BRIDGE trial: Phase II trial of durvalumaB and chemotheRapy Induction followed by Durvalumab and radiotherapy in larGe volumE stage III NSCLC - BRIDGE

IRCCS - ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 65 人开始时间: 2021年4月21日最近更新: 2022年1月24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: 65

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

•(1) provision of signed, written and dated informed consent, (2) male or female aged 18 years or older, (3) histologically- or cytologically-documented locally advanced NSCLC (Stage III-v.8 IASLC), (4) patient eligible for platinum-based chemotherapy (platinum – pemetrexed for non-squamous and platinum- vinorelbine for squamous histology), (5) patient not eligible for surgery and chemoradiation (each patient will be discussed in a web multidisciplinary team among all the three involved Cancer Core Europe [CCE] centers) (6) tumor sample requirements: availability of an archived tumor tissue block (or unstained slides to perform local PDL1 assessment following protocol procedure), (7) patient’s willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives test for female pre-menopausal patients, (8) life expectancy =12 weeks at the start of treatment, (9) ECOG Performance Status of 0 – 1, (10) Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients, (11) patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up, (12) adequate organ and marrow function, (13) absence of a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to durvalumab and/or to any of their excipients.
•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 33
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

排除标准

•(1) stage IV NSCLC, (2) patient amenable to curative intent surgery or concurrent
•chemoradiation, (3) mixed small cell and non-small cell lung cancer histology, (4)
•patients who already received therapy for locally advanced NSCLC, (5) dyspnea of minimal exertion or oxygen requirement, (6) recent medical history of cardiac events during the last 6 months (ischemic or congestive heart failure), (7) pancoast tumors, (8) previous radiotherapy to the thorax (prior to inclusion), including radiotherapy for breast cancer, (9) prior exposure to any anti-PD-1 or anti-PD-L1 antibody, (10) participation in another clinical study with an investigational product during the last 4 weeks (11) any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer
•treatment, (12) active or prior documented autoimmune disease within the past 2 years or inflammatory disorders, (13) uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, ongoing or active infection, including any patient known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis, psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent, (14) history of another primary malignancy except for: malignancy treated with curative intent and with no known active disease =3 years before the first
•dose of study drug and of low potential risk for recurrencem, adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease, superficial bladder cancer without evidence of disease, adequately treated carcinoma in situ without evidence of disease, eg, cervical cancer in situ, (15) female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control, (16) any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.

研究者

发起方

IRCCS - ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

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