Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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:
- * 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
- * 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
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No