2023-504342-55-00已完成3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- 1. Mean difference in change of Week 12 value from baseline of the participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items
研究概览
简要总结
Cohort A • To demonstrate superiority of the Roche digital patient monitoring (DPM) atezolizumab Module on symptom interference Cohort B • To evaluate the feasibility of combining the Roche DPM Atezolizumab Module and Atezolizumab subcutaneous (SC) administered in the at home treatment setting
研究设计
- 分配方式
- Randomized
- 主要目的
- Platform Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
1. Mean difference in change of Week 12 value from baseline of the participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items
1. Mean difference in change of Week 12 value from baseline of the participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items
2. At-home treatment adoption at Cycle 6
2. At-home treatment adoption at Cycle 6
次要结局
- 1. Number of hospitalizations and number of cumulative days hospitalized due to serious adverse events (SAEs)
- 2. Unscheduled visits to the emergency room (ER) or clinic visits for symptom management
- 3. Incidence, nature, and severity of all anti-cancer treatment associated adverse event (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 with additional analyses on Grade >= 3 AEs, Serious adverse events (SAEs), selected immune-related adverse events, weighted toxicity score (WTS), interruption, modification, or discontinuation of atezolizumab regimen due to AEs
- 4. Change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the European Organisation for Research and Treatment of Cancer (EORTC) item library 6 (IL6) GHS/QoL
- 5. Change from baseline in EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and visual analogue Scale (VAS) instrument
- 6. Change from baseline in the mean symptom severity score from the MDASI Core Items
- 7. Incidence and severity of adverse events assessed as related to device use and adverse device effects
- 8. Incidence, nature, and severity of anti-cancer treatment associated AEs as described in the secondary efficacy objectives
- 9. Incidence, nature, and severity of all Atezolizumab SC associated AEs graded according to the NCI-CTCAE v5.0 with additional analyses on: - Grade ≥ 3 AEs - SAEs
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (13)
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