A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum-Based Chemotherapy in Patients With Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC

HMRC Clinical Trials Centre0 个研究点目标入组 53 人开始时间: 2017年10月17日最近更新: 2023年10月9日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 53

研究概览研究设计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
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 o limit（—）
性别: All

入选标准

•Patients must have histologically and/or cytologically confirmed diagnosis of squamous or non-squamous, non-small cell carcinoma of the lung. Patients with poorly differentiated tumours will only be eligible if NSCLC is confirmed by immunohistochemistry markers (TTF1/P63 or P40/CK5). Patients with known sensitizing EGFR mutations or known ALK-fusion are not eligible.
•-Patients must have stage IV disease according to the 8th TNM version staging.
•-Patient must consent to provision of, and investigator(s) must confirm adequacy, of non-cytology tissue and confirm access to and agree to submit within 4 weeks of randomization to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays may be conducted.
•- Where adequate amount and quality of tissue exists but local centre regulations prohibit submission of blocks of tumour tissue, two 2 mm cores of tumour from the block and a predetermined number of slides of representative tumour tissue may be substituted. If this is also not permitted per local centre regulations, we will accept slides only. Any issues with respect tumour tissue submission must be discussed with CCTG prior to local activation of the centre. Failure to submit any tissue samples on request will result in the patient being considered ineligible.
•Where no previously resected or biopsied tumour tissue exists or is found to be of inadequate amount or quality, additional excisional biopsy (fine needle aspirate is not adequate) of the primary or metastatic tumour will be required for the patient to be considered eligible for the study and must be done prior to randomization.
•- Patient must consent to provision of samples of blood in order that the specific correlative marker assays may be conducted.
•- All patients must have measurable disease as defined by RECIST 1.1 .All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).
•The criteria for defining measurable disease are as follows:
•CT scan (with slice thickness of 5 mm) equal to or greater than 10 mm longest diameter
•Physical exam (using calipers) equal to or greater than 10 mm
•Lymph nodes by CT scan equal to or greater than 15 mm measured in short axis
•Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.
•- Patients must be 18 years of age or older.
•- ECOG performance status of 0 or 1.
•- - Absolute neutrophils greater than or equal to 1.5 x 10^9/L
•- Platelets greater than or equal to 100 x 10^9/L
•- Hemoglobin greater than or equal to 90 g/L
•- Bilirubin less than or equal to 1.5 x UNL (upper limit of normal)
•- AST and ALT less than or equal to 2.5 x UNL (if liver metastases are present, less than or equal to 5 x UNL)
•- Creatinine less than 1.25 UNL or Creatinine clearance greater than or equal to 45 mL/min
•- Cytotoxic Chemotherapy: Patients may not have received prior cytotoxic chemotherapy for advanced/metastatic disease.
•- Adjuvant Chemotherapy: Patients may have had prior adjuvant therapy for completely resected disease, providing it has been completed at least 12 months prior to randomization.
•Patients treated with concurrent chemotherapy/radiation regimens for unresectable locally advanced Stage III disease will be eligible providing it has been completed at least 12 months prior to randomization.

排除标准

•- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than or equal to 3 years.
•- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
•- Patients with alopecia.
•- Patients with Grave's disease, vitiligo or psoriasis not requiring systemic
•treatment (within the last 2 years).
•- Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on
•hormone replacement.
•- History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade greater than or equal to 3 infusion reaction.
•- Live attenuated vaccination administered within 30 days prior to randomization
•- History of hypersensitivity to durvalumab or tremelimumab or any excipient. Patients who have received other treatment or other antibodies must not have had intolerabletoxicity or required steroids to manage toxicity.
•- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than or equal to 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome.
•- Patients who have untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if now controlled, should have a LVEF greater than or equal to 45%. (Note: patients with uncomplicated controlled hypertension do not require LVEF measurement in the absence of other significant cardiac history)
•- Concurrent treatment with other investigational drugs or anti-cancer therapy
•- Patients with untreated brain or meningeal metastases are not eligible. Patients with treated CNS disease who have radiologic AND clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
•- Pregnant or Lactating Women: Women of childbearing potential must have a pregnancy test (urine or serum) proven negative within 14 days prior to randomization. If urine test is positive, pregnancy testing may then include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associa

研究者

发起方

HMRC Clinical Trials Centre

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