LBCTR : 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: 06/07/2020

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

Key inclusion and exclusion criteria: Age maximum

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

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

Actual enrollment target size

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

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	Nancy Alam	nancy.alam@usj.edu.lb	+961 (0) 1 421000 ext 2335
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 7600
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
New IL / Adding IRB Approval for Bellvue PA1	26/02/2020
updated recruitment status and number of patients enrolled	13/03/2020

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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: 06/07/2020

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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