Phase 0/1 of Positron Emission Tomography (PET) imaging agent [18F]-ODS2004436 as a marker of EGFR mutation in patients with non-small cell lung cancer (NSCLC)

e24184Background: Multiple EGFR tyrosine kinase inhibitors (TKIs) are approved for treatment of NSCLC harboring EGFR activating mutations or secondary TKIs resistant mutation. We evaluate a new PET radiotracer targeting specifically activated EGFR in a phase 0/1 clinical trial (NCT02847377) to be used as dynamic imaging biomarker to determine and predict responsiveness to EGFR TKI. Methods: This phase 0/I trial is divided into 3 steps according to the genetic profile of patients with NSCLC. Step 1: inclusion of 8 patients harboring EGFR mutation. PET with [18F]-ODS2004436 radiotracer is performed at day 0 (baseline) before treatment, and 7 days after beginning of treatment by EGFR TKI in order to calculate changes of the tumor radiotracer uptake. A significant tumor uptake on at least 6 patients with EGFR mutation is required (sensibility u003e 75%). Step 2: enrollment of 6 patients without EGFR mutation (WT). PET will be performed only at baseline. Step 3: enrollment of 4 others patients with EGFR mutation. ...