LBCTR : Trial details

Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Current status: Approved | Date registered: 17/12/2019 | Date last updated: 13/12/2019

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Main Information

Primary registry identifying number

LBCTR2019040221

Protocol number

CACZ885T2301

MOH registration number

7981/2018

Trial already registered with the MoPH

Study registered at the country of origin

Type of registration

Retrospective

Type of registration: Justify

LCTR was recently initiated, original file was previously submitted by Paper

Date of registration in national regulatory agency

22/02/2018

Primary sponsor

Novartis Pharma Services Inc.

Primary sponsor: Country of origin

Novartis Pharmaceuticals

Public title

Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Acronym

Scientific title

A phase III, multicenter, randomized, double blind, placebocontrolled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)

Acronym

Brief summary of the study: English

The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

Brief summary of the study: Arabic

دراسة مرحلة ثالثة متعددة المراكز وعشوائيّة التوزيع ومزدوجة التعمية ومراقبة الدواء الوهمي لتقييم فعاليّة وسلامة دواء كاناكينوماب Canakinumab مقابل الدواء الوهمي كعلاج مساعد لدى مرضى بالغين مصابين بسرطان الرئة غير ذي الخلايا الصغيرة المستأصل كليًا في مراحل AJCC/UICC v. 8 II-IIIA و IIIB (T>5cm N2)

Health conditions/problem studied: Specify

Non-Small Cell Lung Cancer

Interventions: Specify

•Drug: Canakinumab Canakinumab will be administered periodically for approximately 54 weeks. Other Name: ACZ885 •Drug: Placebo Placebo will be administered periodically for approximately 54 weeks.

Key inclusion and exclusion criteria: Inclusion criteria

•Written informed consent must be obtained prior to any screening procedures •Subjects must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy are allowed to enter the study •ECOG performance status (PS) of 0 or 1

Key inclusion and exclusion criteria: Gender

Both

Key inclusion and exclusion criteria: Age minimum

Key inclusion and exclusion criteria: Age maximum

Key inclusion and exclusion criteria: Exclusion criteria

•Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery •Subjects who received neoadjuvant chemotherapy or neoadjuvant radiotherapy •Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer > 3 years. •Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results) •Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible. •Subjects with suspected or proven immunocompromised state as described in the protocol •Live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).

Type of Study

Type

Interventional

Type of intervention

Pharmaceutical

Trial scope

Therapy

Trial scope: Specify scope

Study design: Allocation

Randomized controlled trial

Study design: Masking

Blinded (masking used)

Study design: Control

Placebo

Study phase

Study design: Purpose

Treatment

Study design: Assignment

Single

IMP has market authorization

Yes, Worldwide

IMP has market authorization: Specify the countries

United Kingdom, United States, United Arab Emirates, Saudi Arabia, Sweden, Spain, Russia, Portugal, Japan, Greece, France, Canada, Brazil,

Name of IMP

Canakinumab

Type of IMP

Immunological

Pharmaceutical class

Anti-Inflammatory

Therapeutic indication

Non Small Cell Lung cancer

Therapeutic benefit

Disease free survival

Biospecimen retention

Samples with DNA**

Biospecimen description

DNA tumor circulating DNA, hematology, chemistry, urinalysis PK and PD are shipped to central lab Q2 Edinburgh, UK

Target sample size

Actual enrollment target size

Date of first enrollment: Type

Actual

Date of first enrollment: Date

08/10/2018

Date of study closure: Type

Actual

Date of study closure: Date

15/09/2025

Recruitment status

Recruiting

Date of completion

15/09/2020

IPD sharing statement plan

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.

Additional data URL

https://clinicaltrials.gov/ct2/show/record/NCT03447769?term=ACZ885&cntry=LB&rank=1&view=record

Summary Results

Secondary Identifying Numbers

Full name of issuing authority	Secondary identifying number
Clinicaltrials.gov	NCT03447769

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	03635913	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	03753155	drfadi.trials@gmail.com	Hammoud Hospital UniversityMedical Center
Public	Fadi	El karak	Beirut	Lebanon	71061621	felkarak@yahoo.com	Bellevue Medical Center
Public	Dany	Abi Gerges	Bsalim	Lebanon	03341960	abigerges@idm.net.lb	Middle East Institute Of Health
Public	Mona	Ayoubi	Tripoli	Lebanon	03280069	ayoubi_mona@hotmail.com	Nini Hospital
Public	Jawad	Makarem	Alchouf	Lebanon	03484288	Jawad.Makarem@awmedicalvillage.org	Ainwazein Medical Village

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
Middle East Institute of Health	Dr Dany Abi gerges	Hematology Oncology	Approved
Nini Hospital	Dr Mona Ayoubi	Hematology Oncology	Approved
Ainwazein Medical Village	Dr Jawad Makarem	Hematology Oncology	Approved

Ethics Review

Ethics approval obtained	Approval date	Contact name	Contact email	Contact phone
Hotel Dieu de France	27/02/2018	Nancy Alam	nancy.alam@usj.edu.lb	961 (0) 1 421000 ext 2335
Bellevue Medical Center	05/03/2018	Ghassan Maalouf	gmaalouf@bmc.com.lb	961 (0) 1 682666 ext 7600
Ain w Zein Medical Village	16/02/2018	Khaled Abdel Baki	Khaled.abdelbaki@awmedicalvillage.org	961 (0) 5 509 001 ext 2000
Middle East Institute of Health	16/08/2018	Ahmad Ibrahim	ahmad_O_Ibrahim@hotmail.com	961 (0) 3 233 560
Nini Hospital	15/05/2018	Nabil Kabbara	Nabil.kabbara@hopitalnini.com	961 (0) 6 431 400 ext 1062
Hammoud Hospital University Medical Center	05/02/2018	Ahmad Zaatari	zaatari@hammoudhospital.com	961 (0) 7 723111 ext 1160

Countries of Recruitment

Name
Lebanon
Argentina
Austria
Bulgaria
Chile
France
Germany
India
Turkey
Jordan
United Kingdom
United States of America

Health Conditions or Problems Studied

Condition	Code	Keyword
Non Small Cell Lung Cancer	Bronchus or lung, unspecified (C34.9)	NSCLC

Interventions

Intervention	Description	Keyword
Lab, radiology, ICF , IMP administration	Lab, radiology, ICF , IMP administration	Lab, radiology, ICF , IMP administration

Primary Outcomes

Name	Time points	Measure
Disease Free Survival	5 years	5 years

Key Secondary Outcomes

Name	Time points	Measure
Overall Survival (OS)	5 years	5 years
•Lung Cancer Specific Survival (LCSS)	5 years	5 years

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
Number of actual enrolled patients updated to 9 , in addition attached as per annual process the documents related to SAE , SUSARS and PD	13/12/2019

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Trial details

Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Current status: Approved | Date registered: 17/12/2019 | Date last updated: 13/12/2019

Main Information

Secondary Identifying Numbers

Sources of Monetary or Material Support

Secondary Sponsors

Contact for Public/Scientific Queries

Centers/Hospitals Involved in the Study

Ethics Review

Countries of Recruitment

Health Conditions or Problems Studied

Interventions

Primary Outcomes

Key Secondary Outcomes

Trial Results

Changes History

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