Study Stopped
Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns
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)
2 other identifiers
interventional
673
40 countries
150
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Dec 2018
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
December 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2021
CompletedResults Posted
Study results publicly available
October 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2026
CompletedFebruary 25, 2026
February 1, 2026
2.6 years
August 6, 2018
July 5, 2024
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (28)
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
Up to approximately 26 months
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Up to approximately 26 months
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Up to approximately 25 months
- +23 more secondary outcomes
Study Arms (5)
Part 1: Cohort A
EXPERIMENTALSafety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
Part 1: Cohort B
EXPERIMENTALSafety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Part 1: Cohort C
EXPERIMENTALSafety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Part 2: Canakinumab+pembro+CTx
EXPERIMENTALDouble-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Part 2: Placebo+pembro+CTx
OTHERDouble-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Interventions
canakinumab placebo every 3 weeks (squamous and non-squamous)
Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)
75 mg/m\^2 every 3 weeks (non-squamous)
200 mg/m\^2 every 3 weeks (squamous)
100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)
500 mg/m\^2 every 3 weeks (non-squamous)
canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)
200 mg every 3 weeks (squamous and non-squamous)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (152)
Pacific Shores Medical Group
Long Beach, California, 90813, United States
USC Kenneth Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
AdventHealth
Orlando, Florida, 32804, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Caba, Buenos Aires, C1426ANZ, Argentina
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Caba, C1431FWO, Argentina
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Westmead, New South Wales, 2145, Australia
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Wooloongabba, Queensland, 4102, Australia
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Melbourne, Victoria, 3000, Australia
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Murdoch, Western Australia, 6150, Australia
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Linz, Upper Austria, 4020, Austria
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Salzburg, 5020, Austria
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Barretos, São Paulo, 14784 400, Brazil
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São Paulo, São Paulo, 01246 000, Brazil
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São Paulo, São Paulo, 04014-002, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Temuco, Región de la Araucanía, 4810469, Chile
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Santiago, 8420383, Chile
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Harbin, Heilongjiang, 150081, China
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Wuhan, Hubei, 430022, China
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Valledupar, Cesar Department, 200001, Colombia
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Ostrava, Vitkovice, 703 84, Czechia
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Brno, 625 00, Czechia
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Related Publications (1)
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.
PMID: 38039427DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 15, 2018
Study Start
December 21, 2018
Primary Completion
August 9, 2021
Study Completion
January 26, 2026
Last Updated
February 25, 2026
Results First Posted
October 8, 2024
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.