Erlotinib beyond progression study: Randomized phase II study comparing chemotherapy plus erlotinib with chemotherapy alone in EGFR TKI-responsive, advanced non-small cell lung cancer (NSCLC) that subsequently progresses.

TPS211 Background: EGFR-driven NSCLCs are dependent on the EGFR pathway for proliferation which EGFR TKIs potently block. Progression occurs when resistance to erlotinib develops—through the emergence of EGFR—T790M or MET gene amplification. This event is likely specific to any given individual tumor clone and therefore on relapse only some tumor clones carry resistance mutations, others likely remain dormant while the EGFR pathway is inhibited providing rationale for maintenance therapy. This concept is supported by clinical observations demonstrating of “tumor flares” in patients taken off of EGFR TKI therapy on progression. Similar analogies exist in prostate cancer/maintenance of castrate state, breast cancer/maintenance trastuzumab. This study seeks preliminary evidence that such a strategy can lead to meaningful benefits in advanced non-small cell lung cancer. Methods: Randomized, phase II study of pemetrexed chemotherapy versus pemetrexed chemotherapy plus erlotinib in patients who derived a clinic...