This clinical trial is focused on studying a type of lung cancer known as Non-small Cell Lung Cancer (NSCLC), specifically in cases where the cancer is locally advanced or has spread to other parts of the body. The study is particularly interested in patients whose cancer has a specific genetic change called the KRAS G12C mutation. The main goal is to see if adding a new drug called Adagrasib to the current standard treatment can provide additional benefits for these patients.
The treatment being tested includes a combination of Adagrasib, Pembrolizumab, and chemotherapy drugs such as Cisplatin, Pemetrexed, and Carboplatin. Pembrolizumab is a type of medication that helps the immune system fight cancer, while chemotherapy uses drugs to kill cancer cells. The study will compare this combination to a similar treatment that includes a placebo instead of Adagrasib. Another medication, Palonosetron, is used to help manage side effects like nausea during the treatment.
Participants in the study will receive these treatments through infusions, which means the medication is given directly into the bloodstream. The study will last for a period of time, and researchers will monitor the participants to see how well the cancer responds to the treatment and how long the patients live. The aim is to determine if the addition of Adagrasib can improve outcomes for patients with this specific type of lung cancer.
1initial visit and consent
Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide your consent to participate.
During this visit, your medical history will be reviewed, and you will undergo a physical examination to ensure you meet the study criteria.
2baseline assessments
You will undergo baseline assessments, which may include imaging tests like a computed tomography (CT) scan or magnetic resonance imaging (MRI) to measure your disease.
These assessments help establish a starting point for your treatment and monitor your progress throughout the study.
3treatment phase
You will be randomly assigned to receive either the study treatment or a placebo. The study treatment includes adagrasib, pembrolizumab, and chemotherapy, while the placebo group receives a placebo with pembrolizumab and chemotherapy.
The medications cisplatin, pemetrexed, palonosetron, pembrolizumab, and carboplatin are administered through an intravenous infusion, which means they are given directly into your vein. Adagrasib is taken orally in tablet form.
The frequency and duration of each medication will be explained to you by the study team, and you will receive regular treatments as part of the study protocol.
4regular follow-up visits
You will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical exams, blood tests, and imaging tests.
The study team will assess your progress and any side effects you may experience. It is important to report any new symptoms or concerns during these visits.
5end of treatment
Once the treatment phase is complete, you will have a final assessment to evaluate the overall impact of the treatment on your condition.
The study team will discuss the results with you and provide guidance on any further steps or follow-up care needed.
Who Can Join the Study?
Must have a confirmed diagnosis of non-squamous NSCLC (a type of lung cancer) through a medical test.
The cancer must be locally advanced (spread to nearby areas) or metastatic (spread to other parts of the body).
Must have a measurable disease that can be seen on a CT or MRI scan, with at least one lesion (abnormal area).
Must not have received any previous systemic anti-cancer treatment for advanced or metastatic disease.
Must not be a candidate for treatments aimed at curing the disease, like chemoradiation or complete surgical removal.
Participants with brain metastases (cancer spread to the brain) can join, including those with untreated brain metastases. These brain metastases must not cause symptoms and should not need immediate treatment. Any untreated brain metastases must be 20 mm or smaller in diameter.
Open to both male and female participants.
Participants must be adults.
Who Cannot Join the Study?
Patients who have already received treatment for their advanced lung cancer cannot participate.
Patients without the specific KRAS G12C mutation in their cancer cannot participate. This is a specific change in the cancer’s genetic material.
Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.
Adagrasib is a medication being studied for its potential to help treat a specific type of lung cancer. This type of cancer has a mutation called KRAS G12C. Adagrasib works by targeting this mutation, which may help stop the cancer cells from growing and spreading. In this trial, researchers are looking to see if adding Adagrasib to the usual treatment can provide extra benefits for patients with this kind of lung cancer.
Pembrolizumab is a type of cancer treatment known as immunotherapy. It helps the body’s immune system recognize and attack cancer cells. Pembrolizumab is already used as a standard treatment for various cancers, including lung cancer. In this trial, it is being used in combination with other treatments to see if it can improve outcomes for patients with a specific lung cancer mutation.
Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells or stop them from growing. It is often part of the standard care for many types of cancer, including lung cancer. In this trial, chemotherapy is used alongside other treatments to see if the combination can be more effective for patients with a specific mutation in their lung cancer.
Locally Advanced or Metastatic Non-small Cell Lung Cancer – This disease is a type of lung cancer that begins in the cells lining the lungs and is characterized by its spread beyond the original site. It is classified as “non-small cell” due to the size and appearance of the cancer cells under a microscope. The disease progresses by invading nearby tissues and can spread to other parts of the body, such as the bones, brain, or liver. As it advances, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression can vary, with some cases remaining stable for a period, while others may spread rapidly. The disease is often diagnosed at an advanced stage due to the subtlety of early symptoms.
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