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Study of Antroquinonol in Non-Squamous NSCLC

Clinical Trial Title: 
A single-arm, open-label, phase II trial evaluating the efficacy, safety and pharmacokinetics of antroquinonol in patients with stage IV (including pleural effusion) non-squamous NSCLC who have failed two lines of anti-cancer therapy.
Clinical Trial Protocol ID: 
13102301
Clinical Trial Investigator Name: 
Mary Jo Fidler, MD
Clinical Trial Protocol Description: 

This is a study in KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous non-small cell lung cancer (NSCLC) who have failed two lines of anti-cancer therapy. A maximum of 60 patients with NSCLC will receive antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An evaluable patient will have received at least one dose of antroquinonol and have a valid baseline tumor assessment.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Be diagnosed with non-squamous non-small cell lung cancer (NSCLC) Stage IV (including pleural effusion).
  • Be at least 18 years of age.

You will be excluded from the study if any of the following criteria apply to you:

  • Have brain metastases which are symptomatic.
  • Have inability to swallow oral medications or recent acute gastrointestinal disorder with diarrhea.
  • Have a history of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia.
  • Have any serious active infection.

This is a partial list of inclusion and exclusion criteria. 

Clinical Trial Area: 
Lung and Chest Tumors
Contact Phone: 
(312) 563-3347
Contact Name: 
Deborah Pach, RN