This clinical trial is focused on studying the treatment of Metastatic Squamous Non-small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study will compare two different treatment combinations. One group will receive a new medication called ivonescimab (also known by its code names AK112 or SMT112) combined with chemotherapy drugs carboplatin and paclitaxel or nab-paclitaxel. The other group will receive a medication called pembrolizumab (also known as Keytruda) combined with the same chemotherapy drugs. The purpose of the study is to compare the overall survival of patients receiving these different treatment combinations.
Participants in the study will be randomly assigned to one of the two treatment groups. The treatments will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of time, with regular monitoring to assess the effects of the treatments. The study will also include a placebo group to help understand the effectiveness of the treatments being tested.
Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on the effectiveness and safety of these treatment combinations for patients with Metastatic Squamous Non-small Cell Lung Cancer. This research could potentially lead to improved treatment options for this type of cancer in the future.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood tests and imaging studies may be performed to assess overall health and the status of the lung cancer.
2randomization
Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment.
3treatment administration
Participants receive treatment through intravenous infusion. The specific medications and their combinations depend on the assigned group.
One group receives ivonescimab combined with carboplatin and paclitaxel or nab-paclitaxel. The other group receives pembrolizumab combined with the same chemotherapy drugs.
The frequency and duration of the treatment cycles are determined by the study protocol and will be explained during the trial.
4monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical exams, blood tests, and imaging studies.
Participants are required to attend scheduled follow-up visits to ensure the safety and effectiveness of the treatment.
5completion of treatment
Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.
Participants may be asked to continue follow-up visits to monitor long-term outcomes and any delayed side effects.
Who Can Join the Study?
Voluntarily sign a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
Have adequate organ function, which means your body organs like blood, kidneys, liver, and blood clotting ability are working well enough. This includes:
Blood: Enough white blood cells, platelets, and hemoglobin.
Kidneys: Good creatinine clearance, which shows how well your kidneys are filtering waste.
Liver: Normal levels of bilirubin and liver enzymes.
Blood clotting: Normal prothrombin time and partial thromboplastin time, which are tests to see how well your blood clots.
Female patients of childbearing age must have a negative pregnancy test before starting the study.
Female patients of childbearing potential must agree to use a highly effective method of birth control during the study and for a certain period after the last dose of medication.
Unsterilized male patients must agree to use an effective method of birth control if they have a female partner of childbearing potential during the study and for a certain period after the last dose of medication.
Be 18 years or older at the time of joining the study.
Have an ECOG performance status score of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Have an expected life expectancy of at least 3 months.
Have metastatic (Stage IV) non-small cell lung cancer (NSCLC), which means the cancer has spread to other parts of the body.
Have a confirmed diagnosis of squamous NSCLC. If the cancer has mixed types, it must include a squamous component.
Have a Tumor Proportion Score (TPS) with PD-L1 expression, which is a test to see how much of the tumor has a certain protein that might respond to treatment.
Have at least one measurable noncerebral lesion, which is a tumor that can be measured and is not in the brain.
No prior systemic treatment for metastatic NSCLC. If you had chemotherapy or chemoradiotherapy before, it must have been completed at least 6 months before the cancer spread.
Who Cannot Join the Study?
Patients who have a different type of cancer than the one being studied.
Patients who have a serious medical condition that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer treatment recently.
Patients who have an infection that is not well controlled.
Patients who have a history of severe allergic reactions to the study drugs.
Patients who are unable to follow the study procedures.
Patients who have participated in another clinical trial recently.
Patients who have a mental health condition that could affect their ability to participate.
Ivonescimab is an investigational medication being studied for its potential to treat metastatic squamous non-small cell lung cancer. In this trial, it is combined with chemotherapy drugs to evaluate its effectiveness in improving overall survival in patients.
Pembrolizumab is an established medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this study, it is combined with chemotherapy to assess its impact on overall survival in patients with metastatic squamous non-small cell lung cancer.
Carboplatin is a chemotherapy drug used to treat various types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is used in combination with other medications to treat lung cancer.
Paclitaxel is a chemotherapy medication that helps stop the growth of cancer cells by inhibiting cell division. It is used in this study as part of a combination therapy for treating lung cancer.
Nab-paclitaxel is a form of paclitaxel that is bound to a protein called albumin. This formulation allows for better delivery of the drug to cancer cells. It is used in this trial in combination with other treatments for lung cancer.
Metastatic Squamous Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the squamous cells, which are flat cells lining the airways of the lungs. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. The term “metastatic” indicates that the cancer has spread from the lungs to other parts of the body. As the disease progresses, it can affect various organs and tissues, leading to a range of symptoms depending on the areas involved. The progression of this cancer can vary, with some patients experiencing rapid spread while others may have a slower progression. The disease is often diagnosed at an advanced stage due to its subtle early symptoms.
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