This clinical trial is focused on studying a type of lung cancer known as Advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. The study is testing a treatment involving two medications: Adagrasib, which is taken as a tablet, and Pembrolizumab, which is given through an infusion into a vein. The purpose of the study is to evaluate how effective and safe these treatments are for patients with this type of lung cancer.
The study is divided into two phases. In the first phase, some patients will receive Adagrasib alone, while others will receive a combination of Adagrasib and Pembrolizumab. In the second phase, the study will compare the combination of Adagrasib and Pembrolizumab against Pembrolizumab alone. This will help researchers understand which treatment works better for patients with this specific mutation in their lung cancer.
Participants in the study will receive their assigned treatment and will be monitored over time to see how their cancer responds. The study will also look at the safety of the treatments by checking for any side effects. The goal is to find the best treatment option for patients with Advanced Non-Small Cell Lung Cancer with the KRAS G12C mutation.
1joining the study
Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient will be required to provide consent to participate in the study.
2initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes a diagnosis of advanced non-small cell lung cancer with a specific genetic mutation known as KRAS G12C.
3treatment phase 2
In phase 2, the patient will receive adagrasib as a monotherapy or in combination with pembrolizumab. Adagrasib is administered orally in the form of a film-coated tablet. Pembrolizumab is given intravenously as a solution for infusion.
4treatment phase 3
In phase 3, the patient will receive a combination of adagrasib and pembrolizumab, or pembrolizumab alone. The treatment aims to compare the effectiveness of the combination therapy against pembrolizumab alone.
5monitoring and evaluation
Throughout the trial, the patient’s response to the treatment will be monitored. This includes regular assessments to measure the size of the tumor and any changes in the patient’s condition.
6safety and side effects
The safety of the treatment will be evaluated by monitoring any side effects or adverse reactions. The patient will be asked to report any symptoms experienced during the trial.
7completion of the trial
Upon completion of the trial, the patient will undergo a final assessment to evaluate the overall effectiveness of the treatment. The results will contribute to the understanding of the treatment’s impact on advanced non-small cell lung cancer.
Who Can Join the Study?
Patients must have a confirmed diagnosis of unresectable or metastaticNon-Small Cell Lung Cancer (NSCLC). “Unresectable” means the cancer cannot be removed with surgery, and “metastatic” means the cancer has spread to other parts of the body.
The cancer must have a specific genetic change called the KRAS G12C mutation.
For Phase 2, patients can have any level of PD-L1 TPS. PD-L1 TPS is a measure of a protein that can affect how the immune system responds to cancer.
For Phase 3, patients must have a PD-L1 TPS of 50% or higher.
For Phase 3, patients must have cancer that can be measured or evaluated using a standard method called RECIST version 1.1.
For Phase 3, patients must have one of the following conditions regarding the brain:
No evidence of cancer spread to the brain.
Untreated cancer spread to the brain that does not need immediate treatment.
Previously treated cancer spread to the brain that does not need immediate treatment.
Patients must be adults, as the study includes age ranges 3 and 4, which typically refer to adults.
Both male and female patients can participate.
The study does not include vulnerable populations, meaning it is not designed for groups that might need special protection.
Who Cannot Join the Study?
Patients who do not have Advanced Non-Small Cell Lung Cancer cannot participate. This is a type of lung cancer that is more advanced.
Patients without the KRAS G12C mutation are excluded. This is a specific change in the cancer’s genetic material.
Patients who are not candidates for first-line treatment are excluded. First-line treatment is the initial treatment given for a disease.
Patients with a PD-L1 TPS less than 50% are excluded. PD-L1 TPS is a measure of a protein that can affect how the immune system responds to cancer.
Patients with unresectable cancer are included. Unresectable means the cancer cannot be removed with surgery.
Patients with locally advanced or metastatic cancer are included. Locally advanced means the cancer has spread to nearby areas, and metastatic means it has spread to other parts of the body.
Adagrasib is a medication being studied for its potential to treat advanced non-small cell lung cancer (NSCLC) in patients with a specific genetic mutation known as KRAS G12C. It is being tested both on its own and in combination with another medication to see how effective and safe it is for patients who are receiving their first treatment for this type of cancer.
Pembrolizumab is a medication that helps the immune system fight cancer. It is being used in combination with adagrasib in this trial to see if the two medications together can better treat advanced non-small cell lung cancer in patients with the KRAS G12C mutation. The trial aims to determine if this combination is more effective than using pembrolizumab alone.
Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its non-small cell nature, which means the cancer cells are larger than those found in small cell lung cancer. It is considered advanced when it has spread beyond the lungs to other parts of the body. The disease progresses as the cancer cells grow and divide uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs, leading to further complications. The progression can vary significantly among individuals, depending on factors like genetic mutations and overall health.
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