A phase III, multicenter, randomized, double blind, placebo controlledstudy 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 (T5cmN2) completely resected (R0) non-small cell lung cancer(NSCLC)

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

阶段: 3 期
状态: 招募中
发起方

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

入排标准

入选标准

•1. Written informed consent must be obtained prior to any screening
•procedures.
•2. Age more than 18 years
•3. Completely resected (R0) AJCC/UICC v. 8 stage IIA with T less than 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.
•4. Subjects with completely resected (R0) AJCC/UICC v. 8 stages IIA,
•IIB, IIIA or IIIB (T less than 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 less than or equal to 5 cm only) or stage IIIB (Tless than 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 less than 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(less than 4-5 cm).
•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 less than or equal to 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and grade 2 or lessneuropathy 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) more than or equal to 1.5 x 109/L
•Platelets more than or equal to 100 x 109/L
•Hemoglobin (Hgb) more than 9 g/dL
•Creatinine clearance greater than 45 ml/min using Cockcroft-Gault formula
•Total bilirubin mess than or equal to 1.5 x ULN
•Aspartate transaminase (AST) less than or equal to 3 x ULN
•Alanine transaminase (ALT) less than or equal 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.

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.
•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
•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 Ã¢â?°Â¤ 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 greater than 5cm N2 disease, (mediastinal radiation).
•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 greater than or equal to 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).
•10. Subjects with a history of tuberculosis (TB) infection, active or latent,
•or one of the following risk factors:
•History of any of the following: residence in a
•congregate setting: jail or prison, homeless shelter or
•chronic care facility, substance abuse (injected or noninjected);
•health care workers with unprotected
•exposure to subjects who are at high risk of TB or
•subjects with TB disease before identification and
•correct airborne precautions of the infected subject.
•Close contact (i.e. sharing the same air space in a household or other enclosed environment for
•prolonged period (days or weeks, not hours or
•Novartis Confidential Page 14
•Oncology Protocol (Version No. 00) Protocol No. CACZ885T2301 minutes) with a person with active TB disease within
•the past 12 months. Evidence of TB infection, active or latent, at screening
•as determined by purified protein derivative (PPD)
•skin test and /or QuantiFERONÃ?Â®-TB Gold (QFT-g)
•assay as defined by country guidelines (refer to
•Determination of TB status to be further defined in full
另有 1 项未显示

研究者

发起方

ovartis Healthcare Pvt Ltd

相似试验

进行中（未招募）

1 期

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 cancerstages 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)

EUCTR2017-004011-39-ROovartis Pharma AG1,500

进行中（未招募）

1 期

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 cancerstages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2017-004011-39-FRovartis Pharma AG1,500

进行中（未招募）

1 期

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 cancerstages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2017-004011-39-CZovartis Pharma AG1,500

进行中（未招募）

1 期

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

EUCTR2017-004011-39-PTovartis Pharma AG1,382

进行中（未招募）

1 期

EUCTR2017-004011-39-HUovartis Pharma AG1,500