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临床试验/EUCTR2021-004067-28-ES
EUCTR2021-004067-28-ES进行中（未招募）1 期

A RANDOMIZED, MULTICENTER, OPEN-LABEL CROSS-OVER STUDY TO EVALUATE PARTICIPANT AND HEALTHCARE PROFESSIONAL REPORTED PREFERENCE FOR SUBCUTANEOUS ATEZOLIZUMAB COMPAREDWITH INTRAVENOUS ATEZOLIZUMAB FORMULATION IN PARTICIPANTS WITH NONSMALL CELL LUNG CANCER

Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd0 个研究点目标入组 140 人开始时间: 2021年10月19日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
140
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

  • •Age >=18 years at time of signing Informed Consent Form
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the treatment period and for 5 months after the final dose of atezolizumab
  • •Adequate hematologic and end-organ function
  • •For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
  • •Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection
  • •Negative HIV and hepatitis B surface antigen (HBsAg) test at screening
  • •Positive hepatitis B surface antibody (HBsAb) test at screening
  • •Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
  • •If a port for IV delivery is present, acceptance to receive atezolizumab IV, and any other IV medication which may be required, through a peripheral line
  • •Participants with Early-stage NSCLC
  • •Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-IIIB NSCLC
  • •Programmed death-ligand 1 (PD-L1) expression >=1%, as documented through local or central testing of a representative tumor tissue specimen
  • •Participants must have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy therapy
  • •Participants with Stage IV NSCLC
  • •Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
  • •Life expectancy >=18 weeks
  • •PD-L1 expression >=50% as documented through local or central testing of a representative tumor tissue specimen
  • •No prior systemic treatment for Stage IV non-squamous or squamous NSCLC
  • •Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle
  • •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 56
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 84

排除标准

  • •History of malignancy within 5 years prior to initiation of study treatment
  • •Uncontrolled tumor-related pain
  • •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage
  • •Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
  • •History of leptomeningeal disease
  • •Uncontrolled or symptomatic hypercalcemia
  • •Active or history of autoimmune disease or immune deficiency
  • •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • •Active tuberculosis
  • •Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • •Severe infection within 4 weeks prior to initiation of study treatment
  • •Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • •Prior allogeneic stem cell or solid organ transplantation
  • •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
  • •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • •Current treatment with anti-viral therapy for hepatitis B virus (HBV)
  • •Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti– programmed cell death protein 1 (PD-1) and anti–PD-L1 therapeutic antibodies
  • •Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • •Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • •Pregnant or breastfeeding, or intending to become pregnant during study treatment or 5 months after the final dose of study treatment
  • •Known allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20
  • •Pathology that could interfere with any protocol-specified outcome assessment
  • •Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization
  • •Participants with Stage IV NSCLC
  • •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

研究者

发起方
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd

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