This clinical trial is focused on studying treatments for advanced or metastatic non-small cell lung cancer, a type of lung cancer that has spread beyond the lungs. The study involves several medications, including Datopotamab Deruxtecan (also known as Dato-DXd), Pembrolizumab (also known as Keytruda), and platinum-based chemotherapy drugs like Carboplatin, Pemetrexed, and Cisplatin. These treatments are administered as solutions for infusion, meaning they are given directly into the bloodstream through a vein.
The purpose of the study is to compare the effectiveness of different combinations of these treatments. Participants will receive either a combination of Dato-DXd and Pembrolizumab, with or without platinum-based chemotherapy, or a combination of Pembrolizumab, Pemetrexed, and platinum-based chemotherapy. The study aims to determine which combination works best in controlling the cancer and improving survival.
Participants in the study will receive their assigned treatments over a period of time, with regular monitoring to assess how the cancer responds to the treatment. The study will also involve the use of a placebo in some cases. The trial is designed to provide valuable information on the best treatment options for patients with this type of lung cancer, helping to improve future care and outcomes.
1joining the study
Upon joining the study, you will be required to sign and date the informed consent form. This confirms your willingness to participate and comply with the study’s procedures and restrictions.
2initial assessments
You will undergo initial assessments to confirm eligibility. This includes providing a tumor tissue sample for testing and undergoing imaging assessments to measure the disease.
3randomization
You will be randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the study treatments.
4treatment administration
You will receive the study medications through an intravenous infusion. The medications include pembrolizumab, datopotamab deruxtecan, and possibly a platinum-based chemotherapy such as carboplatin, pemetrexed, or cisplatin.
The frequency and duration of the treatment will be determined by the study protocol and your assigned treatment group.
5regular monitoring
Throughout the study, you will have regular visits for monitoring. This includes laboratory tests, imaging assessments, and evaluations of your overall health and response to the treatment.
6end of treatment
At the end of the treatment period, you will undergo final assessments to evaluate the outcomes of the study treatment.
7follow-up
After completing the treatment, you will have follow-up visits to monitor your health and any long-term effects of the treatment.
Who Can Join the Study?
Sign and date the Main Informed Consent Form (ICF) before starting any study-specific procedures. Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and adhere to other study procedures and restrictions.
Be an adult aged 18 years or older at the time of signing the Main ICF. (If local laws require a higher age for consent, those laws apply.)
Have a tumor with PD-L1 TPS less than 50%. This is determined by a specific test called the PD-L1 IHC 22C3 pharmDx assay, which requires a minimum of six slides for testing.
Provide a sample of the tumor tissue, which is fixed in a substance called formalin. This sample should be at least 10 sections thick (preferably 15) and is used to measure a protein called TROP2 and other exploratory markers. If local laws do not allow sample collection, you can still participate in the study.
Have not received systemic anticancer therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). If you had previous therapy that was completed at least 6 months before the diagnosis of advanced/metastatic disease, and you did not progress during or within 6 months of completing that therapy, you are eligible.
Have measurable disease based on local imaging assessment using a method called RECIST v1.1. This means that the tumor can be measured using imaging tests, and this assessment must be done within 28 days before randomization.
Who Cannot Join the Study?
Patients with a type of lung cancer that is not advanced or metastatic.
Patients whose lung cancer has a PD-L1 TPS score of 50% or higher. PD-L1 TPS is a measure of a protein that can affect how the immune system responds to cancer.
Patients with lung cancer that has specific genetic changes known as actionable genomic alterations. These are changes in the cancer’s DNA that can be targeted with specific treatments.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or are part of a vulnerable population that requires special protection.
Datopotamab Deruxtecan (Dato-DXd) is a type of medication known as an antibody-drug conjugate. It is designed to target and deliver a powerful anti-cancer drug directly to cancer cells. This helps to kill the cancer cells while minimizing damage to healthy cells. In this trial, it is being tested to see how well it works in combination with other treatments for a specific type of lung cancer.
Pembrolizumab is an immunotherapy drug that helps the body’s immune system fight cancer. It works by blocking a protein called PD-1, which can stop the immune system from attacking cancer cells. By blocking this protein, pembrolizumab helps the immune system to recognize and destroy cancer cells more effectively.
Platinum-based Chemotherapy refers to a group of chemotherapy drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, platinum-based chemotherapy is used in combination with other treatments to see if it improves outcomes for patients with lung cancer.
Pemetrexed is a chemotherapy drug that works by interfering with the growth of cancer cells. It does this by blocking the production of certain substances that cancer cells need to grow and divide. In this trial, pemetrexed is used alongside other treatments to evaluate its effectiveness in treating a specific type of lung cancer.
Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations – This type of lung cancer originates in the epithelial cells of the lung and is characterized by the absence of squamous cells. It is classified as advanced or metastatic when it has spread beyond the lungs to other parts of the body. The cancer cells in this condition express less than 50% of the PD-L1 protein, which can affect how the immune system recognizes and attacks the cancer. The disease progresses as the cancer cells continue to grow and spread, potentially affecting various organs and systems. The lack of actionable genomic alterations means that there are no specific genetic mutations that can be targeted with current therapies. As the disease advances, symptoms may worsen, impacting the patient’s quality of life.
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