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Study terminated by sponsor.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Arm 1 | Experimental | 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. |
|
| Cohort A - Arm 2 | Experimental | Participants with mNSCLC, ES-SCLC, and HCC who are prescribed an anticancer regimen including IV atezolizumab will receive local SOC support. |
|
| Cohort B | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roche DPM Module | Device | Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support |
|
| 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 | The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The European Organisation for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The EORTC item library 6 (IL6) GHS/QoL consists of only the GHS and QoL items from the EORTC QLQ-C30. The raw score is calculated as the value of both answers, scored on a 7-point scale that ranges from 1 ("very poor") to 7 ("excellent"), then a linear transformation is applied to produce a score between 0-100. Higher scores indicate a higher QoL. |
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Inclusion Criteria: All Participants
Inclusion Criteria: Cohort A
Inclusion Criteria: Cohort B
Exclusion Criteria: All Participants
Exclusion Criteria: Cohort A
Exclusion Criteria: Cohort B
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-LaRoche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concord Repatriation General Hospital | Sydney | New South Wales | 2139 | Australia | ||
| Sunshine Coast University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37076159 | Derived | Iivanainen S, Baird AM, Balas B, Bustillos A, Castro Sanchez AY, Eicher M, Golding S, Mueller-Ohldach M, Reig M, Welslau M, Ammann J. Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice: protocol for an interventional, open-label, multicountry platform study (ORIGAMA). BMJ Open. 2023 Apr 19;13(4):e063242. doi: 10.1136/bmjopen-2022-063242. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Participants with extensive- stage small-cell lung carcinoma (ES-SCLC) or hepatocellular carcinoma (HCC) or non-small cell lung carcinoma (NSCLC) that are prescribed a locally-approved anti-cancer regimen containing IV atezolizumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab Regimen | Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2023 |
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| Atezolizumab SC | Drug | Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days) |
|
| Local SOC support | Other | Participants will receive local SOC support |
|
| Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days) |
| Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | The EQ-5D-5L is used to calculate a health status utility score for use in health economic analyses. The questionnaire is designed to capture the participant's current health status. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The score range is 0-100, with higher scores indicating better outcomes. | Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days) |
| Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life. | Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days) |
| Number of Cumulative Days Hospitalized Due to SAEs | Up to approximately 16 months |
| Birtinya |
| Queensland |
| 4575 |
| Australia |
| Monash Medical Centre Clayton | Clayton | Victoria | 3168 | Australia |
| Latrobe Regional Hospital | Traralgon | Victoria | 3844 | Australia |
| Lkh-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Klinikum Klagenfurt am Wörtersee | Klagenfurt | 9020 | Austria |
| Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg | Aschaffenburg | 63739 | Germany |
| MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin - | Stade | 21680 | Germany |
| Helios Klinik Wuppertal | Wuppertal | 42283 | Germany |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital ClÃnic i Provincial | Barcelona | 08036 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico | Jaén | 23007 | Spain |
| Hôpital Universitaire de Genève (HUG) | Geneva | 1211 | Switzerland |
| CHUV | Lausanne | 1011 | Switzerland |
| FG001 |
| Atezolizumab Regimen + DPM |
Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab Regimen | Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support. |
| BG001 | Atezolizumab Regimen + DPM | Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | The European Organisation for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. The EORTC item library 6 (IL6) GHS/QoL consists of only the GHS and QoL items from the EORTC QLQ-C30. The raw score is calculated as the value of both answers, scored on a 7-point scale that ranges from 1 ("very poor") to 7 ("excellent"), then a linear transformation is applied to produce a score between 0-100. Higher scores indicate a higher QoL. | The ITT population included all randomized participants. | Posted | Median | Full Range | Units on a scale | Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Instrument | The EQ-5D-5L is used to calculate a health status utility score for use in health economic analyses. The questionnaire is designed to capture the participant's current health status. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a VAS that measures health state. The score range is 0-100, with higher scores indicating better outcomes. | The ITT population consisted of all randomized participants. | Posted | Median | Full Range | Units on a scale | Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Symptom Severity Score From the MDASI Core Items | The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life. | The ITT population consisted of all randomized participants. | Posted | Median | Full Range | Units on a scale | Baseline, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Long Term Follow Up/Week 28 (cycle length = 21 days) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Cumulative Days Hospitalized Due to SAEs | The ITT population consisted of all randomized participants. | Posted | Median | Full Range | Days | Up to approximately 16 months |
|
| ||||||||||||||||||||||||||||||
| Primary | 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 | The MDASI assesses symptom severity and symptom interference with different aspects of a patient's life as rated by the patient. For 6 items (pertaining to patient's general activity, walking, work, mood, relations with other people and enjoyment of life), patients rate how the symptoms interfere with different aspects of their life in the last 7 days. The MDASI items are rated from 0-10, with 0 indicating that the symptom is either not present or does not interfere with the patient's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the patient's life. | The ITT population included all randomized participants. | Posted | Median | Full Range | Units on a scale | Baseline, Week 12 |
|
Up to approximately 16 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab Regimen | Participants with metastatic non-small cell lung carcinoma (mNSCLC) or extensive-stage small-cell lung carcinoma (ES-SCLC) or advanced or unresectable hepatocellular carcinoma (HCC) and who were prescribed an anticancer regimen including intravenous (IV) atezolizumab received local standard of care (SOC) support. | 6 | 25 | 10 | 25 | 18 | 25 |
| EG001 | Atezolizumab Regimen + DPM | Participants with mNSCLC or ES-SCLC or HCC who were prescribed an anticancer regimen including IV atezolizumab used the Roche Digital Patient Monitoring (DPM) Module along with local SOC support. | 2 | 24 | 13 | 24 | 22 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| Jul 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cycle 3 Day 1 |
|
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| Cycle 5 Day 1 |
|
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| Cycle 7 Day 1 |
|
|
| Cycle 9 Day 1 |
|
|
| Long Term Follow Up (Week 28) |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
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|
|
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