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Trial details
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 (CANOPY-2)
Current status:
Approved
|
Date registered:
04/01/2021
Trial version(s)
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
History: 20/02/2019
Current: 20/02/2019
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Main Information
Primary registry identifying number
LBCTR2019030199
Protocol number
CACZ885V2301
MOH registration number
q34124
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
12/12/2019
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
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 (CANOPY-2)
Acronym
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)
Acronym
Brief summary of the study: English
This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.
Brief summary of the study: Arabic
دراسة مرحلة ثالثة عشوائيّة التوزيع مزدوجة التعمية مرتكزة على المقارنة بدواء وهميّ لتقييم فعاليّة وسلامة دواء كاناكينوماب بالاشتراك مع دوسيتاكسيل مقابل الدواء الوهمي مع دوسيتاكسيل لدى المرضى المصابين بسرطان الرئة ذي الخلايا غير الصغيرة المعالجين سابقًا بمثبّطات PD(L)1 وبالعلاج الكيميائي القائم على البلاتين (كانوبي-2) (CANOPY-2)
Health conditions/problem studied: Specify
Non Small Cell Lung Cancer (NSCLC)
Interventions: Specify
Camakinumab (ACZ885) plus Docetaxel vs Palcebo Plus Docetaxel
Key inclusion and exclusion criteria: Inclusion criteria
•Histologically confirmed advanced (stage IIIB) or metastatic NSCLC. •Subject has 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 inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
90
Key inclusion and exclusion criteria: Exclusion criteria
•Subject who previously received docetaxel, canakinumab (or another IL-1β 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. Other protocol-defined inclusion/exclusion may apply.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Efficacy and safety
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
Argentina, Australia, Canada, Belgium, Bahrain, Brazil, Chile, Austria, Denmark, France, Germany, India, Italy, Japan...
Name of IMP
Canakinumab (ACZ885)
Type of IMP
Immunological
Pharmaceutical class
Monoclonal Antibody
Therapeutic indication
subjects with non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy
Therapeutic benefit
Progression-Free Survival (PFS)
Biospecimen retention
Samples with DNA**
Biospecimen description
Lab specimen and tissue will be shipped to Quintiles (Q2) Central Lab in the UK Blood will include hematology, biochemistry and blood for circulating tumor DNA
Target sample size
8
Actual enrollment target size
3
Date of first enrollment: Type
Actual
Date of first enrollment: Date
28/08/2019
Date of study closure: Type
Actual
Date of study closure: Date
20/10/2020
Recruitment status
Complete
Date of completion
04/03/2020
IPD sharing statement plan
No
IPD sharing statement 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.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03626545?term=cacz885v2301&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
ClinicalTrials.gov
NCT03626545
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Joseph
Kattan
Beirut
Lebanon
03 635 913
jkattan62@hotmail.com
Hotel Dieu De France
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Fadi
Farhat
Saida
Lebanon
03 753 155
drfadi.trials@gmail.com
Hammoud Hospital University Medical Center
Public
Fadi
El karak
Beirut
Lebanon
961 3 061 621
felkarak@yahoo.com
Bellevue Medical Center
Public
Anas
Mugharbil
Beirut
Lebanon
03 776 142
anasml@hotmail.com
Makassed General Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr Joseph Kattan
Hematology Oncology
Approved
Hammoud Hospital University Medical Center
Dr Fadi Farhat
Hematology Oncology
Approved
Bellevue Medical Center
Dr Fadi El Karak
Hematology Oncology
Approved
Makassed General Hospital
Dr Anas Mugharbil
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
21/12/2018
Sami Richa
cue@usj.edu.lb
961421229
Hammoud Hospital University Medical Center
20/12/2018
Ahmad Zaatari
zaatari@hammoudhospital.com
00961 (0) 7 723111 ext 1160
Bellevue Medical Center
21/12/2018
Ghassan Maalouf
gmaalouf@bmc.com.lb
01 682666 ext 5006
Makassed General Hospital
30/04/2019
Mariam Rajab
Research.makassed@hotmail.com
01636941
Countries of Recruitment
Name
Lebanon
Belgium
France
Germany
Japan
Singapore
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Non Small Cell Lung Cancer (NSCLC)
Bronchus or lung, unspecified (C34.9)
NSCLC
Interventions
Intervention
Description
Keyword
Blood test (Hematology, Chemistry, Coagulation, PK, ct DNA, Biomarkers...), CT Scan, MRI, Whole body bone scan, Skin photography, Vital signs, Physical exam, Urinalysis, X-Ray
Blood test (Hematology, Chemistry, Coagulation, PK, ct DNA, Biomarkers...), CT Scan, MRI, Whole body bone scan, Skin photography, Vital signs, Physical exam, Urinalysis, X-Ray
ICF, IMP, Lab tests
Primary Outcomes
Name
Time points
Measure
Incidence of dose limiting toxicities (DLTs)
6 months
6 months
Overall Survival (OS)
Randomization till 26 Months
Randomization till 26 Months
Key Secondary Outcomes
Name
Time points
Measure
•Overall response rate (ORR)
every 6 weeks
every 6 weeks
•Duration of response (DOR)
every 6 weeks
every 6 weeks
•Disease control rate (DCR)
every 6 weeks
every 6 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Annual 2020 -IB-PA2 HDF
27/12/2020
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