Study of Datopotamab Deruxtecan, Durvalumab, and Carboplatin for Advanced Non-Small Cell Lung Cancer in Patients Without Actionable Genomic Alterations
This clinical trial is focused on studying treatments for Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study will compare two different treatment combinations. One group will receive a combination of Datopotamab Deruxtecan (also known as DS-1062a), Durvalumab (also known as MEDI4736), and Carboplatin. The other group will receive Pembrolizumab along with a type of chemotherapy that includes platinum-based drugs. The purpose of the study is to see which combination works better for patients with advanced NSCLC that does not have certain genetic changes known as actionable genomic alterations.
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 monitor how long patients live without their cancer getting worse, as well as their overall survival. The study will also look at how well the cancer responds to the treatment and how long any positive effects last.
The study aims to provide important information about the effectiveness of these treatment combinations for patients with advanced NSCLC. By comparing these treatments, researchers hope to find the best option for managing this type of lung cancer. The study will continue for several years to gather enough data to make informed conclusions about the treatments’ benefits and safety.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of lung cancer, and overall health status.
Participants must have non-small cell lung cancer (NSCLC) that is advanced or metastatic and lacks certain genetic mutations.
2randomization
Participants are randomly assigned to one of two treatment groups.
One group receives datopotamab deruxtecan in combination with durvalumab and carboplatin, while the other group receives pembrolizumab with platinum-based chemotherapy.
3treatment administration
Treatment is administered through intravenous infusion, which means the medication is given directly into a vein.
The specific dosage and frequency depend on the treatment group and the individual treatment plan.
4monitoring and assessments
Regular monitoring is conducted to assess the response to treatment and any side effects.
Assessments include imaging tests to evaluate cancer progression and routine blood tests to check overall health.
5follow-up
Participants continue to be monitored for progression-free survival, which is the time during and after treatment that the cancer does not get worse.
Overall survival is also tracked, which is the time from the start of the study until death from any cause.
6end of study
The study is estimated to conclude in February 2027.
Final assessments are conducted to gather data on the effectiveness and safety of the treatments.
Who Can Join the Study?
Participants must be 18 years or older at the time of screening.
Must have Non-Small Cell Lung Cancer (NSCLC) that is either locally advanced or has spread to other parts of the body (metastatic). The cancer should not be treatable with surgery or a combination of chemotherapy and radiation.
The cancer should not have certain genetic changes, such as EGFR, ALK, ROS1, NTRK, BRAF, RET, MET, or other specific genes that have approved treatments. Testing for these changes is not needed for certain types of lung cancer, with some exceptions.
Must have an ECOG Performance Status of 0 or 1, which means the participant is fully active or has some symptoms but can still carry out light work.
Must provide a sample of the tumor tissue from a previous biopsy or surgery.
Must have enough healthy bone marrow and properly working organs, as shown by tests done within 7 days before joining the study.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Non-Small Cell Lung Cancer (NSCLC).
Patients who do not have the TROP2 biomarker in their cancer. A biomarker is a substance in the body that can indicate the presence of a disease.
Patients who have already received treatment for their lung cancer.
Patients who are not in the age range specified for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had an allergic reaction to any of the study drugs or similar drugs in the past.
Patients who have an active infection that requires treatment.
Patients who have a history of certain heart problems.
Patients who have a history of certain lung problems not related to cancer.
Patients who have a history of certain immune system problems.
Patients who have a history of drug or alcohol abuse.
Patients who have received a live vaccine within a certain time before starting the study.
Datopotamab Deruxtecan (Dato-DXd) is an experimental medication being studied for its potential to treat certain types of lung cancer. It is designed to target and deliver chemotherapy directly to cancer cells, which may help to reduce the growth of tumors.
Durvalumab is a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells. It is used in combination with other treatments to enhance the body’s natural defenses against cancer.
Carboplatin is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is commonly used to treat various types of cancer, including lung cancer.
Pembrolizumab is another form of immunotherapy that boosts the immune system’s ability to fight cancer. It is often used in combination with other treatments to improve outcomes for patients with advanced cancer.
Platinum-based Chemotherapy refers to a group of chemotherapy drugs that contain platinum, which are used to damage the DNA of cancer cells and stop them from multiplying. These drugs are often used in combination with other treatments to enhance their effectiveness against cancer.
Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.
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