INTERVENTIONAL PLATFORM STUDY INVESTIGATING THE IMPACT OF DIGITAL HEALTH SOLUTIONS ON HEALTH OUTCOMES AND HEALTH-CARE RESOURCE UTILIZATION IN PARTICIPANTS RECEIVING SYSTEMIC TREATMENT IN CLINICAL PRACTICE (ORIGAMA) - MO42720

F. Hoffmann-La Roche AG0 个研究点目标入组 235 人开始时间: 2023年12月12日最近更新: 2024年7月22日

适应症

试验速览

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•Participant has an email address, access to an internet-capable device, and access to an internet connection, Cohort A Participants must have a histologically confirmed diagnosis via local labs, Cohort A Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2 Cohort B ECOG Performance Status of 0 or 1, Cohort A Life expectancy >= 12 weeks, Cohort B Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) non-small cell lung carcinoma (NSCLC), Cohort B 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 In-Vitro Diagnostics Device approved test should be used for local testing of PD-L1.

•Participants with any physical or cognitive condition that, according to clinical judgment, would prevent the participant from using the Digital Health Solution (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 DHS, 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, Cohort A 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, Cohort B Participants known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene, Cohort B 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, 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

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