Clinical Impact and Utility of Digital Health Solutions in Participants Receiving Systemic Treatment in Clinical Practice

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Roche DPM Module
* Drug: Atezolizumab SC
* Other: Local SOC support


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A - Arm 1<br>Participants with metastatic non-small cell lung carcinoma (mNSCLC), extensive-stage small-cell lung carcinoma (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) and who are prescribed an anticancer regimen including intravenous (IV) atezolizumab will use the Roche Digital Patient Monitoring (DPM) Module along with local standard of care (SOC) support. | Device: Roche DPM Module<br>* Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support<br>Other: Local SOC support<br>* Participants will receive local SOC support<br>|
| Experimental: Cohort A - Arm 2<br>Participants with mNSCLC, ES-SCLC, and HCC who are prescribed an anticancer regimen including IV atezolizumab will receive local SOC support. | Other: Local SOC support<br>* Participants will receive local SOC support<br>|
| Experimental: Cohort B<br>Participants with resected Stage IIB-IIIB NSCLC will use the Roche DPM Module along with subcutaneous (SC) atezolizumab in both the hospital and flexcare (home) setting. | Device: Roche DPM Module<br>* Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support<br>Drug: Atezolizumab SC<br>* Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in change of Week 12 value from baseline of participant-reported Total Symptom Interference Score from the MD Anderson Symptom Inventory (MDASI) Core Items (Cohort A) |  | Baseline, Week 12 | 
| Percentage of participants with Flexcare adoption at Cycle 6 (Cohort B) |  | Cycle 6 (cycle length = 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalizations due to serious adverse events (SAEs) (Cohort A) |  | Up to approximately 28 months | 
| Number of cumulative days hospitalized due to SAEs (Cohort A) |  | Up to approximately 28 months | 
| Number of unscheduled visits to the emergency room (ER) or clinic for symptom management (Cohort A) |  | Up to approximately 28 months | 
| 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 (Cohort A) |  | Up to approximately 28 months | 
| Change from baseline in EuroQol EQ-5D-5L index-based instrument (Cohort A) |  | Up to approximately 28 months | 
| Change from baseline in EuroQol EQ-5D-5L Visual Analogue Scale (VAS) instrument (Cohort A) |  | Up to approximately 28 months | 
| Change from baseline in mean symptom severity score from the MDASI Core Items (Cohort A) |  | Up to approximately 28 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health