Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

Advanced Non-Small Cell Lung Cancer
Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy
Adults over 18 years
Performance status (Eastern Cooperative Oncology Group) less than or equal to 2
Life expectancy greater than 2 months
Laboratory Values:

Hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater than 50,000 Liver function tests less than or equal to twice upper limit of normal Serum Creatinine less than or equal to 2 Creatinine clearance greater than or equal to 30 mL per minute Hemoglobin A1C less than 7 Normal Thyroid function

No history of hyperthyroidism
Abstinence from alcohol and supplements
Not pregnant, lactating and willing to use birth control throughout study
Able to provide consent
Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline

Exclusion Criteria:

Prior use of Withania somnifera
Phenylketonuria
Inability to swallow capsules
Hypersensitivity to study drug ingredients
Unstable medical or surgical condition
History of additional cardiac risk factors
Requiring drugs that are "strong" inhibitors of cytochrome P450
Requiring irradiation
Requiring intravenous fluids or hyperalimentation
Requiring transfusions, dialysis, or other procedures
Active infection
Human Immunodeficiency Virus
Must exceed washout period of prior treatments
Psychiatric, neurological or other reason that precludes subjects ability to participate