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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03626545




Registration number
NCT03626545
Ethics application status
Date submitted
25/07/2018
Date registered
13/08/2018

Titles & IDs
Public title
Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)
Secondary ID [1] 0 0
2018-002480-26
Secondary ID [2] 0 0
CACZ885V2301
Universal Trial Number (UTN)
Trial acronym
CANOPY-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Canakinumab
Treatment: Drugs - Docetaxel
Other interventions - Placebo

Experimental: Safety run-in part: Canakinumab+docetaxel - Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1). Subjects were assessed for at least 2 complete cycles of treatment (21 days per cycle; a total of 42 days) for safety evaluation (DLT) to define RP3R. De-escalation to canakinumab 200 mg subcutaneous every 6 weeks + docetaxel 75 mg/m\^2, every 3 weeks could also be considered.

Experimental: Randomized part: Canakinumab + docetaxel - Participants were treated with canakinumab subcutaneous at RP3R and docetaxel at 75 mg/m\^2 every 3 weeks

Placebo comparator: Randomized part: Placebo + docetaxel - Participants were treated with placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 every 3 weeks


Treatment: Drugs: Canakinumab
Canakinumab, 200 mg, subcutaneous. The initial dose regimen was once every 3 weeks (on Day 1 of each 21-day cycle)

Treatment: Drugs: Docetaxel
Docetaxel 75mg/m\^2, intravenous, administered on Day 1 of each 21-day cycle

Other interventions: Placebo
Placebo, sub-cutaneous, admnistered at the RP3R defined in Part 1-safety run-in.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
During the first 42 days of dosing
Primary outcome [2] 0 0
Randomized Part: Overall Survival (OS)
Timepoint [2] 0 0
From randomization until death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approximately (approx.) 18 months)
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 10 months for the safety run-in part and 18 months for the randomized part)
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
From first documented response of CR or PR to date of first documented progression, death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approx. 10 months for the safety run-in and 18 months for the randomized)
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 10 months for the safety run-in part and 18 months for the randomized part)
Secondary outcome [4] 0 0
Randomized Part: Progression-Free Survival (PFS)
Timepoint [4] 0 0
From randomization until disease progression, death or final analysis data cutoff date (08-Jan-2021) whichever comes first (assessed up to approx. 18 months)
Secondary outcome [5] 0 0
Randomized Part: Time to Response (TTR)
Timepoint [5] 0 0
From randomization until first documented response or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approx. 18 months)
Secondary outcome [6] 0 0
Randomized Part: Time to Definitive 10-point Deterioration (TTD) Symptom Scores of Chest Pain, Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Lung Cancer (LC13) Questionnaire
Timepoint [6] 0 0
From baseline through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 18 months)
Secondary outcome [7] 0 0
Randomized Part: Time to Definitive 10-point Deterioration in Global Health Status (GHS)/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
Timepoint [7] 0 0
From baseline through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 18 months)
Secondary outcome [8] 0 0
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire
Timepoint [8] 0 0
Baseline, every 3 weeks from Week 3 until end of treatment, every 6 or 12 weeks post-treatment until progression (post-treatment efficacy visits), 7 and 28 days post progression through final analysis cutoff date of 08Jan2021 (up to approx. 18 months)
Secondary outcome [9] 0 0
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire
Timepoint [9] 0 0
Baseline, every 3 weeks from Week 3 until end of treatment, every 6 or 12 weeks post-treatment until progression (post-treatment efficacy visits), 7 and 28 days post progression through final analysis cutoff date of 08Jan2021 (up to approx. 18 months)
Secondary outcome [10] 0 0
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Timepoint [10] 0 0
Baseline, every 3 weeks from Week 3 until end of treatment, every 6 or 12 weeks post-treatment until progression (post-treatment efficacy visits), 7 and 28 days post progression through final analysis cutoff date of 08Jan2021 (up to approx. 18 months)
Secondary outcome [11] 0 0
Safety run-in Part: Maximum Plasma Concentration (Cmax) of Canakinumab
Timepoint [11] 0 0
Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days
Secondary outcome [12] 0 0
Safety run-in Part: Time of Maximum Plasma Concentration (Tmax) of Canakinumab
Timepoint [12] 0 0
Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days
Secondary outcome [13] 0 0
Safety run-in Part: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Canakinumab
Timepoint [13] 0 0
Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days
Secondary outcome [14] 0 0
Safety run-in Part: Cmax of Docetaxel
Timepoint [14] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days
Secondary outcome [15] 0 0
Safety run-in Part: Tmax of Docetaxel
Timepoint [15] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days
Secondary outcome [16] 0 0
Safety run-in Part: AUClast of Docetaxel
Timepoint [16] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days
Secondary outcome [17] 0 0
Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab
Timepoint [17] 0 0
Pre-dose on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1 and Cycle 18 Day 1. Each cycle is 21 days.
Secondary outcome [18] 0 0
Randomized Part: Cmax of Docetaxel
Timepoint [18] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days
Secondary outcome [19] 0 0
Randomized Part: Tmax of Docetaxel
Timepoint [19] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days
Secondary outcome [20] 0 0
Randomized Part: AUClast of Docetaxel
Timepoint [20] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days
Secondary outcome [21] 0 0
Randomized Part: Canakinumab Antidrug Antibodies (ADA) at Baseline
Timepoint [21] 0 0
Baseline
Secondary outcome [22] 0 0
Randomized Part: Canakinumab ADA Incidence On-treatment
Timepoint [22] 0 0
Pre-dose at Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1 , end of treatment, and 130 days after end of treatment through final analysis data cutoff date of 08-Jan-2021 (assessed up to 18 months). Each cycle is 21 days

Eligibility
Key inclusion criteria
Key

* Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
* Subject had received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
* Subject with ECOG performance status (PS) of 0 or 1.
* Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject who previously received docetaxel, canakinumab (or another IL-1ß inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
* Subject with EGFRor ALK positive tumor.
* History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2021
Sample size
Target
Accrual to date
Final
245
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Greenslopes
Recruitment hospital [2] 0 0
Novartis Investigative Site - Shepparton
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
3630 - Shepparton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
La Rioja
Country [9] 0 0
Argentina
State/province [9] 0 0
Santiago del Estero
Country [10] 0 0
Belgium
State/province [10] 0 0
Oost Vlaanderen
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Charleroi
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
Roeselare
Country [15] 0 0
Brazil
State/province [15] 0 0
BA
Country [16] 0 0
Brazil
State/province [16] 0 0
RS
Country [17] 0 0
Brazil
State/province [17] 0 0
SC
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
Country [21] 0 0
China
State/province [21] 0 0
Sichuan
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno - Bohunice
Country [24] 0 0
Czechia
State/province [24] 0 0
Ostrava Vitkovice
Country [25] 0 0
Denmark
State/province [25] 0 0
Herlev
Country [26] 0 0
Denmark
State/province [26] 0 0
Odense C
Country [27] 0 0
France
State/province [27] 0 0
Cedex 09
Country [28] 0 0
France
State/province [28] 0 0
Besancon Cedex
Country [29] 0 0
France
State/province [29] 0 0
Bordeaux Cedex
Country [30] 0 0
France
State/province [30] 0 0
Bron
Country [31] 0 0
France
State/province [31] 0 0
Strasbourg Cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Dresden
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt
Country [35] 0 0
Germany
State/province [35] 0 0
Gerlingen
Country [36] 0 0
Germany
State/province [36] 0 0
Grosshansdorf
Country [37] 0 0
Germany
State/province [37] 0 0
Koeln
Country [38] 0 0
Germany
State/province [38] 0 0
Ulm
Country [39] 0 0
Greece
State/province [39] 0 0
Heraklion Crete
Country [40] 0 0
Greece
State/province [40] 0 0
Thessaloniki
Country [41] 0 0
Hungary
State/province [41] 0 0
Pest
Country [42] 0 0
Israel
State/province [42] 0 0
Ramat Gan
Country [43] 0 0
Italy
State/province [43] 0 0
LU
Country [44] 0 0
Italy
State/province [44] 0 0
MI
Country [45] 0 0
Italy
State/province [45] 0 0
PN
Country [46] 0 0
Japan
State/province [46] 0 0
Aichi
Country [47] 0 0
Japan
State/province [47] 0 0
Hyogo
Country [48] 0 0
Japan
State/province [48] 0 0
Kanagawa
Country [49] 0 0
Japan
State/province [49] 0 0
Tokyo
Country [50] 0 0
Japan
State/province [50] 0 0
Osaka
Country [51] 0 0
Jordan
State/province [51] 0 0
Amman
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seocho Gu
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Lebanon
State/province [54] 0 0
Ashrafieh
Country [55] 0 0
Netherlands
State/province [55] 0 0
Amsterdam
Country [56] 0 0
Netherlands
State/province [56] 0 0
Groningen
Country [57] 0 0
Netherlands
State/province [57] 0 0
Maastricht
Country [58] 0 0
Poland
State/province [58] 0 0
Gdansk
Country [59] 0 0
Poland
State/province [59] 0 0
Rzeszow
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Pushkin Saint Petersburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
St Petersburg
Country [63] 0 0
Singapore
State/province [63] 0 0
Singapore
Country [64] 0 0
Spain
State/province [64] 0 0
Andalucia
Country [65] 0 0
Spain
State/province [65] 0 0
Catalunya
Country [66] 0 0
Spain
State/province [66] 0 0
Comunidad Valenciana
Country [67] 0 0
Spain
State/province [67] 0 0
Galicia
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Taiwan
State/province [69] 0 0
Tainan
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03626545