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) (CANOPY-A)

Novartis Pharma. K.K.1 个研究点目标入组 1,500 人开始时间: 待定最近更新: 2024年2月27日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 1,500
试验地点: 1
主要终点: Disease free survival (DFS) by local investigator

研究概览研究设计入排标准结局指标研究者研究点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
干预模型: Multi center, randomized, double-blinded, placebo-controlled
主要目的: Treatment Purpose

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Have completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR have NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and are candidates for complete resection surgery
•Cisplatin-based chemotherapy is mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy can be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy is mandatory, after which additional therapies can be given based upon local clinical practice and/or guidelines. Typically, chemotherapy is initiated within 60 days of surgery.
•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
•Have ECOG performance status (PS) of 0 or 1

排除标准

•Have unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
•Have received any neoadjuvant therapy
•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, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer > 3 years.
•Have a history of current diagnosis of cardiac disease
•Have uncontrolled diabetes
•Have known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
•Subjects must be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis are not eligible.
•Have suspected or proven immunocompromised state as described in the protocol
•Had Live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).

结局指标

主要结局

Disease free survival (DFS) by local investigator

DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause.

次要结局

未报告次要终点

研究者

发起方

Novartis Pharma. K.K.

研究点 (1)

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