stages AJCC v.8 IB-IIIA non-small cell lung cancer (NSCLC) MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed NSCLC stage IB-IIIA (per American Joint Committee on Cancer (AJCC) 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors. 2. Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (from the first dose of study treatment). 3. A mandatory newly obtained tissue biopsy is required for study enrollment. An archival biopsy is also acceptable if obtained up to 6 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. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. Subjects with unresectable or metastatic disease. All subjects should have brain imgaing (either Magnetic Resonance Imaging [MRI] brain or Computed Tomography [CT] brain with contrast) prior to enrollment to exclude brain metastasis. 2. History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction. 3. Presence or history of a malignant disease that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. 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. 4. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the MPR rate (=10% of residual viable tumor cells) at the time of surgery in evaluable subjects treated with canakinumab alone and in combination with pembrolizumab;Secondary Objective: 1. To assess the prevalence and incidence of IG (ADA) of canakinumab and pembrolizumab 2. To assess ORR in randomized subjects treated with canakinumab or pembrolizumab as monotherapy or in combination 3. To assess PK of canakinumab and pembrolizumab as monotherapy and in combination 4. To assess surgical feasibility rate in each treatment arm based on randomized subjects 5. To assess the rate of MPR at the time of surgery in (a)evaluable subjects in pembrolizumab monotherapy arm, (b)evaluable subjects based on local review in each treatment arm, (c)randomized subjects based on both central and local review in each treatment arm and (d)to estimate the difference in MPR and posterior probability of the difference in MPR=10% between canakinumab + pembrolizumab combination and pembrolizumab alone 6. To evaluate safety and tolerability of canakinumab and pembrolizumab as monotherapy or in combination 7. To assess the relationship between key blood or tissue based biomarkers and MPR;Primary end point(s): MPR rate based on central review;Timepoint(s) of evaluation of this end point: The primary efficacy analysis will be performed after all subjects have had surgical resection or have discontinued study treatment earlier due to any reason. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ADA prevalence at baseline and ADA incidence on-treatment 2. Overall response rate based on local investigator assessment per RECIST 1.1 3. Concentrations of canakinumab, pembrolizumab 4. Surgical feasibility rate 5. (a) MPR based on central review (b) MPR based on local review (c) MPR based on both central and local review (d) Difference in MPR rate based on central review 6. Type, frequency and severity of AEs (Common Terminology Criteria for Adverse Events [CTCAE] v5.0), vital signs and laboratory abnormalities 7. MPR based on the levels of biomarkers (PD-L1, CD8, hs-CRP, hs-IL-6) assessed at baseline and on treatment;Timepoint(s) of evaluation of this end point: The secondary endpoint analyses will be performed at the same time as the primary endpoint analysis (after all subjects have had surgical resection or have discontinued study treatment earlier due to any reason). | — |
Countries
Austria, Belgium, Canada, France, Germany, Greece, Hungary, Netherlands, Russian Federation, Spain, Taiwan, Turkey, United States
Contacts
Public ContactInformation&Communication Médicales
Novartis Pharma S.A.S
Outcome results
None listed