This study focuses on individuals with Nonsquamous Non-Small Cell Lung Cancer, a type of lung cancer, specifically those at stage IV or advanced stage IIIB/C. The research is for patients whose tumors do not show high levels of PD-L1, a protein used to help the immune system find cancer, and instead have a specific genetic change known as a KRAS p.G12C mutation. The purpose of the study is to compare the effectiveness of two different treatment approaches used as a first-line therapy.
One group will receive sotorasib combined with a platinum doublet, which refers to a combination of two drugs like carboplatin and pemetrexed. The other group will receive pembrolizumab along with the same platinum doublet. Other medications, such as folic acid, hydroxocobalamin, dexamethasone, and antiemetics, may be used to support the treatment and manage side effects. During the study, the time until the cancer grows or worsens and the total length of time patients live are monitored.
Who Can Join the Study?
You must be a man or a woman who is 18 years of age or older.
You must have a confirmed diagnosis of nonsquamous non-small cell lung cancer, which is a specific type of lung cancer that does not start in the mucus-producing cells.
Your cancer must be at Stage IV or advanced Stage IIIB/C, meaning the cancer is at an advanced stage and has spread or is growing significantly.
Tests must show you have a specific genetic change called a KRAS p.G12C mutation, which is a change in the protein that helps cancer cells grow.
Tests must show that your cancer is negative for PD-L1, which means a specific protein used by cancer cells to hide from the immune system is not present in large amounts.
You must not have previously received systemic anticancer therapy, which refers to medicines like chemotherapy that travel through the entire body, to treat cancer that has spread or cannot be cured.
You must have an ECOG score of 1 or less, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
Who Cannot Join the Study?
You cannot participate if your lung cancer is a mixed histology type, which means the cancer cells are a mix of different types, or if it contains small-cell or large-cell neuroendocrine cells (specific types of fast-growing cancer cells), or if it is mostly squamous cell (a specific type of cancer cell found in the lining of organs).
You are excluded if your tumor has molecular alterations, which are specific changes or mutations in the cancer’s DNA, that can already be treated with a targeted therapy (a medicine designed to attack a specific part of a cancer cell) that is approved in your area.
You cannot join if you have brain metastases, which means the cancer has spread to the brain, and it is causing symptoms (physical signs of illness) whether it has been treated or not.
You are excluded if you have gastrointestinal (GI) tract disease, which is any illness affecting your digestive system (such as the stomach or intestines), that makes it impossible for you to swallow or take medicine by mouth.
You cannot participate if you have had a myocardial infarction, commonly known as a heart attack, within the last 6 months, or if you have unstable arrhythmias (irregular heartbeats that are not controlled) or unstable angina (chest pain caused by reduced blood flow to the heart that is changing or worsening).
You are excluded if you have previously received treatment using a KRAS G12C inhibitor, which is a specific type of drug designed to block a particular mutation in the cancer.
Sotorasib is the main experimental treatment being tested in this study. It is a pill taken by mouth and is being studied to see how well it works when combined with chemotherapy to treat certain types of advanced lung cancer.
Pembrolizumab is a medication used as a comparison in this study. It is given through an IV (into a vein) and is part of a treatment plan used to compare against the experimental therapy to see which is more effective for patients with this specific type of lung cancer.
Non-small cell lung cancer – This is a type of lung cancer that starts in the cells lining the inside of the lungs. It is the most common form of lung cancer and can involve different types of cells. The disease progresses as abnormal cells grow and multiply uncontrollably within the lung tissue. Over time, these cells may spread to nearby tissues or other parts of the body. In advanced stages, the cancer can involve several regions or distant organs.
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