This clinical trial is focused on studying the effects of a medication called atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC). Atezolizumab is an antibody that helps the immune system fight cancer cells. The study compares the use of atezolizumab with the best supportive care after patients have received chemotherapy based on another drug called cisplatin. The goal is to see if atezolizumab can help prevent the cancer from coming back after surgery.
Participants in the study will receive atezolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will also involve other chemotherapy medications such as vinorelbine, pemetrexed, docetaxel, and gemcitabine, which are small molecule drugs used to kill cancer cells. The study will last for a period of up to 48 weeks for those receiving atezolizumab, while the chemotherapy medications will be administered for a shorter duration.
The purpose of the study is to evaluate how effective atezolizumab is in keeping the cancer from returning, as well as to assess its safety. The study will monitor participants for any signs of cancer recurrence and overall survival rates. This research aims to provide valuable information on whether atezolizumab can be a beneficial treatment option for patients with NSCLC following surgery and chemotherapy.
1joining the study
Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the effectiveness of the medication atezolizumab compared to standard care after chemotherapy in patients with non-small cell lung cancer.
The patient will be assessed to ensure they meet the eligibility criteria, including a performance status of 0 or 1 and a complete resection of the cancer within the specified timeframe.
2initial treatment phase
The patient will receive a chemotherapy regimen based on cisplatin. This phase is crucial for preparing the body for the subsequent treatment with atezolizumab.
The chemotherapy drugs, including vinorelbine, cisplatin, docetaxel, and gemcitabine hydrochloride, will be administered through intravenous infusion. The specific dosage and frequency will be determined by the healthcare provider.
3atezolizumab treatment phase
Following the chemotherapy, the patient will begin treatment with atezolizumab, which is administered as an intravenous infusion. The standard dosage is 1,200 mg.
This treatment aims to improve disease-free survival by preventing the recurrence of cancer. The duration and frequency of atezolizumab administration will be guided by the healthcare provider.
4monitoring and follow-up
Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular assessments of disease status through imaging and clinical evaluations.
The primary goal is to track disease-free survival, which is the time from the start of the trial to any recurrence of cancer or death from any cause.
5completion of the trial
The trial is expected to conclude by April 2026. At the end of the study, the patient’s overall survival and disease-free survival rates will be evaluated.
The results will contribute to understanding the effectiveness of atezolizumab in treating non-small cell lung cancer after chemotherapy.
Who Can Join the Study?
Must have a diagnosis of Non-Small Cell Lung Cancer (NSCLC).
Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
Must have a confirmed diagnosis of Stage IB to IIIA NSCLC, which refers to specific sizes and spread of the lung tumor.
Must have had complete removal of the lung cancer 4 to 12 weeks before joining the study and must have recovered well from the surgery.
If a procedure called mediastinoscopy was not done before surgery, a specific type of lymph node sampling must have been done during surgery. This involves checking certain lymph nodes in the chest area.
Must be eligible to receive a chemotherapy treatment that includes a drug called cisplatin.
Must have normal blood and organ function, meaning the body is working well enough to handle the treatment.
Both men and women can participate.
Participants must be adults, as the study includes age ranges for adults.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Non-Small Cell Lung Cancer.
Patients who do not have the specific PD-L1 subpopulation marker. This marker is a protein that can be found on the surface of some cancer cells.
Patients who are not in the Stage II-IIIA of Non-Small Cell Lung Cancer. This refers to the size and spread of the cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or are part of a vulnerable population that cannot participate in the study.
Atezolizumab is a medication used in this clinical trial. It is an antibody that helps the immune system to detect and fight cancer cells. In this study, it is being tested for its effectiveness and safety in patients who have had surgery to remove non-small cell lung cancer. The goal is to see if it can help prevent the cancer from coming back after chemotherapy.
Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically grows and spreads more slowly than small cell lung cancer. The disease begins in the tissues of the lungs and can spread to other parts of the body. It is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells in which it starts. 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.
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