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.

  • Interventional
  • Recruiting
  • NCT03968419
Eligibility Details Visit Clinicaltrials.gov

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)

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03968419

IRB#IRB19-1679

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianEverett E. Vokes

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting