BridgeMD
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)
EU CTIS ID: 2023-504342-55-00
What this study is testing
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
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Malaysia
- Australia
- Switzerland
- Oman
- Lebanon
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malaysia; Australia; Switzerland; Oman; Lebanon. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.