EUCTR2021-001415-90-AT进行中（未招募）1 期
INTERVENTIONAL PLATFORM STUDYINVESTIGATING THE IMPACT OF DIGITAL HEALTHSOLUTIONS ON HEALTH OUTCOMES ANDHEALTH-CARE RESOURCE UTILIZATION INPARTICIPANTS RECEIVING SYSTEMICTREATMENT IN CLINICAL PRACTICE (ORIGAMA) - ORIGAMA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- 性别
- All
入选标准
- •All Participants
- •?Participant is aged >= 18 years
- •?Participant has an email address, access to an internet-capable device,
- •and access to an internet connection
- •?Participants must have a histologically confirmed diagnosis via local
- •? Participant is systemic therapy naïve
- •? Eastern cooperative oncology group (ECOG) performance status of 0,
- •? Life expectancy >= 12 weeks
- •Participants must confirm adequacy of their home to conduct trial
- •related procedures at home
- •? Participants must have a complete resection of a histologically or
- •cytologically confirmed Stage IIB-IIIB (T3-N2) non-small cell lung
- •carcinoma (NSCLC)
- •? Programmed cell death-ligand 1 (PD-L1) positive as documented
- •through local testing performed per manufacturer's recommendations
- •and requirements of a representative tumor tissue specimen. An
- •appropriate CE marked or IVDR approved test should be used for local
- •testing of PD-L1.
- •? 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 treatment
- •? ECOG Performance Status of 0 or 1
- •? Adequate hematologic and end-organ function
- •? For participants receiving therapeutic anticoagulation: stable
- •anticoagulant regimen
- •? Negative human immunodeficiency virus (HIV) test at screening, with
- •the following exception: participants with a positive HIV test at
- •screening are eligible provided they are stable on anti-retroviral therapy,
- •have a CD4 count >= 200/µL, and have an undetectable viral load
- •? Negative hepatitis B surface antigen (HBsAg) test at screening
- •? Negative hepatitis B surface antibody (HBsAb) or positive HBsAb test
- •at screening
- •? Negative hepatitis C virus (HCV) antibody test or positive HCV
- •antibody test followed by a negative HCV ribonucleic acid (RNA) test at
- •? For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •All Participants
- •?Participants with any physical or cognitive condition that, according to
- •clinical judgment, would prevent the participant from using the DHS
- •?Participants not proficient with any of the available DHS language translations or with psychiatric/neurologic disorders or any condition
- •that may impact the participant's ability to use the DPM solution
- •?Participants currently enrolled in another clinical study, unless it is an
- •observational (non-interventional) clinical study or the follow-up period
- •of an interventional study
- •?Concomitant anti-cancer therapy at the time of starting atezolizumab
- •(IV) regimen on the index date which is not part of a locally approved
- •combination therapy with atezolizumab as per summary of product
- •characteristics (SmPC) or local regulatory documents
- •?Participants not receiving atezolizumab, but an atezolizumab biosimilar
- •or noncomparable biologic
- •?Participants currently using another DPM, or electronic participant
- •reported outcome (ePRO) solution for symptom management and/or
- •?Participants known to have a sensitizing mutation in the epidermal
- •growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase
- •(ALK) fusion oncogene
- •? History of malignancy within 5 years prior to initiation of study
- •treatment, with the exception of the cancer under investigation in this
- •study and malignancies with a negligible risk of metastasis or death
- •(e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in
- •situ of the cervix, non-melanoma skin carcinoma, localized prostate
- •cancer, ductal carcinoma in situ, or Stage I uterine cancer
- •?Uncontrolled tumor-related pain
- •?Uncontrolled or symptomatic hypercalcemia
- •?Active or history of autoimmune disease or immune deficiency
- •?History of idiopathic pulmonary fibrosis, organizing pneumonia druginduced
- •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 intravenous (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)
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研究者
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