Study on Atezolizumab for Patients with Lung and Liver Cancer Using Digital Health Solutions

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called atezolizumab, which is a solution for injection, on various types of cancer. The study involves two groups of participants. The first group includes individuals with advanced forms of lung cancer, specifically metastatic non-small cell lung carcinoma and extensive-stage small-cell lung carcinoma, as well as those with advanced or unresectable hepatocellular carcinoma, a type of liver cancer. The second group consists of individuals who have had surgery for early-stage non-small cell lung cancer.

The purpose of the study is to explore how digital health solutions can impact health outcomes and the use of healthcare resources for people receiving systemic treatment, which is a type of treatment that affects the entire body. In the first group, the study aims to show how a digital patient monitoring system can help manage symptoms for those receiving atezolizumab. In the second group, the study will look at how feasible it is to combine this digital monitoring with atezolizumab treatment administered at home.

Participants in the study will receive either atezolizumab or a placebo. The study will monitor various aspects of health, including symptom management and the number of hospital visits. The trial will also assess the safety and side effects of atezolizumab when used in combination with digital health tools. The study is expected to continue until 2025, with participants being observed over a period of time to gather comprehensive data on the treatment’s effectiveness and impact on quality of life.

1 joining the study

Upon joining the study, the participant will be assigned to one of two groups, known as Cohort A or Cohort B, based on their specific medical condition.

Cohort A includes individuals with metastatic non-small cell lung carcinoma, extensive-stage small-cell lung carcinoma, or advanced hepatocellular carcinoma.

Cohort B includes individuals with resected Stage IIB-IIIB non-small cell lung carcinoma.

2 treatment administration

Participants will receive a medication called atezolizumab, which is administered as a solution for injection under the skin (subcutaneous).

The treatment will be conducted in a home setting, utilizing digital health solutions to monitor health outcomes and resource utilization.

3 monitoring and assessment

The study will evaluate the impact of digital health solutions on symptom management and overall health outcomes.

Participants will report their symptoms using a tool called the MD Anderson Symptom Inventory, which helps track changes in symptom interference over time.

4 evaluation of treatment effects

The primary goal is to assess the change in symptom interference after 12 weeks of treatment.

Secondary evaluations include monitoring hospitalizations, emergency visits, and any adverse effects related to the treatment.

5 completion of study

The study is expected to conclude by August 2025.

Participants will continue to be monitored for any long-term effects or changes in their health status.

Who Can Join the Study?

Participant must have an email address, access to a device that can connect to the internet, and an internet connection.
For Cohort A, participants must have a confirmed diagnosis of their condition through local laboratory tests.
For Cohort A, participants should have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how a disease affects a patient’s daily living abilities.
For Cohort B, participants should have an ECOG performance status of 0 or 1.
For Cohort A, participants should have a life expectancy of at least 12 weeks.
For Cohort B, participants must have had a complete surgical removal of a confirmed Stage IIB-IIIB non-small cell lung carcinoma (NSCLC).
For Cohort B, participants must be PD-L1 positive, which means their tumor shows a specific protein that can be identified through a test.

Who Cannot Join the Study?

Patients who have a different type of cancer than those specified in the study.
Patients who are not in the age range specified for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have a medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are planning to have surgery during the study.
Patients who have an active infection that requires treatment.
Patients who have a history of severe allergic reactions to the study medication or similar drugs.
Patients who have a mental health condition that might interfere with their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Universitario De Jaen	Jaen	Spain
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Onkologie Rheinsieg Praxisnetzwerk	Troisdorf	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Son Llatzer	Palma	Spain
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg	Aschaffenburg	Germany
Ktxceb Drj Hccuteo Gwzo	Stade	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	20.02.2023
Germany	Not recruiting	20.02.2023
Spain	Not recruiting	20.02.2023

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body’s immune system fight cancer. Atezolizumab works by blocking a protein that prevents the immune system from attacking cancer cells. In this study, it is being evaluated for its effectiveness when administered subcutaneously, which means it is given as an injection under the skin. The trial aims to see how well this method works when patients receive the treatment at home.

Roche Digital Patient Monitoring (DPM) Atezolizumab Module is a digital health solution used in the trial. This module is designed to monitor patients’ symptoms and how they interfere with daily life. It helps healthcare providers track the patient’s condition remotely and make informed decisions about their treatment. The study is investigating whether this digital tool can improve health outcomes for patients receiving atezolizumab.

Metastatic Non-Small Cell Lung Carcinoma – This is a type of lung cancer that has spread from the lungs to other parts of the body. It begins in the cells lining the lungs and can progress to affect other organs. As the disease advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The spread of cancer cells can lead to complications in various body systems.

Extensive-Stage Small-Cell Lung Carcinoma – This aggressive form of lung cancer is characterized by its rapid growth and spread beyond the lungs. It often affects the lymph nodes and other organs early in its course. Symptoms may include coughing, chest pain, and shortness of breath. The disease can progress quickly, leading to significant health challenges.

Advanced or Unresectable Hepatocellular Carcinoma – This is a primary liver cancer that cannot be removed surgically due to its advanced stage or location. It originates in the liver cells and can grow to affect liver function and spread to other parts of the body. Symptoms may include abdominal pain, weight loss, and jaundice. The progression of the disease can lead to liver failure and other complications.

Resected Stage IIB-IIIB Non-Small Cell Lung Carcinoma – This refers to early-stage lung cancer that has been surgically removed but was initially classified as stage IIB to IIIB. It involves cancer that has spread to nearby tissues or lymph nodes but not to distant parts of the body. After resection, monitoring is crucial to detect any recurrence. The disease’s progression is typically slower compared to more advanced stages.

Trial ID:

2023-504342-55-00

Protocol code:

MO42720

Trial Phase:

Therapeutic use (Phase IV)

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Study on Atezolizumab for Patients with Lung and Liver Cancer Using Digital Health Solutions

What is this study about?

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