General physical health deterioration Trials in Disease

Study on Durvalumab for Patients with Poor General Condition and Advanced Non-Small Cell Lung Cancer

This trial is investigating the use of Durvalumab (also known as MEDI4736) in patients with advanced non-small cell lung cancer who have experienced a decline in their overall physical health. This study is particularly important because it focuses on patients who are often excluded from other clinical trials due to their poor health status.

Main inclusion criteria: The trial is open to adults between 18 and 75 years of age who have been diagnosed with stage IV non-small cell lung cancer that has spread to other parts of the body. Participants must have tumors showing high levels of PD-L1 protein (at least 25% of cells) and must not have received previous treatment for their advanced cancer. Importantly, participants must have an ECOG performance status of 2 or 3, meaning they have limited ability to perform daily activities despite receiving the best symptom treatment. They must weigh more than 30 kilograms and have adequate function of major organs including bone marrow, kidneys, and liver. Women of childbearing age must use effective birth control methods.

Main exclusion criteria: The trial excludes patients who do not have non-small cell lung cancer or whose tumors do not show high PD-L1 expression. Patients who fall outside the specified age range or who have received previous systemic cancer treatment for advanced disease cannot participate. Those with certain genetic changes in their tumors, specifically EGFR mutations or ALK gene rearrangements, are also excluded.

Focus and goals: The primary goal of this study is to evaluate both the safety and effectiveness of Durvalumab in patients with poor general health status. Researchers will monitor how well patients tolerate the treatment and whether it helps control the disease. After 8 weeks of treatment, doctors will assess the disease control rate to see if the cancer has responded to treatment or remained stable. The study will also measure progression-free survival, which is how long patients live without their disease getting worse, as well as overall survival rates. Quality of life will be assessed using questionnaires to understand how the treatment affects patients' daily living and well-being.

Investigational treatment: Durvalumab is an anti-PD-L1 monoclonal antibody, a type of immunotherapy that works by blocking the PD-L1 protein on cancer cells. This blocking action helps the immune system recognize and attack cancer cells more effectively. The medication is delivered directly into the bloodstream through an intravenous infusion. Treatment begins within 7 days of joining the study and continues for up to 24 months, with regular monitoring visits scheduled throughout. The trial is expected to conclude by October 2025, at which point researchers will perform a comprehensive analysis of the data to determine the overall effectiveness and safety of this approach.