Huntley

Researchers are evaluating durvalumab, an immunotherapy drug, compared to the usual approach of patient observation after surgery in people with early-stage non-small cell lung cancer (NSCLC) who have no remaining cancer cells following standard treatment. This phase III trial aims to determine if durvalumab can improve disease-free survival and overall survival, as well as assess its safety and impact on quality of life. The study focuses on participants with stage II to IIIB NSCLC who achieved a complete response after neoadjuvant chemo-immunotherapy and surgery. Participants are randomly assigned to one of two groups: one group receives durvalumab intravenously every 28 days for up to 12 cycles if there is no disease progression or unacceptable side effects, while the other group undergoes active surveillance without additional treatment for 12 months. Both groups have regular computed tomography (CT) scans and blood sample collections during the study. After treatment or surveillance, participants are followed annually for up to 10 years. Throughout the study, participants complete questionnaires about their quality of life and report symptoms such as rash or numbness. Researchers monitor disease recurrence, new lung cancers, or death, as well as treatment side effects. Specimens and images are collected for future research. The total participation time includes treatment or observation plus long-term follow-up visits to assess the effects and safety of durvalumab compared to observation alone.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.