The Neuroendocrine Effects of Pioglitazone in Patients With Lung Cancer and Cachexia (TRACE-1)

Inclusion Criteria: Age ≥18 years Documented histologic or cytologic diagnosis of non-small-cell lung cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs) Cachexia defined by Fearon criteria Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures Provide written approval by a qualified healthcare professional Allow the collection and storage of biospecimens and data for future use Exclusion Criteria: Prior diagnosis of type 2 diabetes Prior or current thiazolidinedione (TZD) therapy Known hypersensitivity to TZD New York Heart Association (NYHA) class I-IV heart failure History of or actively treated bladder cancer Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin) Inadequate hepatic function Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant) Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol