This clinical trial is focused on studying Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study will compare two treatments: SGN-B6A and docetaxel. SGN-B6A is a new treatment that involves a special type of protein called a monoclonal antibody, which is designed to target cancer cells. It is combined with a drug that helps kill these cells. Docetaxel is a chemotherapy medication that is already used to treat various cancers, including lung cancer.
The purpose of the study is to see which treatment is more effective for patients who have already received treatment for their lung cancer. Participants will be randomly assigned to receive either SGN-B6A or docetaxel. The study will monitor how well each treatment works in terms of overall survival and response to the treatment. This means researchers will look at how long patients live and how their cancer responds to the treatment.
Throughout the study, participants will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 60 days, during which time participants will be closely monitored by the research team. The goal is to gather information that could help improve treatment options for people with Non-Small Cell Lung Cancer.
1joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the experimental treatment called SGN-B6A, and the other group will receive a standard treatment called docetaxel.
2treatment administration
If you are in the SGN-B6A group, you will receive this 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 in the docetaxel group, you will also receive this medication through an intravenous infusion. The dosage and frequency will be determined by the medical team based on your individual needs.
3monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This may include physical examinations, blood tests, and imaging studies such as CT scans.
The study aims to compare the overall survival and response rates between the two treatment groups. Your health and any changes in your condition will be closely monitored by the medical team.
4quality of life evaluations
You will be asked to complete questionnaires about your quality of life. These questionnaires will help assess how the treatment affects your daily activities and overall well-being.
The questionnaires will cover topics such as physical functioning, role functioning, and symptoms like cough and chest pain.
5completion of the study
The study is expected to continue until November 2028. Your participation may last until the study ends or until you and the medical team decide it is best for you to stop.
Upon completion, the results will be analyzed to determine the effectiveness and safety of the treatments.
Who Can Join the Study?
Must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body.
The cancer must be of a type called nonsquamous. This means it should not have a squamous or mostly squamous appearance, and it should not have small cell elements.
Can have NSCLC with known Actionable Genetic Alterations (AGAs), such as EGFR mutations or ALK translocations. These are specific changes in the cancer’s genes that can be targeted by certain treatments.
Must have received certain treatments before joining the study:
If there are no known AGAs, must have received a combination of platinum-based chemotherapy and a PD-(L)1 monoclonal antibody, unless not suitable. This treatment could have been given together or one after the other.
If the cancer progressed within 6 months after the last dose of platinum-based chemotherapy for early or locally advanced disease, must have received a PD-(L)1 monoclonal antibody at any time during treatment.
If there are known AGAs, must have received at least one targeted therapy for these genetic changes and, in the opinion of the doctor, further targeted therapy is not the best option.
Must have received only one platinum-based chemotherapy regimen and may have received one PD-(L)1 monoclonal antibody, either together with or after the chemotherapy.
Both men and women can participate.
Participants should not be part of a vulnerable population.
Who Cannot Join the Study?
Patients with any other type of cancer besides Non-Small Cell Lung Cancer (NSCLC) cannot participate.
Patients who have received certain treatments for cancer recently may not be eligible.
Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with known allergies to the study drugs or similar drugs are excluded.
Patients with a history of certain heart conditions may not be eligible.
Patients who have had a major surgery recently may not be eligible.
Patients with active infections that require treatment are excluded.
Patients with a history of drug or alcohol abuse may not be eligible.
SGN-B6A is an experimental medication being tested in this clinical trial. It is designed to target and treat non-small cell lung cancer, a type of lung cancer that has been previously treated but needs further management. The goal of using SGN-B6A is to see if it can help patients live longer and improve their response to treatment compared to the standard treatment option.
Docetaxel is a well-known chemotherapy drug used in the treatment of various cancers, including non-small cell lung cancer. In this trial, it serves as the standard treatment option against which the new experimental medication, SGN-B6A, is being compared. Docetaxel works by interfering with the growth of cancer cells, ultimately leading to their destruction. The trial aims to determine if the new medication can provide better outcomes than docetaxel.
Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and potentially spread to other parts of the body. The progression of NSCLC can vary, with some tumors growing slowly while others may grow more rapidly. Symptoms often include persistent cough, chest pain, and difficulty breathing. The disease is more common in smokers, but it can also occur in non-smokers.
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