Clinical Research Directory

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

The goals of this prospective, observational cohort study are to determine the feasibility of implementing paclitaxel therapeutic drug monitoring for cancer patients and explore the relationship between paclitaxel drug exposure and the development of neuropathic symptoms. This trial studies if paclitaxel can be consistently measured in the blood of patients with solid tumors undergoing paclitaxel treatment. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nerve damage is one of the most common and severe side effects of paclitaxel. The ability to consistently measure paclitaxel in the blood may allow doctors to control the dose of paclitaxel, so that enough chemotherapy is given to kill the cancer, but the side effect of nerve damage is reduced.

Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)

Patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% are commonly treated with different chemo-immunotherapy regimens in routine clinical practice. Although these regimens are widely used, comparative real-world data on survival outcomes and patient-reported quality of life are limited. This prospective observational study aims to compare two commonly used treatment approaches in patients with metastatic NSCLC and PD-L1 expression \<50%: chemotherapy plus pembrolizumab versus nivolumab plus ipilimumab combined with chemotherapy. Patients will receive treatment according to routine clinical decisions made by their treating physicians; no treatment assignment or intervention will be performed as part of the study. The primary outcomes of the study are progression-free survival and overall survival. In addition, health-related quality of life will be assessed using validated patient-reported outcome questionnaires during routine follow-up. Exploratory analyses will examine treatment outcomes in relation to selected clinical and patient-related factors, such as biological age, antibiotic exposure, and dietary patterns, in subsets of patients with available data. The results of this study are expected to provide real-world evidence on survival and quality of life outcomes associated with commonly used chemo-immunotherapy strategies in metastatic NSCLC.

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic non small cell lung cancer (NSCLC).