This clinical trial is focused on studying treatments for non-small cell lung cancer, a type of lung cancer that is locally advanced, cannot be surgically removed, or has spread to other parts of the body. The study involves three different treatments: Ociperlimab, an anti-TIGIT antibody, used in combination with Tislelizumab, and a comparison with Pembrolizumab, which is followed by a placebo. The purpose of the study is to compare the overall survival of patients receiving these treatments.
Participants in the study will be randomly assigned to one of two groups. One group will receive Ociperlimab in combination with Tislelizumab, while the other group will receive Pembrolizumab followed by a placebo. The treatments are given as infusions, which means they are administered directly into the bloodstream through a vein. The study will monitor the participants over a period of time to assess the effectiveness of the treatments in improving survival rates.
The trial aims to provide valuable information on how these treatments can help patients with non-small cell lung cancer. By comparing the different treatment options, researchers hope to find the most effective approach for managing this type of cancer. The study will also look at the quality of life of participants and any side effects they may experience during the trial.
1randomization
Upon joining the study, you will be randomly assigned to one of two groups: Arm A or Arm B. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.
2treatment administration – arm a
If assigned to Arm A, you will receive a combination of ociperlimab and tislelizumab. Both medications are administered as an infusion, which means they are given directly into your bloodstream through a vein.
The specific dosage and frequency of these infusions will be determined by the study protocol and your healthcare provider.
3treatment administration – arm b
If assigned to Arm B, you will receive pembrolizumab followed by a placebo. Pembrolizumab is also administered as an infusion.
The placebo is a substance with no active medication, used to compare the effects of pembrolizumab. The dosage and frequency will be specified by the study protocol.
4monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effects of the treatment.
These assessments may include physical exams, blood tests, imaging studies, and questionnaires about your quality of life.
5end of treatment
The treatment phase will continue until the study’s end date or until it is determined that you should stop treatment for any reason, such as side effects or disease progression.
Your healthcare provider will discuss the next steps with you at the end of the treatment phase.
6follow-up
After completing the treatment phase, follow-up visits will be scheduled to monitor your health and gather additional information about the long-term effects of the treatment.
These visits are an important part of the study to ensure your well-being and to collect data for the study’s objectives.
Who Can Join the Study?
Must be able to provide written consent and agree to follow the study requirements and schedule.
Must be at least 18 years old or the legal age of consent in the study location.
Must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced or has come back and cannot be treated with surgery or radiation to cure it.
Must not have had any previous treatment for NSCLC that has spread to other parts of the body.
Must agree to provide a sample of tumor tissue for testing.
The tumor must show a protein called PD-L1 in at least 50% of the cancer cells.
Must have at least one tumor that can be measured according to specific guidelines.
Must have a good level of daily functioning, as measured by a scale called ECOG Performance Status, with a score of 0 or 1.
Must have normal organ function based on specific blood tests, including:
Enough white blood cells, platelets, and hemoglobin without needing a blood transfusion or growth factor support in the last 14 days.
Normal kidney function, measured by serum creatinine levels or a calculation of kidney filtration rate.
Normal levels of bilirubin, a substance made by the liver, unless the patient has a condition called Gilbert’s syndrome.
Normal levels of liver enzymes called AST and ALT, unless there is cancer in the liver.
Women who can have children must use a reliable form of birth control during the study and for at least 120 days after the last dose of the study drug. They must also have a negative pregnancy test before starting the study.
Men who are not sterile must use a reliable form of birth control during the study and for at least 120 days after the last dose of the study drug. A sterile male is someone who has been proven to be unable to father children.
Who Cannot Join the Study?
Patients with other types of cancer besides the specific lung cancer being studied cannot participate.
Patients who have had previous treatments that might interfere with the study drugs are not eligible.
Patients with serious heart conditions or other major health issues that could affect their safety during the trial are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend the required visits are not eligible.
Patients with known allergies to the study drugs or similar medications are excluded.
Patients who are participating in another clinical trial at the same time are not allowed to join this study.
Ociperlimab is an experimental medication being studied for its potential to help the immune system fight cancer. It is an antibody that targets a specific protein called TIGIT, which can suppress the immune response. By blocking this protein, ociperlimab may enhance the body’s ability to attack cancer cells.
Tislelizumab is a medication that helps the immune system recognize and fight cancer cells. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer. Tislelizumab is used in combination with other treatments to improve the immune response against cancer.
Pembrolizumab is a medication that boosts the immune system’s ability to fight cancer. It targets the PD-1 protein on immune cells, helping them to detect and destroy cancer cells more effectively. Pembrolizumab is used in various types of cancer treatments to improve patient outcomes.
Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease is termed “locally advanced” when it has spread to nearby tissues or lymph nodes but not to distant body parts. “Unresectable” means that the cancer cannot be removed completely through surgery. “Metastatic” indicates that the cancer has spread to other parts of the body. The progression of this disease can vary, with some tumors growing slowly and others more rapidly.
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