This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study involves patients who have had their cancer completely removed through surgery and are in stages IB (tumor size 4 cm or larger), II, or IIIA. The treatment being tested is called DURVALUMAB, which is given as an infusion into a vein. DURVALUMAB is an immunotherapy, which means it helps the body’s immune system fight cancer cells. Some patients in the study will receive a placebo, which looks like the treatment but does not contain the active drug.
The purpose of the study is to see if DURVALUMAB can help prevent the cancer from coming back after surgery. The study will last for about a year, during which patients will receive the treatment regularly. The main goal is to measure how long patients remain free of cancer after treatment. The study will also look at other factors, such as overall survival, side effects, and quality of life. Researchers are particularly interested in patients whose cancer cells have a specific protein called PD-L1 at a level of 25% or higher and do not have certain genetic changes known as EGFR or ALK mutations.
Throughout the study, patients will be monitored closely to assess the effects of the treatment and any changes in their health. The study aims to provide valuable information on the effectiveness and safety of DURVALUMAB as an additional therapy for patients with completely resected NSCLC. This research could potentially lead to improved treatment options for individuals with this type of lung cancer.
1joining the study
Upon joining the study, participants will be randomly assigned to receive either the study medication, durvalumab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.
2treatment administration
Participants will receive the assigned treatment through an intravenous infusion. This means the medication will be delivered directly into a vein using a needle.
The treatment will be administered regularly over the course of one year. Specific schedules for the infusions will be provided by the study team.
3monitoring and follow-up
Throughout the study, participants will undergo regular health assessments to monitor their condition and any potential side effects. These assessments may include physical exams, blood tests, and imaging studies.
Participants will be asked to report any changes in their health or any side effects they experience during the study period.
4completion of the study
At the end of the one-year treatment period, participants will have a final evaluation to assess their health status and the effects of the treatment.
Participants may be asked to continue with follow-up visits to monitor their long-term health outcomes.
Who Can Join the Study?
Must have a confirmed diagnosis of non-small cell lung cancer (a type of lung cancer) according to the World Health Organization’s classification.
Must have had surgery to completely remove the lung cancer, and the cancer must be classified as Stage IB (tumor size 4 cm or larger), Stage II, or Stage IIIA after surgery.
Must have had a PET scan (a type of imaging test) of the chest and an MRI or CT scan (types of brain imaging tests) before surgery. If not done before surgery, these tests must be completed before joining the study.
The surgery must have removed all visible cancer, and the edges of the removed tissue must not have any cancer cells.
The surgery can be done using open surgery or VATS (a less invasive surgical technique).
Must have had a specific type of lymph node examination during surgery, following international guidelines.
If pre-surgery imaging showed possible cancer in the chest lymph nodes, further testing with mediastinoscopy or EBUS-TBNA (procedures to examine lymph nodes) is recommended.
If cancer is found in the lymph nodes during these tests, the nodes must be surgically removed.
Surgery must be one of the following types: lobectomy, sleeve resection, bilobectomy, or pneumonectomy. Segmentectomy or wedge resection alone is not allowed.
Must be an adult, as the study includes both male and female participants.
Who Cannot Join the Study?
Patients with a history of other types of cancer, except for non-small cell lung cancer.
Patients who have not had their lung cancer completely removed by surgery.
Patients with lung cancer that is not in stage IB (tumor size 4 cm or larger), stage II, or stage IIIA.
Patients whose lung cancer does not express a protein called PD-L1 at a level of 25% or higher. PD-L1 is a protein that can affect the immune system’s ability to fight cancer.
Patients with mutations in genes called EGFR or ALK. These are specific changes in the cancer cells that can affect how the cancer grows.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
MEDI4736 is a medication used in this clinical trial to help prevent the return of non-small cell lung cancer after it has been surgically removed. It is given to patients through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The goal of using this medication is to improve the chances of staying cancer-free for a longer period. It works by targeting a specific protein called PD-L1, which is found on the surface of some cancer cells. By blocking this protein, MEDI4736 helps the body’s immune system recognize and attack the cancer cells more effectively.
Non-Small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses through stages, starting from localized tumors in the lungs to more advanced stages where cancer cells may invade nearby tissues or spread to distant organs. NSCLC is often associated with genetic mutations and environmental factors, such as smoking. The progression of the disease can vary depending on the subtype and stage at diagnosis. Early stages may not show symptoms, but as the disease advances, symptoms like persistent cough, chest pain, and difficulty breathing may occur.
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