A randomized phase III study of maintenance therapy with bevacizumab (B), pemetrexed (Pm), or a combination of bevacizumab and pemetrexed (BPm) following carboplatin, paclitaxel and bevacizumab (PCB) for advanced nonsquamous NSCLC: ECOG trial 5508 (NCT01107626)

TPS218 Background: In ECOG 4599, bevacizumab was continued as maintenance therapy following 6 cycles of PCB. This study led to the approval of PCB followed by B for first-line treatment of advanced non-squamous NSCLC by the FDA. Switch maintenance therapy with Pm has recently demonstrated survival benefit for non-squamous NSCLC. Therefore ECOG 5508 will compare the efficacy of continuation of B vs. switch to Pm or the BPm combination after 4 cycles of PCB. Methods: The primary objective is to compare OS with B, Pm or BPm as maintenance therapy in pts with advanced stage NSCLC. Secondary objectives include PFS, response, toxicity and correlative studies focusing on polymorphisms, population pharmacokinetics and expression levels association with these outcomes. Eligibility criteria: ECOG PS 0 or 1 and adequate hematologic, renal and hepatic function, no brain metastases. All eligible pts receive PC (200 mg/m2, AUC=6 on day 1 every 3 wks) + B 15mg/kg day 1 (PCB) every 3 weeks. After 4 cycles pts with CR/PR/...