Implantable Microdevices for in Situ Evaluation of Drug Responses in Lung Cancer

This pilot research study is being conducted to evaluate the safety and feasibility of implanting and retrieving investigational drug-releasing microdevices in tumors of patients with lung cancer or malignant mesothelioma. The study will also explore the potential of these microdevices as a tool to assess how individual tumors respond to multiple anticancer drugs and drug combinations. The microdevices are designed to release very small quantities (microdoses) of selected anticancer drugs directly into spatially distinct regions of a tumor. The drugs evaluated may include treatments currently approved for lung cancer or mesothelioma, as well as drugs approved for other cancer types that are being investigated as potential treatments for these diseases. The purpose of this localized drug exposure is to measure biological responses within the tumor tissue, rather than to provide therapeutic treatment. The study involves implanting one or more microdevices, each small enough to fit within the tip of a needle, directly into an accessible tumor. The microdevices release microdoses of anticancer drugs through passive diffusion into the surrounding tumor tissue. Drug exposure is intended to remain localized to small regions of the tumor, with minimal systemic exposure. After approximately 3 days, the microdevices and small regions of surrounding tumor tissue will be retrieved through a planned biopsy or surgical procedure. The collected tissues will be analyzed to evaluate local tumor responses to the individual drugs or drug combinations, including changes in tumor cell viability, cell death, and other biological markers of drug activity. Research procedures may include screening for eligibility, clinical evaluations, imaging studies, microdevice implantation, tumor tissue sampling, blood collection, and follow-up visits. The primary objectives of the study are to evaluate the safety and technical feasibility of microdevice implantation, localized drug delivery, and device retrieval in patients with lung cancer or mesothelioma. Exploratory objectives include characterizing tumor responses to multiple anticancer drugs and identifying biological markers associated with drug sensitivity or resistance. The microdevice is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of any disease. The microdevice-based drug testing procedure is experimental and is not intended to provide direct therapeutic benefit to participants. Participation in this research study is expected to last up to 4 months. Approximately 20 participants are expected to enroll, including 10 participants in each of two study cohorts.