Thoracic Program Trial Selection Protocol
The Thoracic Program Trial Selection Pre-Screening Protocol expedites the screening process, avoids additional invasive biopsies, and avoids delays in treatment initiation while patients will still have their tumor tissue and blood collected according to the standard practices required by most of the thoracic therapeutic clinical trials
The primary objective of this screening study is to assess the feasibility to identify and match patients to a therapeutic clinical trial and to evaluate the screening success rates for therapeutic clinical trials as measured by number of patients who enroll into a therapeutic clinical trial divided by the number of patients who signed informed consent.This protocol will also evaluate the time between informed consent signature (for a clinical trial) to treatment start on a therapeutic clinical trial. Exploratory objectives are to evaluate the time to enrollment on a subsequent therapeutic clinical trial and to evaluate the utility of circulating tumor DNA (ctDNA) genotyping for screening for clinical trial enrollment.
- Provision of signed and dated informed consent document
- Suspected or confirmed diagnosis of thoracic malignancies, including non- small cell lung cancer, small cell cancer, thymic carcinoma, thymoma, and mesothelioma
- Suspected or confirmed clinical stages I-IV
- In good general health as evidenced by medical history with an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Age > 18 years
- Willing to undergo systemic therapy on a clinical trial
- Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Adequate organ function per protocol
- Known HIV positive patients who meet the following criteria will be considered eligible:
- CD4 count > 350 cells/mm3
- Undetectable viral load within the last six months
- HIV positive patients must be stable on HAART
- No active Acquired Immune Deficiency Syndrome (AIDS)-defining opportunistic infections
- For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and achieve sustained viral remission (SVR), i.e., undetectable viral load.
- Patients with a history of a prior or concurrent malignancy, whose natural history does not have the potential to interfere with the safety and efficacy of future investigational agents are eligible
- Ability to understand and willingness to sign a written informed consent document.
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.