This clinical trial is focused on studying a type of lung cancer known as metastatic non-small cell lung cancer (mNSCLC). The study is comparing two different treatment combinations to see which is more effective. One group of participants will receive a new medication called volrustomig (also known by its code name MEDI5752) along with chemotherapy. The other group will receive a medication called pembrolizumab along with chemotherapy. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells.
The purpose of the study is to determine if the combination of volrustomig and chemotherapy is better at improving the length of time patients live without their cancer getting worse, and overall survival, compared to the combination of pembrolizumab and chemotherapy. Participants will be randomly assigned to one of the two treatment groups. The study will involve regular visits to the clinic for treatment and monitoring. Treatments will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.
This study is designed for patients with mNSCLC whose tumors have a specific characteristic, where a protein called PD-L1 is present at less than 1%. The study will continue for several years to gather enough information to determine the effectiveness of the treatments. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to track the progress of their treatment.
1joining the study
Upon joining the study, the patient will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.
2treatment group assignment
The patient will be assigned to receive either volrustomig in combination with chemotherapy or pembrolizumab plus chemotherapy. Both treatments are designed for patients with metastatic non-small cell lung cancer (mNSCLC).
3treatment administration
If assigned to the volrustomig group, the patient will receive volrustomig through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.
If assigned to the pembrolizumab group, the patient will receive pembrolizumab also through an intravenous infusion.
Both groups will receive additional chemotherapy drugs, which may include pemetrexed, paclitaxel, carboplatin, and mycophenolate mofetil. These drugs are administered either intravenously or orally, depending on the specific medication.
4treatment schedule
The treatment will be administered according to a schedule determined by the study protocol. This schedule will specify the dosage, frequency, and duration of each medication. The healthcare team will provide detailed instructions and support throughout the treatment period.
5monitoring and assessments
Regular monitoring and assessments will be conducted to evaluate the patient’s response to the treatment. This includes imaging tests to check for disease progression and routine health checks to monitor overall well-being.
The primary goals are to assess progression-free survival (PFS) and overall survival (OS). PFS refers to the length of time during and after treatment that the patient lives with the disease without it getting worse. OS refers to the length of time from the start of treatment that the patient is still alive.
6end of study participation
The study is expected to continue until May 2029. Participation may end earlier if the patient experiences significant disease progression or adverse effects, or if they choose to withdraw from the study.
Who Can Join the Study?
The patient must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has spread to other parts of the body, known as metastatic.
The cancer must be confirmed through specific tests called histological or cytological tests, which examine tissue or cell samples.
The cancer must be at Stage IV, which means it is advanced and has spread beyond the lungs.
The patient must provide a sample of their tumor for a test called PD-L1 testing, which helps determine the best treatment options.
The PD-L1 level in the tumor must be less than 50%.
The cancer must not have certain genetic changes called EGFR mutations or ALK and ROS1 rearrangements, which are specific alterations in the cancer cells.
The cancer must not have other specific genetic changes that can be treated with approved targeted therapies, such as NTRK, BRAF, RET, MET, and others.
Both male and female patients can participate.
The study includes patients who are considered part of a vulnerable population, meaning they may need special protection or care.
Who Cannot Join the Study?
Patients with other types of cancer besides Metastatic Non-Small Cell Lung Cancer (mNSCLC) cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients with a PD-L1 level of 1% or higher are not eligible. PD-L1 is a protein that can affect how the immune system responds to cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
Patients who have any medical conditions or are taking medications that might interfere with the study treatments are not eligible.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain health conditions that could make the study treatments unsafe for them are not eligible.
Volrustomig (MEDI5752) is an investigational medication being studied for its potential to treat metastatic non-small cell lung cancer (mNSCLC). It is being tested in combination with chemotherapy to see if it can improve progression-free survival (PFS) and overall survival (OS) in patients whose tumors have low levels of a protein called PD-L1.
Pembrolizumab is a medication already used in the treatment of various types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells. In this study, pembrolizumab is combined with chemotherapy to compare its effectiveness against the combination of volrustomig and chemotherapy.
Metastatic Non-Small Cell Lung Cancer (mNSCLC) – This is a type of lung cancer that has spread beyond the lungs to other parts of the body. It originates from the epithelial cells in the lungs and is characterized by its non-small cell nature, which differentiates it from small cell lung cancer. The disease progresses as cancer cells grow and invade nearby tissues, eventually entering the bloodstream or lymphatic system to reach distant organs. Symptoms may include persistent cough, chest pain, and difficulty breathing, which worsen as the disease advances. The progression of mNSCLC can vary, with some patients experiencing rapid spread while others may have a slower disease course.
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