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.

JRCT ID: jRCT2080225118

Registered date:10/03/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Non-small Cell Lung Cancer
• Date of first enrollment: 05/11/2019
• Target sample size: 110
• Countries of recruitment: Japan,Asia except Japan,Europe
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : canakinumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :
Generic name etc :
INN of investigational material : pembrolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : pembrolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

Major Pathological Response (MPR) rate based on Central review
This will assess the rate of MPR at the time of surgery in all participants randomized to canakinumab alone and in combination with pembrolizumab arms based on central review.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

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

Exclude 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

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT03968419,JapicCTI-205213