Study of efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected non-small cell lung cancer
- Conditions
- stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) 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
- EUCTR2017-004011-39-PT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1382
Subjects eligible for inclusion in this study have to meet all of the following criteria at the time of screening:
1.Written informed consent must be obtained prior to any screening procedures.
2.Age = 18 years
3a.Completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only). The maximum number of days allowed from surgery to randomization is:
-70 days if subjects were treated with surgery, but did not receive chemotherapy or radiation.
-182 days if subjects were treated with surgery and chemotherapy, but no radiation.
-259 days if subjects were treated with surgery, chemotherapy and radiation.
7a.Subjects must have recovered from all toxicities related to prior systemic therapy to grade = 1 (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia, neuropathy (grade =2), and subjects meeting the laboratory specifications described in inclusion 8.
8.Subjects must have adequate organ function including the following laboratory values at the screening visit:
•Absolute neutrophil count (ANC) = 1.5 x 109/L
•Platelets = 100 x 109/L
•Hemoglobin (Hgb) > 9 g/dL
•Creatinine clearance greater than 45 ml/min using Cockcroft-Gault formula
•Total bilirubin = 1.5 x ULN
•Aspartate transaminase (AST) = 3 x ULN
•Alanine transaminase (ALT) = 3 x ULN
9.ECOG performance status (PS) of 0 or 1.
10.Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Inclusion criteria applicable for sub-study (CACZ885T2301A):
1. Written informed consent to sub-study must be obtained prior to any collections.
2. Age = 18 years.
3. Subjects with NSCLC Stage IIA-IIIA, IIIB (N2 disease only) who are candidates for complete resection surgery.
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 825
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 675
Subjects eligible for this study must not meet any of the following criteria at the time of screening:
1.Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery.
2.Subjects who received neoadjuvant chemotherapy or neoadjuvant radiotherapy.
3a.Presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years.
4a.History of clinically significant interstitial lung disease (= grade 2).
5a.History or current diagnosis of cardiac disease, including any of the following:
•recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months,
•uncontrolled congestive heart failure,
•unstable angina (within last 6 months),
•clinically significant (symptomatic) cardiac arrhythmias.
6a.Thoracic radiotherapy to lung fields = 4 weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities.
7.Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to randomization or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and subjects can be enrolled in the study =1 week after the procedure.
8.Uncontrolled diabetes as defined by the investigator.
9.Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results).
10a.Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible. In subjects without active tuberculosis, if the results of the evaluation require treatment per local guidelines, then the treatment should be initiated before randomization (unless otherwise required by Health Authorities or IRB in which case curative treatment must be completed prior to screening).
11a.Subjects with suspected or proven immunocompromised state or infections, including:
a.Known history of testing positive for Human Immunodeficiency Virus (HIV) infections.
b.Those with any other medical condition such as active infection, treated or untreated, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy.
c.Allogeneic bone marrow or solid organ transplant.
d.Those requiring systemic or local treatment with any immune modulating agent in doses with systemic effects e.g.:
i.Prednisone >20mg (or equivalent) oral or intravenous daily for >14 days;
ii.Prednisone > 5mg and = 20mg (or equivalent) daily for > 30 days;
iii.Equivalent dose of methrotexate > 15mg weekly.
12a. Live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
13.Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1ß inhibitor).
14.History of hypersensitivity to canakinumab or drugs of a similar class.
15.Subjects who have received any investigational drug or device within 30 days prior to first dose of study drug or those who are expected to participate in any other investigational drug or device during the conduct of the study.
16.Subjects receiving any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatace
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