This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). The study involves participants who have undergone surgery to remove the cancer and have received chemotherapy afterward. The trial is testing the effectiveness and safety of a combination of two medications, Tiragolumab and Atezolizumab, compared to a combination of a placebo and Atezolizumab. Tiragolumab and Atezolizumab are given as infusions, which means they are administered directly into the bloodstream through a vein.
The purpose of the study is to evaluate how well the combination of Tiragolumab and Atezolizumab works in preventing the return of cancer in patients whose tumors have a specific protein called PD-L1. The study will also look at the safety of these medications and how they affect the quality of life of the participants. Participants will receive the treatment over a period of up to 12 months, and their health will be monitored regularly to assess the effects of the treatment.
Throughout the study, researchers will collect information on how long participants remain free of cancer, any side effects they experience, and their overall survival. The study will also measure the levels of Tiragolumab and Atezolizumab in the blood at different times to understand how the body processes these medications. This trial aims to provide valuable insights into the potential benefits of combining Tiragolumab with Atezolizumab for treating NSCLC.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer (NSCLC) and previous treatment with surgery and chemotherapy.
Participants must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.
2initial assessment
An initial assessment is conducted to evaluate the participant’s health status and recovery from previous treatments.
This includes ensuring no unresolved side effects greater than grade 2 from prior chemotherapy.
3treatment phase
Participants receive either tiragolumab plus atezolizumab or a placebo plus atezolizumab.
Both medications are administered through an intravenous infusion.
The specific dosage and frequency are determined by the study protocol.
4monitoring and follow-up
Regular monitoring is conducted to assess the participant’s response to treatment and any side effects.
This includes measuring disease-free survival and overall survival rates, as well as evaluating health-related quality of life.
5completion of study
The study is estimated to conclude by April 30, 2039.
Participants will have follow-up assessments to determine long-term outcomes and any lasting effects of the treatment.
Who Can Join the Study?
Must have a diagnosis of Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer.
Must have an Eastern Cooperative Oncology Group performance status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
Must have a confirmed diagnosis of Stage IIB, IIIA, or certain types of Stage IIIB NSCLC, which are specific stages of lung cancer.
Must have had a complete resection of NSCLC, meaning the tumor was completely removed with no remaining cancer cells.
Must have had a procedure called mediastinal lymph node systematic sampling, which involves checking certain lymph nodes for cancer, though a more thorough procedure called mediastinal lymph node dissection is preferred.
Must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy, which is a type of cancer treatment given after surgery. This includes drugs like cisplatin or carboplatin, combined with other drugs such as pemetrexed, gemcitabine, docetaxel, vinorelbine, etoposide, or paclitaxel.
Must have recovered well from surgery and chemotherapy, with no severe ongoing side effects.
Both males and females can participate.
Participants should not be from vulnerable populations, meaning they should not be in a situation that makes them more at risk or unable to give informed consent.
Who Cannot Join the Study?
Patients with other types of cancer besides Non-Small Cell Lung Cancer cannot participate.
Patients who have not reached the required age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they need special protection, cannot participate.
Patients who do not meet the specific health conditions required for the study cannot participate.
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Not recruiting
15.05.2024
Belgium
Not recruiting
15.05.2024
France
Not recruiting
15.05.2024
Germany
Not recruiting
15.05.2024
Greece
Not recruiting
15.05.2024
Hungary
Not recruiting
15.05.2024
Ireland
Not recruiting
15.05.2024
Italy
Not recruiting
15.05.2024
Poland
Not recruiting
15.05.2024
Romania
Not recruiting
15.05.2024
Slovakia
Not recruiting
15.05.2024
Spain
Not recruiting
15.05.2024
Trial locations
Tiragolumab is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients with certain types of lung cancer.
Atezolizumab is a medication that helps the immune system attack cancer cells. It is used in this study to see if it can help prevent the return of lung cancer after surgery and chemotherapy.
Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Austria 
Belgium 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Poland 
Romania 
Slovakia 
Spain 
