Cohort A: ?Metastatic non-small cell lung carcinoma (mNSCLC) ?Extensive-stage small-cell lung carcinoma (ES-SCLC) ?Advanced or unresectable hepatocellular carcinoma (HCC) Cohort B: Resected Stage IIB, IIIA, IIIB(T3-N2) non-small cell lung carcinoma (NSCLC) MedDRA version: 20.0 Level: LLT Classification code 10025064 Term: Lung carcinoma System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10036706 Term: Primary liver cancer non-resectable System Organ Class: 100
Conditions
Interventions
Product Name: ATEZOLIZUMAB SC
Product Code: RO5541267
Pharmaceutical Form: Solution for injection in vial
INN or Proposed INN: Atezolizumab
CAS Number: 1380723-44-3
Current Sponsor code: RO5541267
Oth
Sponsors
F. Hoffmann La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All Participants ?Participant is aged >= 18 years ?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 ? Participant is systemic therapy naïve ? Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2 ? Life expectancy >= 12 weeks Cohort B Participants must confirm adequacy of their home to conduct trial related procedures at home ? Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) non-small cell lung carcinoma (NSCLC) ? 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 IVDR approved test should be used for local testing of PD-L1. ? Participants must 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 human immunodeficiency virus (HIV) test at screening, with the following exception: participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an undetectable viral load ? Negative hepatitis B surface antigen (HBsAg) test at screening ? Negative hepatitis B surface antibody (HBsAb) or positive HBsAb test at screening ? Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening ? For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: All Participants ?Participants with any physical or cognitive condition that, according to clinical judgment, 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 ?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 ?Participants not receiving atezolizumab, but an atezolizumab biosimilar or noncomparable biologic ?Participants currently using another DPM, or electronic participant reported outcome (ePRO) solution for symptom management and/or reporting 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 ? 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 (e.g., 5-year OS rate > 90%), 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 ?Uncontrolled tumor-related pain ?Uncontrolled or symptomatic hypercalcemia ?Active or history of autoimmune disease or immune deficiency ?History of idiopathic pulmonary fibrosis, organizing pneumonia druginduced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan ?Active tuberculosis ?Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina ?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 ?Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment ?Prior allogeneic stem cell or solid organ transplantation ?Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications ?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 hepatitis B virus (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- cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), anti– programmed cell death protein 1 (PD-1), and anti– programmed cell death-ligand 1 (PD-L1) therapeutic antibodies ?Treatment with sy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cohort A To demonstrate superiority of the Roche digital patient monitoring (DPM) atezolizumab Module on symptom interference, when used on top of SOC Cohort B To evaluate the feasibility of combining the Roche DPM atezolizumab subcutaneous (SC) Module and atezolizumab SC administered at the patient's home;Secondary Objective: Cohort A To assess the impact of the Roche DPM atezolizumab Module on number of hospitalizations and number of cumulative days hospitalized due to SAEs, unscheduled visits to the ER or clinic visits for symptom management, incidence, nature, and severity of all anti-cancer treatment associated AEs with additional analyses on Grade >= 3 AEs, SAEs, selected immune-related adverse events, WTS, interruption, modification, or discontinuation of atezolizumab regimen due to AEs, change from baseline in Global Health Status score/Quality of Life score (GHS/QoL) from the EORTC IL6 GHS/QoL, in EuroQol EQ-5D-5L index-based and VAS instrument and in the mean symptom severity score from the MDASI Core Items To assess the safety of the Roche DPM atezolizumab Module compared with local standard of care (SOC) support ;Primary end point(s): Cohort A 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 Cohort B 2.At home treatment adoption at Cycle 6;Timepoint(s) of evaluation of this end point: 1.Cohort A: From baseline (Cycle 1, Day 1) to Week 12 2.Cohort B: At Cycle 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Cohort A and B 1-3.Up to 90 days after the participant receives the last dose of atezolizumab (IV) treatment or discontinues atezolizumab treatment (follow up telephone call). 4-6.From baseline (Cycle 1, Day 1), Weeks 6, 12, 18, 24 and follow-up telephone call (90 days) 7-9.Up to 90 days after the participant receives the last dose of atezolizumab (IV) treatment or discontinues atezolizumab treatment (follow up telephone call).;Secondary end point(s): Cohort A 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 Cohort B 8. Number of hospitalizations within one day of atezolizumab SC administration due to SAEs 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 E.5.2.1 | — |
Countries
Australia, Austria, Estonia, Finland, Germany, Italy, Lebanon, Norway, Oman, Spain, Switzerland
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann La Roche Ltd.
Outcome results
None listed