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 (ORIGAMA)

Phase 1

Conditions: 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 lungcarcinoma (NSCLC)
MedDRA version: 20.0Level: LLTClassification code 10025064Term: Lung carcinomaSystem Organ Class: 100000004864
MedDRA version: 21.0Level: LLTClassification code 10036706Term: Primary liver cancer non-resectableSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-001415-90-AT

Lead Sponsor: F. Hoffmann La Roche Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 440

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 < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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