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

NCT05694013 | Terminated Phase 2 Results

• 1 other identifier: MO42720
• Study Type: interventional
• Target: 49
• Locations: 4 countries
• Sites: 10

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.

Conditions

Cancer

Keywords

Remote Patient Monitoring, Digital Patient Monitoring, Symptom Monitoring, Digital Health

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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

  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

  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

  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

Study Arms (3)

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.

Device: Roche DPM Module; Other: Local 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.

Other: 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.

Device: Roche DPM Module; Drug: Atezolizumab SC

Interventions

Roche DPM Module DEVICE

Participants will be trained in the use of the Roche DPM Module, which they will use alongside local SOC support

Cohort A - Arm 1; Cohort B

Atezolizumab SC DRUG

Participants will receive atezolizumab SC for 16 cycles (cycle length = 21 days)

Cohort B

Local SOC support OTHER

Participants will receive local SOC support

Cohort A - Arm 1; Cohort A - Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Email address, access to an internet-capable device (smartphone, tablet, or PC), and access to an internet connection
• 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
• 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)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (14)

Concord Repatriation General Hospital

Sydney, New South Wales, 2139, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Monash Medical Centre Clayton

Clayton, Victoria, 3168, Australia

Location

Latrobe Regional Hospital

Traralgon, Victoria, 3844, Australia

Location

Lkh-Univ. Klinikum Graz

Graz, 8036, Austria

Location

Klinikum Klagenfurt am Wörtersee

Klagenfurt, 9020, Austria

Location

Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

Location

MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -

Stade, 21680, Germany

Location

Helios Klinik Wuppertal

Wuppertal, 42283, Germany

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clínic i Provincial

Barcelona, 08036, Spain

Location

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

Jaén, 23007, Spain

Location

Hôpital Universitaire de Genève (HUG)

Geneva, 1211, Switzerland

Location

CHUV

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37076159 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-LaRoche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 23, 2023
• Study Start: February 27, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CH (2); DE (3); ES (3); AU (2)