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)

ovartis Farmacéutica, S.A.0 个研究点目标入组 1,500 人开始时间: 2018年3月2日最近更新: 2018年4月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 1,500

研究概览入排标准研究者记录与标识符相似试验

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.Written informed consent must be obtained prior to any screening procedures.
•2.Age = 18 years
•3.Completely resected (R0) AJCC/UICC v. 8 stage IIA with T>4 to 5 cm and N0 (no nodal involvement), if no adjuvant chemotherapy is given, must be randomized within 70 days post complete surgical resection of their NSCLC.
•4.Subjects with completely resected (R0) AJCC/UICC v. 8 stages IIA, IIB, IIIA or IIIB (T>5 cm N2) disease NSCLC, who received chemotherapy and no radiation therapy must be randomized within 182 days post complete surgical resection of their NSCLC.
•5.Subjects with completely resected (R0) AJCC/UICC v. 8 stage IIIA N2 (T =5 cm only) or stage IIIB (T> 5cm N2) disease who receive radiation therapy along with chemotherapy detailed in inclusion criterion 6, must be randomized within 259 days of complete surgical resection.
•6.Adjuvant chemotherapy is mandatory with stage AJCC/UICC v. 8 stage II-IIIA and stage IIIB (T>5cm N2) disease for 4 cycles (21 or 28 day cycles) as per local/national guidelines (except if not tolerated, in which case at least 2 cycles of adjuvant chemotherapy are required).
•Chemotherapy must be cisplatin based. Combination partners may include vinorelbine, etoposide, docetaxel or gemcitabine for any histology. For non-squamous carcinomas only, the combination partner may be pemetrexed.
•7.Subjects must have recovered from all toxicities related to prior systemic therapy to grade = 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy are allowed to enter the study.
•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.
•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

•Subjects eligible for this study must not meet any of the following criteria at the time of screening:
•- Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery.
•- Subjects who received neoadjuvant chemotherapy or neoadjuvant radiotherapy.
•- 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. 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.
•- History of interstitial lung disease.
•- 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 (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).
•- Thoracic radiotherapy to lung fields = 4 weeks prior to starting cycle 1 day 1 or subjects who have not recovered from radiotherapy-related toxicities. Radiation therapy is suggested, but not required to be given to subjects with completely resected (R0) AJCC/UICC v. 8 stage IIIA or IIIB with T>5cm N2 disease, subjects with N2 disease (mediastinal radiation).
•- 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.
•- Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results).
•- Subjects with a history of tuberculosis (TB) infection, active or latent, or one of the protocol-defined risk factors.
•- Subjects with suspected or proven immunocompromised state as defined in the protocol.
•- Live vaccination within 3 months prior to first dose of study drug.
•- Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1ß inhibitor).
•- History of hypersensitivity to canakinumab or drugs of a similar class.
•- Subjects receiving any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, or tocilizumab).
•- Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
•- Women of child-bearing potential as defined in the protocol.
•Other protocol-defined exclusion criteria may apply.

研究者

发起方

ovartis Farmacéutica, S.A.

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