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 is 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 subjects.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: canakinumab; Drug: pembrolizumab; Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: nab-paclitaxel; Drug: pemetrexed; Drug: canakinumab matching placebo

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

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, 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
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, A 4020
      • Novartis Investigative Site
• Brazil
  • SP
    • Barretos, SP, Brazil, 14784 400
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 01246 000
      • Novartis Investigative Site
    • Sao Paulo, SP, 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 1Z6
      • Novartis Investigative Site
• Chile
  • Santiago, Chile, 8420383
    • Novartis Investigative Site
  • Region De La Araucania
    • Temuco, Region De La Araucania, 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
    • Valledupar, Cesar, Colombia, 5602310
      • Novartis Investigative Site
• Czechia
  • Brno - Bohunice, Czechia, 625 00
    • Novartis Investigative Site
  • Ostrava Vitkovice, Czechia, 703 84
    • Novartis Investigative Site
  • Czech Republic
    • Brno, Czech Republic, Czechia, 656 53
      • Novartis Investigative Site
    • Prague 2, Czech Republic, Czechia, 128 00
      • 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
  • Paris, France, 75231
    • Novartis Investigative Site
  • Saint Herblain, France, 44800
    • Novartis Investigative Site
  • Bouches Du Rhone
    • Marseille cedex 20, Bouches Du Rhone, France, 13915
      • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Georgsmarienhuette, Germany, 49124
    • Novartis Investigative Site
  • Gerlingen, Germany, 70839
    • Novartis Investigative Site
  • Gottingen, Germany, 37075
    • Novartis Investigative Site
  • Halle (Saale), Germany, 06120
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Koeln, Germany, 50937
    • Novartis Investigative Site
  • Koeln, Germany, 51109
    • Novartis Investigative Site
  • Leipzig, Germany, D-04347
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Novartis Investigative Site
• Greece
  • Athens, Greece, 18547
    • Novartis Investigative Site
  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
• Hong Kong
  • Kowloon, Hong Kong
    • Novartis Investigative Site
• Hungary
  • Veszprem, Hungary, 8200
    • Novartis Investigative Site
• Iceland
  • Reykjavik, Iceland, IS-101
    • Novartis Investigative Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 034
      • 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
    • Milano, MI, Italy, 20133
      • Novartis Investigative Site
    • Milano, MI, Italy, 20132
      • Novartis Investigative Site
    • Milano, MI, Italy, 20141
      • Novartis Investigative Site
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
  • MO
    • Modena, MO, Italy, 41100
      • Novartis Investigative Site
  • PD
    • Padova, PD, Italy, 35100
      • Novartis Investigative Site
  • PG
    • Perugia, PG, Italy, 06129
      • Novartis Investigative Site
  • PR
    • Parma, PR, Italy, 43100
      • Novartis Investigative Site
  • TO
    • Orbassano, TO, Italy, 10043
      • Novartis Investigative Site
• Japan
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Aichi
    • Nagoya, Aichi, Japan, 464 8681
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo city, Hokkaido, Japan, 060 8648
      • Novartis Investigative Site
  • Hyogo
    • Himeji, Hyogo, Japan, 670-8520
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama-city, 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, 104 0045
      • Novartis Investigative Site
  • Yamaguchi
    • Ube-city, Yamaguchi, Japan, 755-0241
      • Novartis Investigative Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05505
    • Novartis Investigative Site
  • Korea
    • Gyeonggi do, Korea, Korea, Republic of, 10408
      • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Lebanon
  • Ashrafieh, Lebanon, 166830
    • Novartis Investigative Site
  • Saida, Lebanon, 652
    • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Novartis Investigative Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Novartis Investigative Site
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Novartis Investigative Site
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • 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, 1500
    • Novartis Investigative Site
  • Metro Manila
    • Taguig City, Metro Manila, 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
  • Lisboa, Portugal, 1769-001
    • Novartis Investigative Site
  • Porto, Portugal, 4200-072
    • Novartis Investigative Site
• Romania
  • Cluj-Napoca, Romania, 400124
    • Novartis Investigative Site
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • Novartis Investigative Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Novartis Investigative Site
  • Omsk, Russian Federation, 644013
    • Novartis Investigative Site
  • Pushkin Saint Petersburg, Russian Federation, 196603
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 192148
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119228
    • Novartis Investigative Site
  • Singapore, Singapore, 308433
    • Novartis Investigative Site
  • Singapore, Singapore, 168583
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 83310
    • Novartis Investigative Site
  • Partizanske, Slovakia, 958 03
    • Novartis Investigative Site
• Spain
  • Las Palmas De Gran Canarias, Spain, 35016
    • 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
  • Valencia, Spain, 46026
    • Novartis Investigative Site
  • Zaragoza, Spain, 50009
    • Novartis Investigative Site
  • Andalucia
    • Granada, Andalucia, Spain, 18014
      • Novartis Investigative Site
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
  • Catalunya
    • Badalona, Catalunya, Spain, 08916
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08035
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
  • Pais Vasco
    • San Sebastian, Pais Vasco, Spain, 20080
      • Novartis Investigative Site
• Sweden
  • Stockholm, Sweden, 171 76
    • Novartis Investigative Site
• Switzerland
  • Basel, Switzerland, 4031
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Novartis Investigative Site
  • Tainan, Taiwan, 704
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Taipei, Taiwan, 11217
    • Novartis Investigative Site
  • Taoyuan, 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
  • Ankara, Turkey, 06100
    • Novartis Investigative Site
  • Edirne, Turkey, 22030
    • Novartis Investigative Site
  • Istanbul, Turkey, 34214
    • 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
      • Advent Health Cancer Institute
  • 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: canakinumab; canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy	Drug: canakinumab; canakinumab every 3 weeks (squamous and non-squamous); Other Names: ACZ885; 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: cisplatin; 75 mg/m2 every 3 weeks (non-squamous); Drug: paclitaxel; 200 mg/m2 every 3 weeks (squamous); Drug: nab-paclitaxel; 100 mg/m2 every 3 weeks (squamous); Drug: pemetrexed; 500 mg/m2 every 3 weeks (non-squamous)
Other: canakinumab matching-placebo; 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: cisplatin; 75 mg/m2 every 3 weeks (non-squamous); Drug: paclitaxel; 200 mg/m2 every 3 weeks (squamous); Drug: nab-paclitaxel; 100 mg/m2 every 3 weeks (squamous); Drug: pemetrexed; 500 mg/m2 every 3 weeks (non-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
Safety run-in part: Incidence of dose limiting toxicities (DLTs)	Incidence of DLTs assessed among at least 6 evaluable subjects during the first 42 days of study treatment	6 months from start of safety run-in part
Double-blind, randomized, placebo-controlled part: Progression free survival (PFS) per investigator assessment using RECIST v1.1	Progression free survival is 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 from start of randomization part
Double-blind, randomized, placebo-controlled part: 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	38 months from start of randomization part

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety run-in part: Overall response rate (ORR) per investigator assessment using RECIST v1.1	ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 6 months
Double-blind, randomized, placebo-controlled part : Overall response rate (ORR) per investigator assessment using RECIST v1.1	ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Safety run-in part: Disease control rate (DCR) per investigator assessment using RECIST v1.1	Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 6 months
Double-blind, randomized, placebo-controlled part : Disease control rate (DCR) per investigator assessment using RECIST v1.1	Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Safety run-in part: Duration of response (DOR) per investigator assessment using RECIST v1.1	Duration of response is 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	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 6 months
Double-blind, randomized, placebo-controlled part : Duration of response (DOR) per investigator assessment using RECIST v1.1	Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Double-blind, randomized, placebo-controlled part only: Time to response (TTR) per investigator assessment using RECIST v1.1	Time to response (TTR) is 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	Baseline, every 6 weeks (for the first 12 weeks), then every 9 weeks (for the next 21 weeks) and every 12 weeks thereafter until progression per investigator assessment and up to 18 months
Safety run-in part: Antidrug antibodies (ADA) of canakinumab		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
Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of canakinumab		Predose (0 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
Safety run-in part: Antidrug antibodies (ADA) of pembrolizumab		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
Double-blind, randomized, placebo-controlled part : Antidrug antibodies (ADA) of pembrolizumab		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
Safety run-in part: 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)
Double-blind, randomized, placebo-controlled part : 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)
Safety run-in part: 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)
Double-blind, randomized, placebo-controlled part : 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)
Safety run-in part: 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)
Double-blind, randomized, placebo-controlled part : : 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)
Safety run-in part: 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)
Double-blind, randomized, placebo-controlled part: 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)
Safety run-in part: 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)
Double-blind, randomized, placebo-controlled part: 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)
Safety run-in part: 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)
Double-blind, randomized, placebo-controlled part: 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)
Double-blind, randomized, placebo-controlled part: 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)
Double-blind, randomized, placebo-controlled part only :Time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea per EORTC QLQ-LC13 questionnaire	To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)	Baseline and at day 1 of every visit (with dosing or not) until end of treatment, before each tumor assessments and 2 times (7 days and 28 days) after disease progression and up to 18 months
Double-blind, randomized, placebo-controlled part only: Time to definitive deterioration in global health status/quality of life, shortness of breath and pain per EORTC QLQ-C30 questionnaire	To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30)	Baseline and at day 1 of every visit (with dosing or not) until end of treatment, before each tumor assessments and 2 times (7 days and 28 days) after disease progression and up to 18 months
Double-blind, randomized, placebo-controlled part only: change from baseline in score as per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire	To assess the effect of canakinumab versus placebo on patient reported outcomes ((PROs) - patient's health related quality of life)	Baseline and at day 1 of every visit (with dosing or not) until end of treatment, before each tumor assessments and 2 times (7 days and 28 days) after disease progression and up to 18 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): August 9, 2021
• Study Completion (Estimated): June 7, 2027

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): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

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: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Carboplatin; Paclitaxel; Pembrolizumab; Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Pemetrexed
• Other Study ID Numbers: CACZ885U2301; 2018-001547-32 (EudraCT 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