PF-00299804 (PF299) patient (pt)-reported outcomes (PROs) and efficacy in adenocarcinoma (adeno) and nonadeno non-small cell lung cancer (NSCLC): A phase (P) II trial in advanced NSCLC after failure of chemotherapy (CT) and erlotinib (E).

7596 Background: Treatment (tx) options are limited for pts with NSCLC after failure of CT and E. Cough, dyspnea, and pain (chest) are key pt-reported NSCLC symptoms (symp). PF299 is an oral, irreversible, small-molecule pan-human epidermal growth factor receptor (-1, -2, and -4) tyrosine kinase inhibitor. Methods: This open-label, single-stage, P2 trial evaluated PF299 efficacy in pts with KRAS wild-type advanced NSCLC after failure of ≥1 CT regimen and E. Pts (adeno and nonadeno) received 45 mg PF299 once daily (3-week [wk] cycles [C]). Endpoints included response (primary), safety/tolerability, and PROs assessed by the EORTC-QLQ-C30/LC13 on day (D) 1 of each C (improvement of > 5 points [p] indicates meaningful benefit). Results: 65 pts (37 female, 50 adeno) have enrolled. Of 62 evaluable pts, 3 had a partial response and 35 stable disease (SD) ≥ 6 wks. 28 pts remained on treatment (tx) at C4D1 and had complete PRO data. Common tx-related adverse events (TRAEs) included diarrhea (86%), fatigue (40%), r...