Study of the effect of canakinumab or pembrolizumab given alone or in combination as a pre-surgery therapy for subjects with initial stages of non-small cell lung cancer
- Conditions
- stages AJCC v.8 IB-IIIA non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004813-42-GR
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 110
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 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.
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
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.
4.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.
5. Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method