Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice
- Cancer
Not yet recruiting
NCT05694013 MO42720
Trial Summary
This study will evaluate the clinical impact and utility of digital health solutions (DHS) on health outcomes and health-care resource utilization in people receiving systemic anti-cancer treatment (approved or non-approved) in clinical practice.
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
Eligibility Criteria
Inclusion Criteria: All Participants
- Email address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connection
Inclusion Criteria: Cohort A
- Histologically confirmed diagnosis for mNSCLC, ES-SCLC, or HCC (Child Pugh A)
- Systemic therapy naive
- Prescribed an atezolizumab IV regimen
- Easter Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Inclusion Criteria: Cohort B
- Complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) NSCLC
- PD-L1 positive
- 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 for hepatitis B virus (HBV) or hepatitis C virus (HCV)
Exclusion Criteria: All Participants
- Any physical or cognitive condition that 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
- Currently participating in another interventional trial
- 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
Exclusion Criteria: 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
- Participants not receiving atezolizumab, but an atezolizumab biosimilar or non-comparable biologic
- Participants currently using another DPM or ePRO solution for symptom management and/or reporting
Exclusion Criteria: Cohort B
- Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- History of leptomeningeal disease
- Uncontrolled or symptomatic hypercalcemia
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Active tuberculosis
- Significant cardiovascular disease
- 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, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact participant safety
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- Prior allogeneic stem cell or solid organ transplantation
- 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 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-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α [TNF-α] agents) 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
- Pregnancy or breastfeeding
- Known allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20
- Pathology (e.g., lower extremity edema, cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous lymph node dissection, etc.) 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 currently using another DPM or ePRO solution for symptom management and/or reporting
For the latest version of this information please go to www.forpatients.roche.com