EUCTR2017-004011-39-RO进行中（未招募）1 期
A phase III, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects eligible for inclusion in this study have to meet all of the
- •following criteria at the time of screening:
- •1.1.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
- •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
- •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
排除标准
- •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
- •4a. History of clinically significant interstitial lung disease (= grade 2).
- •5a. History or current diagnosis of cardiac disease, including any of the
- •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
- •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 >20 mg (or equivalent) oral or intravenous daily for >14
- •ii. Prednisone > 5 mg and = 20 mg (or equivalent) daily for > 30 days;
- •iii. Equivalent dose of methotrexate >15 mg 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
- •15. Subjects who have received an investigational drug or device within
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研究者
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