First-line pemetrexed plus cisplatin followed by maintenance pemetrexed versus carboplatin-paclitaxel plus bevacizumab followed by maintenance bevacizumab (ERACLE) in advanced nonsquamous NSCLC: A quality-of-life-oriented, multicenter randomized phase III trial of the GOIM (Gruppo Oncologico Italia Meridionale).

8071 Background: In absence of oncogenic driver chemotherapy (CT) for advanced non-squamous non-small cell lung cancer (NS-NSCLC) remains palliative with similar efficacy and survival among different regimens. Histotype, maintenance therapy (m) and quality of life (QoL) have been explored to improve patients (pts) outcome. ERACLE trial (NCT01303926), a QoL-oriented phase III trial was designed to compare the QoL for two CT regimens. Methods: Pts with stage IIIB/IV NS-NSCLC (ECOG 0/1) were randomized (1:1) to receive first-line CT. ARM A received 6 cycles of Cisplatin (C) (75 mg/m2) - Pemetrexed (P) (500 mg/m2) q3w, followed by mP (500 mg/m2) while ARM B received Carboplatin (Cb) AUC 6 - Paclitaxel (T) 200 mg/m2plus Bevacizumab (Be) 15 mg/kg q3w for 6 cycles and mBe 15 mg/kg. Both treatments were administered until progression, unacceptable toxicity or death. Stratification was based on Study Centre and disease stage. Co-Primary endpoints were EQ5D Index (EQ5D-I) and EQ5D-VAS (Euro-QoL questionnaire) at 12...