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

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.

Inclusion Criteria: All ParticipantsEmail address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connectionInclusion Criteria: Cohort AHistologically confirmed diagnosis for mNSCLC, ES-SCLC, or HCC (Child Pugh A)Systemic therapy naivePrescribed an atezolizumab IV regimenEaster Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2Inclusion Criteria: Cohort BComplete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) NSCLCPD-L1 positiveHave completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy treatmentECOG Performance Status of 0 or 1Adequate hematologic and end-organ functionFor participants receiving therapeutic anticoagulation: stable anticoagulant regimenNegative for hepatitis B virus (HBV) or hepatitis C virus (HCV)Exclusion Criteria: All ParticipantsAny physical or cognitive condition that would prevent the participant from using the DHSParticipants 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 solutionCurrently participating in another interventional trialHistory 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 deathExclusion Criteria: Cohort AConcomitant 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 atezolizumabParticipants not receiving atezolizumab, but an atezolizumab biosimilar or non-comparable biologicParticipants currently using another DPM or ePRO solution for symptom management and/or reportingExclusion Criteria: Cohort BParticipants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogeneUncontrolled tumor-related painUncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)History of leptomeningeal diseaseUncontrolled or symptomatic hypercalcemiaActive or history of autoimmune disease or immune deficiencyHistory 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) scanActive tuberculosisSignificant cardiovascular diseaseMajor 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 studySevere 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 safetyTreatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatmentPrior allogeneic stem cell or solid organ transplantationTreatment 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 atezolizumabCurrent treatment with anti-viral therapy for HBVTreatment with investigational therapy within 28 days prior to initiation of study treatmentPrior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodiesTreatment 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 treatmentTreatment 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 treatmentHistory of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteinsKnown hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulationPregnancy or breastfeedingKnown allergy or hypersensitivity to hyaluronidase, bee or vespid venom, or any other ingredient in the formulation of rHuPH20Pathology (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 assessmentSpinal 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 randomizationParticipants currently using another DPM or ePRO solution for symptom management and/or reporting