A randomized, controlled, multi-center phase 2b trial to review our oral itraconazole in combination with existing standard of care chemotherapy. The primary objective of this trial is to evaluate the ability to delay disease progression in patients with advanced, non-squamous, non-small cell lung cancer. Trial design to be agreed upon in the next IND meeting with the FDA.
Following the IND meeting additional key milestones include FDA concurrence to follow the 505(b)(2) regulatory pathway within NS NSCLC based on the IND clearance. We will also be pursuing FDA Fast Track and/or Breakthrough Therapy Designation status based on the progression-free survival benefit in patients with late-stage NS NSCLC.