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.
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.
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There are 27 Locations for this study
La Jolla California, 92037, United States
Kansas City Kansas, 66160, United States
Syracuse New York, 13210, United States
Houston Texas, 77030, United States
Bruxelles , 1000, Belgium
Montreal Quebec, H2W 1, Canada
Montpellier cedex 5 Herault, 34059, France
Bron , 69677, France
Paris , 75679, France
Bad Berka , 99437, Germany
Giessen , 35392, Germany
Halle (Saale) , 06120, Germany
Koeln , 51109, Germany
Thessaloniki , 57001, Greece
Kashiwa Chiba, 277 8, Japan
Breda , 4819 , Netherlands
Hertogenbosch , 5200, Netherlands
Maastricht , 6229 , Netherlands
Omsk , 64401, Russian Federation
Saint Petersburg , 19702, Russian Federation
St Petersburg , 19527, Russian Federation
Jaen Andalucia, 23007, Spain
Oviedo Asturias, 33011, Spain
Madrid , 28034, Spain
Taipei , 110, Taiwan
Taipei , , Taiwan
Izmir , , Turkey
Sakarya , 54290, Turkey
Sihhiye / Ankara , 06100, Turkey
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