drug: pemetrexed; 500 mg/m^2 every 3 weeks (non-squamous); Drug: cisplatin; 75 mg/m^2 every 3 weeks (non-squamous); Drug: paclitaxel; 200 mg/m^2 every 3 weeks (squamous); Drug: nab-paclitaxel; 100 mg/m^2 on Days 1, 8, and 15 of every cycle (squamous)
Other: Part 2: Placebo+pembro+CTx; Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.	Drug: pembrolizumab; 200 mg every 3 weeks (squamous and non-squamous); Drug: carboplatin; Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous); Drug: pemetrexed; 500 mg/m^2 every 3 weeks (non-squamous); Drug: cisplatin; 75 mg/m^2 every 3 weeks (non-squamous); Drug: paclitaxel; 200 mg/m^2 every 3 weeks (squamous); Drug: nab-paclitaxel; 100 mg/m^2 on Days 1, 8, and 15 of every cycle (squamous); Drug: canakinumab-matching placebo; canakinumab placebo every 3 weeks (squamous and non-squamous)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)	A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.	During the first 42 days of dosing
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1	Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.	18 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1	Overall survival is defined as the time from date of randomization to date of death due to any cause.	Up to approximately 32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1	ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1	ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 26 months
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1	Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.	Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1	Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.	Up to approximately 26 months
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1	Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1	Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 26 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1	Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 26 months
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab	Participants with at least one ADA-positive sample.	Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab	Participants with at least one ADA-positive sample.	Up to approximately 26 months
Part 1 (Safety run-in): Antidrug Antibodies (ADAs) of Pembrolizumab	Participants with at least one ADA-positive sample.	Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab	Participants with at least one ADA-positive sample.	Up to approximately 26 months
Part 1 (Safety Run-in): Serum Canakinumab Concentration		Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration		Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration		Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration		Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration		Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration		Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Cisplatin Concentration		Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration		Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)
Part 1 (Safety Run-in): Plasma Carboplatin Concentration		Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration		Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration		Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration		Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration		Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.	Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire	The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 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 range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.	Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire	The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline	Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS)	The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline	Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980. Epub 2023 Dec 1.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cisplatin; NSCLC; non-small cell lung cancer; paclitaxel; carboplatin; PD-L1; metastatic; nab-paclitaxel; pembrolizumab; non small cell lung cancer; pemetrexed; hsCRP; ACZ885; locally advanced; canakinumab; squamous; non-squamous; IL-1β; CANOPY; first line therapy; CANOPY-1; platinum-based doublet chemotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; pembrolizumab; 130-nm albumin-bound paclitaxel; canakinumab
• Other Study ID Numbers: CACZ885U2301; 2024-511490-29-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No