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 comparing two treatments for this condition. One treatment is an investigational drug called Adagrasib, also known by its code name MRTX849, which is taken as a film-coated tablet. The other treatment is a medication called Docetaxel, which is given as an infusion into a vein.
The purpose of the study is to evaluate how effective Adagrasib is compared to Docetaxel in patients who have already received treatment for their lung cancer. Participants in the study will be randomly assigned to receive either Adagrasib or Docetaxel. The study will monitor the participants over time to see how their cancer responds to the treatment and to check for any side effects. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.
Throughout the study, researchers will collect information on how long patients live without their cancer getting worse, as well as overall survival rates and how patients feel during the treatment. The study will also look at the safety of the treatments by tracking any adverse events or side effects. This information will help determine the best treatment option for patients with this type of lung cancer.
1joining the study
Upon joining the study, a diagnosis of advanced non-small cell lung cancer with a specific mutation (KRAS G12C) is confirmed.
Eligibility is determined based on previous treatment history and readiness to receive docetaxel.
2randomization
Participants are randomly assigned to receive either the investigational agent MRTX849 or docetaxel.
This process ensures that each participant has an equal chance of receiving either treatment.
3treatment administration
If assigned to MRTX849, the medication is taken orally in the form of film-coated tablets.
If assigned to docetaxel, the medication is administered intravenously as a solution for infusion.
4monitoring and assessments
Regular monitoring is conducted to assess the progression of the disease and the response to treatment.
Assessments include measuring progression-free survival, overall survival, and response rates.
5safety evaluations
Safety is evaluated by monitoring adverse events, laboratory abnormalities, and any discontinuation of treatment due to adverse effects.
Patient-reported outcomes are collected using specific questionnaires to assess symptoms and quality of life.
6crossover option
Participants initially receiving docetaxel may have the option to switch to MRTX849 if disease progression is observed.
Eligibility for crossover is based on specific criteria, including performance status and disease progression.
7completion of study
The study is estimated to conclude by the end of 2024.
Final assessments will be conducted to evaluate the overall outcomes and effectiveness of the treatments.
Who Can Join the Study?
Must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) with a specific change in the KRAS gene called G12C mutation. This means that tests have shown the presence of this type of lung cancer and the specific genetic change.
Must be eligible to receive treatment with a drug called docetaxel. This means the patient can safely take this medication as part of their treatment plan.
For those switching treatments, there must be evidence of disease progression according to specific criteria called RECIST 1.1 after receiving docetaxel. This means the cancer has continued to grow or spread despite treatment.
For those switching treatments, the patient must have an ECOG performance status of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations but still able to care for themselves.
Both male and female patients are eligible to participate.
Participants should not be part of a vulnerable population, meaning they should be able to give informed consent and participate fully in the study.
Who Cannot Join the Study?
Patients who have not been previously treated for their lung cancer.
Patients without the specific genetic change called KRAS G12C mutation in their cancer.
Patients with a type of lung cancer other than Non-Small Cell Lung Cancer.
Patients who are part of a vulnerable population, which means they might need special protection or care.
MRTX849 is an investigational medication being studied for its effectiveness in treating non-small cell lung cancer (NSCLC) in patients who have a specific genetic mutation known as KRAS G12C. This medication is being tested to see if it can help control the cancer in patients who have already received other treatments.
Docetaxel is a chemotherapy drug that is commonly used to treat various types of cancer, including non-small cell lung cancer. It works by interfering with the growth and spread of cancer cells in the body. In this study, docetaxel is being used as a comparison to evaluate the effectiveness of the investigational medication MRTX849.
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 advanced stage, meaning it has spread beyond the lungs to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors, which can interfere with normal lung function and spread to other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course.
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