This clinical trial is focused on studying a type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC) that has specific characteristics: it overexpresses a protein called c-Met and does not have mutations in a gene called EGFR. The study is comparing two treatments for this cancer. One treatment is called Telisotuzumab Vedotin, also known by its code name ABBV-399, which is given as a solution for injection. The other treatment is Docetaxel, which is a concentrate for solution for infusion. Both treatments are administered through an intravenous infusion, meaning they are given directly into a vein.
The purpose of the study is to evaluate how effective Telisotuzumab Vedotin is compared to Docetaxel in terms of how long patients live without the cancer getting worse and overall survival. Participants in the study will receive one of these treatments and will be monitored over a period of time to see how their cancer responds. The study will also look at other factors such as the response rate to the treatment, how long any response lasts, and changes in quality of life, including symptoms like cough, pain, and difficulty breathing.
This study is designed for patients who have already received treatment for their lung cancer but need further therapy. It aims to provide more information on the effectiveness and safety of these treatments for this specific type of lung cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the outcomes of the treatments.
1joining the study
Upon joining the study, the patient will be assessed to confirm eligibility. This includes verifying the presence of c-Met overexpressing non-squamous non-small cell lung cancer (NSCLC) and ensuring the patient has progressed on at least one prior therapy for locally advanced or metastatic NSCLC.
The patient must have a negative test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and provide tumor material for assessment of c-Met levels.
2treatment assignment
The patient will be randomly assigned to receive either Telisotuzumab Vedotin or Docetaxel. Both medications are administered as an intravenous infusion.
The specific medication and dosage will be determined based on the study protocol and the patient’s condition.
3treatment administration
The patient will receive the assigned medication through an intravenous infusion. The frequency and duration of administration will be specified in the study protocol.
Regular monitoring will occur to assess the patient’s response to the treatment and to manage any side effects.
4progress evaluation
The patient’s progress will be evaluated based on progression-free survival and overall survival. These are the primary endpoints of the study.
Secondary endpoints include the objective response rate, duration of response, and changes in quality of life as measured by specific questionnaires.
5completion of study
The study is estimated to end by March 21, 2028. The patient’s participation will continue until the study’s completion or until the patient meets criteria for discontinuation.
Upon completion, the patient’s overall health and response to the treatment will be reviewed.
Who Can Join the Study?
The patient must have a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that shows high levels of a protein called c-Met.
The patient must have already tried at least one treatment for advanced or spreading NSCLC and it didn’t work. This includes:
For patients without certain gene changes, they must have tried or be unable to try chemotherapy with a drug called platinum and a type of treatment called an immune checkpoint inhibitor.
For patients with certain gene changes, they must have tried or be unable to try treatments targeting those gene changes and platinum-based chemotherapy.
For patients with gene changes where immune checkpoint inhibitors are standard, they must have tried or be unable to try these inhibitors.
The patient must be suitable for treatment with a drug called docetaxel, as decided by their doctor.
The patient must not have an active infection with the virus SARS-CoV-2 (the virus that causes COVID-19). If they have symptoms, they must test negative for the virus.
The patient must provide a sample of their tumor for testing to check the levels of the c-Met protein.
The patient must have good function of their bone marrow, kidneys, and liver.
The patient must have a confirmed diagnosis of non-squamous NSCLC that is advanced or has spread.
The patient must know their EGFR mutation status. Patients with certain EGFR mutations are not eligible.
Patients with changes in genes other than EGFR are eligible.
The patient must have a tumor that can be measured according to specific guidelines.
The patient must have a good general health status, with an ECOG Performance Status of 0 to 1, which means they are fully active or have some symptoms but can still do light work.
The patient must not have had more than one previous treatment with chemotherapy for advanced or spreading cancer. If they had chemotherapy before surgery or after surgery and the cancer came back within 6 months, it counts as a previous treatment.
Both male and female patients are eligible to participate.
Who Cannot Join the Study?
Patients who do not have C-Met overexpressing EGFR wildtype non-squamous non-small cell lung cancer cannot participate. This means the specific type of lung cancer must be present.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population are not excluded, meaning those who might need special protection are considered.
Telisotuzumab Vedotin (ABBV-399) is an investigational medication being studied for its potential to treat certain types of lung cancer. It is designed to target and bind to a protein called c-Met, which is often overexpressed in some cancer cells. By attaching to these cells, telisotuzumab vedotin aims to deliver a toxic substance directly to the cancer, helping to kill the cancer cells while minimizing damage to normal cells.
Docetaxel is a chemotherapy medication commonly used to treat various types of cancer, including lung cancer. It works by interfering with the growth and division of cancer cells, ultimately leading to their death. In this trial, docetaxel is used as a standard treatment to compare its effectiveness against the investigational medication, telisotuzumab vedotin.
Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and potentially spread to other parts of the body. In the context of c-Met overexpressing, EGFR wildtype, non-squamous NSCLC, the cancer cells have specific genetic characteristics that influence their behavior and response to treatment. The progression of NSCLC can vary, with some cases advancing more rapidly than others.
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