A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLEDSTUDY EVALUATING THE EFFICACY AND SAFETY OFCANAKINUMAB VERSUS PLACEBO AS ADJUVANT THERAPY IN ADULTSUBJECTS WITH STAGES AJCC/UICC V. 8 II-IIIA AND IIIB (T>5CM N2) COMPLETELY RESECTED (R0) NON-SMALL CELL LUNG CANCER (NSCLC)

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 5 人开始时间: 2019年1月2日最近更新: 2023年11月13日

试验速览

暂无简介。

•1. Age ≥ 18 years
•2. Completely resected (R0) AJCC/UICC v. 8 stage IIA with T>4-5 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.
•3. 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.
•4. 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.
•5. 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).
•Adjuvant chemotherapy is mandatory (at least 2 cycles) for all subjects except those who have stage IIA disease with T>4-5 cm.
•Chemotherapy must be cisplatin based. Combination partners may include vinorelbine, etoposide, docetaxel or gemcitabine for any histology. For nonsquamous carcinomas only, the combination partner may be pemetrexed.

•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.
•3. 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.
•4. History of interstitial lung disease.
•5. 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).
•6. 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, (mediastinal radiation).

发起方

OVARTIS BIOSCIENSES PERU S.A.,