This clinical trial is focused on studying a type of lung cancer known as Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study will compare the effects of a medication called Sacituzumab Govitecan, also known by its brand name Trodelvy, with the standard treatments currently used for this type of cancer. Sacituzumab Govitecan is a special kind of treatment called an Antibody-Drug Conjugate, which is designed to target and attack cancer cells more precisely.
The purpose of the study is to see how well Sacituzumab Govitecan works compared to the usual treatments in improving the condition of patients with ES-SCLC. Participants in the study will receive either Sacituzumab Govitecan or the standard treatment, which may include other medications. The study will monitor how the cancer responds to the treatment and how long patients live after receiving the treatment. Some participants may receive a placebo as part of the study.
The study will take place over a period of time, with regular check-ups and assessments to track the progress of the treatment. Participants will receive their treatment through an intravenous method, which means the medication will be given directly into a vein. The study aims to provide valuable information on the effectiveness of Sacituzumab Govitecan in treating ES-SCLC and to explore its potential as a new treatment option for patients with this type of lung cancer.
1joining the study
Upon joining the study, you will be randomly assigned to receive either the new treatment, sacituzumab govitecan, or the current standard of care for your condition. This process is called randomization and ensures that the study results are unbiased.
2treatment administration
If you are assigned to the sacituzumab govitecan group, you will receive the medication as an intravenous infusion. This means the medication will be given directly into your vein through a needle.
The dosage for sacituzumab govitecan is 200 mg, and it will be administered as a solution for infusion. The frequency and duration of the treatment will be explained to you by the study team.
If you are assigned to the standard of care group, you will receive the current treatment used for extensive stage small cell lung cancer, which may also involve intravenous administration.
3monitoring and assessments
Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests such as CT or MRI scans to assess the response of your cancer to the treatment.
The study team will evaluate the effect of the treatment on your cancer using specific criteria to determine if there is a complete or partial response.
4reporting side effects
You will be asked to report any side effects or changes in your health to the study team. This information is crucial for understanding the safety of the treatment.
The study team will also monitor for any treatment-emergent adverse events, which are side effects that occur after the treatment has started.
5end of study participation
Your participation in the study will continue until the study ends or until you and the study team decide it is best for you to stop. The estimated end date for the study is November 1, 2029.
At the end of your participation, you will have a final assessment to evaluate your overall health and the effect of the treatment on your cancer.
Who Can Join the Study?
Must have a confirmed diagnosis of Small Cell Lung Cancer (SCLC).
Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
Must have a disease that can be measured by computed tomography (CT) or magnetic resonance imaging (MRI). These are imaging tests that help doctors see inside the body.
Must have documentation showing that the disease has gotten worse after receiving at least one previous treatment with platinum-containing chemotherapy. This treatment should have included at least two cycles. It may have been given with or without therapy targeting programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1). These are proteins that can affect the immune system’s ability to fight cancer.
Participants can be of any gender.
Participants must be within the age range of adults and older adults.
Who Cannot Join the Study?
Patients with any other type of cancer besides Extensive Stage Small Cell Lung Cancer (ES-SCLC) cannot participate.
Patients who have not fully recovered from previous cancer treatments are excluded.
Patients with severe heart problems are not eligible.
Patients with uncontrolled infections cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients with brain metastases that are causing symptoms are not eligible. Brain metastases are cancer cells that have spread to the brain.
Patients who have received another investigational drug within the last 4 weeks cannot participate.
Patients with autoimmune diseases that are not well controlled are excluded. Autoimmune diseases are conditions where the immune system attacks the body.
Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
Sacituzumab Govitecan is a medication being studied for its potential to treat extensive stage small cell lung cancer that has already been treated with other therapies. It works by combining an antibody with a chemotherapy drug. The antibody part of the medication helps to target and attach to cancer cells, while the chemotherapy part helps to kill these cells. This combination aims to improve the response to treatment and potentially extend the life of patients with this type of lung cancer.
Extensive Stage Small Cell Lung Cancer (ES-SCLC) – This is a type of lung cancer characterized by the rapid growth and spread of small cells in the lung tissue. It is called “extensive stage” when the cancer has spread beyond the lung to other parts of the body. The disease progresses quickly, often involving the lymph nodes and other organs. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and systemic symptoms. The progression is typically aggressive, with a tendency to metastasize early in its course.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Belgium 
France 
Germany 
Greece 
Hungary 
Italy 
Norway 
Poland 
Romania 
Spain 
The Netherlands