This clinical trial is focused on studying treatments for a type of lung cancer known as metastatic non-small cell lung cancer (NSCLC). The study is investigating two medications: Rilvegostomig and Pembrolizumab. Rilvegostomig, also known by its code name AZD2936, is a new treatment being tested, while Pembrolizumab, also known as Keytruda, is an existing treatment used for this type of cancer. Both medications are given as an infusion, which means they are administered directly into the bloodstream through a vein.
The purpose of the study is to compare the effectiveness of Rilvegostomig with Pembrolizumab in treating patients with a specific type of lung cancer that has spread to other parts of the body and shows high levels of a protein called PD-L1. The study will look at how long patients live and how long they live without the cancer getting worse. Participants will receive either Rilvegostomig or Pembrolizumab as their first treatment for this type of lung cancer. The study will monitor patients over time to see how well the treatments work and to check for any side effects.
Throughout the study, researchers will collect information on how the treatments affect overall survival, which is the length of time patients live after starting the treatment, and progression-free survival, which is the time patients live without the cancer worsening. Other aspects being studied include the response rate to the treatments, the duration of the response, and any side effects experienced. The study aims to provide valuable information on the potential benefits and risks of using Rilvegostomig compared to Pembrolizumab for treating this type of lung cancer.
1joining the study
Upon joining the study, you will be randomly assigned to receive either rilvegostomig or pembrolizumab as a treatment for your condition, which is metastatic non-small cell lung cancer with high PD-L1 expression.
2treatment administration
If you are assigned to the rilvegostomig group, you will receive the medication through an intravenous infusion. This means the medication will be given directly into your vein. The specific dosage and frequency will be explained to you by the medical team.
If you are assigned to the pembrolizumab group, you will also receive the medication through an intravenous infusion. The dosage is 25 mg/mL, and the frequency and duration will be provided by the medical team.
3monitoring and assessments
Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests like CT or MRI scans to measure the size of your tumor and assess your response to the treatment.
You will be asked to report any side effects or changes in your health to the study team. This is important for ensuring your safety and the effectiveness of the treatment.
4follow-up visits
You will have scheduled follow-up visits with the study team. During these visits, your overall health, quality of life, and any symptoms will be evaluated.
The study team will also assess your physical functioning and any changes in your condition over time.
5end of treatment
At the end of the treatment period, you will have a final assessment to evaluate the overall impact of the treatment on your health and cancer progression.
The study team will discuss the results with you and provide guidance on the next steps for your care.
Who Can Join the Study?
Participant must be at least 18 years old at the time of signing the informed consent form.
Must have adequate organ and bone marrow function. This means the organs and bone marrow are working well enough to participate in the study.
Minimum body weight of 30 kg (about 66 pounds).
Participants must follow local rules for using birth control during the study.
Female participants who can have children must:
Have a negative pregnancy test at the start and before each treatment.
If sexually active with a male partner who can have children, use at least one highly effective birth control method from the start of the study to 4 months after the last treatment.
Not breastfeed or donate eggs from the start of the study to 4 months after the last treatment.
Male participants who are sexually active with a female partner who can have children must:
Use a condom with spermicide (or without if not available) from the start of the study to 4 months after the last treatment.
Not father a child or donate sperm during the study and for 4 months after the last treatment.
Must be able to give signed informed consent, which means they understand and agree to the study’s requirements and restrictions.
Must agree to optional genetic research by signing a separate consent form.
All races, genders, and ethnic groups can participate in this study.
Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), which is a type of lung cancer.
Must have Stage IV metastatic NSCLC (mNSCLC), meaning the cancer has spread and cannot be cured with treatment.
Must not have certain genetic mutations in the cancer that are known to respond to specific treatments.
Must have a WHO/ECOG performance status of 0 or 1, indicating they are fully active or have some symptoms but do not need to stay in bed.
Must have a minimum life expectancy of 12 weeks.
The cancer must show PD-L1 expression, which is a protein that can affect how the immune system responds to cancer.
Must have at least one tumor that has not been treated with radiation and can be accurately measured using a CT or MRI scan.
Who Cannot Join the Study?
Patients who have a different type of cancer other than lung cancer cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are unable to understand or comply with the study procedures cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients who have a known allergy to the study drugs cannot participate.
Patients who have a serious uncontrolled medical condition that could interfere with the study cannot participate.
Patients who have an active infection requiring treatment cannot participate.
Patients who have received a live vaccine within 30 days prior to the study cannot participate.
Rilvegostomig is a medication being studied for its potential to treat a type of lung cancer called metastatic non-small cell lung cancer. This medication is being tested to see if it can help patients live longer and slow down the progression of their cancer. It is being compared to another treatment to see which one works better for patients with a specific type of lung cancer.
Pembrolizumab is a medication already used to treat various types of cancer, including lung cancer. It works by helping the immune system recognize and attack cancer cells. In this study, pembrolizumab is being used as a comparison to see how well it performs against the new medication, rilvegostomig, in treating patients with a specific type of lung cancer. The goal is to determine which treatment is more effective in helping patients live longer and slowing the progression of their cancer.
Lung Cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung’s ability to provide oxygen to the bloodstream. The disease can spread to other parts of the body through a process called metastasis. Lung cancer is often categorized into two main types: non-small cell lung cancer and small cell lung cancer, each with distinct growth patterns. The progression of lung cancer can vary, with some tumors growing slowly over time, while others may spread quickly.
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