This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)

ClinicalTrials.gov Identifier: NCT03968419

Novartis Reference Number: CACZ885V2201C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.

Condition 
Non-small Cell Lung Cancer
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
110 participants
Start date 
Nov 05, 2019
Completion date 
Jan 31, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
canakinumab
Administered subcutaneously
Drug
pembrolizumab
200mg administered intravenously every 3 weeks

Eligibility Criteria

Key inclusion criteria:

Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors.
Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment).
A mandatory newly obtained tissue biopsy from primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment.

Note: Aspirates will not be accepted.

- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

Key exclusion criteria:

Subjects with unresectable or metastatic disease.
History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening
Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy is permitted
Subject with suspected or proven immunocompromised state or infections

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Mayo Clinic - Arizona
Recruiting
Scottsdale, 85259
Arizona
United States
Highlands Oncology Group
Recruiting
Fayetteville, 72703
Arkansas
United States
University Of California
Recruiting
La Jolla, 92037
California
United States
Baptist MD Anderson Cancer Center
Recruiting
Jacksonville, 32207
Florida
United States
University of Kansas Medical Center Neurology Dept.
Recruiting
Kansas City, 66160
Kansas
United States
SUNY - Upstate Medical University
Recruiting
Syracuse, 13210
New York
United States
Levine Cancer Institute SC 1
Recruiting
Charlotte, 28203
North Carolina
United States
Methodist Hospital / Methodist Cancer Center
Recruiting
Houston, 77030
Texas
United States
University of Wisconsin
Recruiting
Madison, 53792
Wisconsin
United States
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1000
-
Belgium
France
Novartis Investigative Site
Recruiting
Montpellier cedex 5, 34059
Herault
France
Novartis Investigative Site
Recruiting
Paris, 75679
-
France
Germany
Novartis Investigative Site
Recruiting
Bad Berka, 99437
-
Germany
Novartis Investigative Site
Recruiting
Giessen, 35392
-
Germany
Novartis Investigative Site
Recruiting
Halle (Saale), 06120
-
Germany
Novartis Investigative Site
Completed
Koeln, 51109
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 11526
-
Greece
Novartis Investigative Site
Recruiting
Thessaloniki, 57001
-
Greece
Hungary
Novartis Investigative Site
Recruiting
Torokbalint, 2045
Pest
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary
Novartis Investigative Site
Recruiting
Miskolc, 3526
-
Hungary
Japan
Novartis Investigative Site
Recruiting
Kashiwa, 277 8577
Chiba
Japan
Netherlands
Novartis Investigative Site
Recruiting
Hertogenbosch, 5200
-
Netherlands
Novartis Investigative Site
Recruiting
Maastricht, 6229 HX
-
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3508 GA
-
Netherlands
Russian Federation
Novartis Investigative Site
Recruiting
Omsk, 644013
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 195271
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Jaen, 23007
Andalucia
Spain
Novartis Investigative Site
Recruiting
Oviedo, 33006
Asturias
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 110
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei,
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Izmir,
-
Turkey
Novartis Investigative Site
Recruiting
Sakarya, 54290
-
Turkey
Novartis Investigative Site
Recruiting
Sihhiye / Ankara, 06100
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]