Lung Cancer Clinical Trial

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.

Summary

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.

View Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

88

Study ID:

NCT03968419

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 27 Locations for this study

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UCLA Oncology Hematology
La Jolla California, 92037, United States
University of Kansas Medical Center Neurology Dept.
Kansas City Kansas, 66160, United States
SUNY - Upstate Medical University
Syracuse New York, 13210, United States
Methodist Hospital / Methodist Cancer Center
Houston Texas, 77030, United States
Novartis Investigative Site
Bruxelles , 1000, Belgium
Novartis Investigative Site
Montreal Quebec, H2W 1, Canada
Novartis Investigative Site
Montpellier cedex 5 Herault, 34059, France
Novartis Investigative Site
Bron , 69677, France
Novartis Investigative Site
Paris , 75679, France
Novartis Investigative Site
Bad Berka , 99437, Germany
Novartis Investigative Site
Giessen , 35392, Germany
Novartis Investigative Site
Halle (Saale) , 06120, Germany
Novartis Investigative Site
Koeln , 51109, Germany
Novartis Investigative Site
Thessaloniki , 57001, Greece
Novartis Investigative Site
Kashiwa Chiba, 277 8, Japan
Novartis Investigative Site
Breda , 4819 , Netherlands
Novartis Investigative Site
Hertogenbosch , 5200, Netherlands
Novartis Investigative Site
Maastricht , 6229 , Netherlands
Novartis Investigative Site
Omsk , 64401, Russian Federation
Novartis Investigative Site
Saint Petersburg , 19702, Russian Federation
Novartis Investigative Site
St Petersburg , 19527, Russian Federation
Novartis Investigative Site
Jaen Andalucia, 23007, Spain
Novartis Investigative Site
Oviedo Asturias, 33011, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Taipei , 110, Taiwan
Novartis Investigative Site
Taipei , , Taiwan
Novartis Investigative Site
Izmir , , Turkey
Novartis Investigative Site
Sakarya , 54290, Turkey
Novartis Investigative Site
Sihhiye / Ankara , 06100, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

88

Study ID:

NCT03968419

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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