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• W2891737590 abstract "TPS9116 Background: Dual inhibition of epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) pathway is becoming an encouraging strategy in the treatment of advanced NSCLC. Apatinib is a tyrosine kinase inhibitor that selectively inhibits the VEGF receptor-2. Our phase I study of Apatinib plus Gefitinib has shown a manageable tolerability profile and promising antitumor activity with an anticipated progressive-free survival (PFS) > 14 mos. This phase III study aims to evaluate the efficacy and safety of Apatinib or placebo plus Gefitinib as first-line treatment in patients (pts) with stage IIIB-IV NSCLC harboring an activating EGFR mutation. Methods: Treatment-naïve stage IIIB or IV NSCLC pts with EGFR 19 Del or 21 L858R mutation are enrolled. Other inclusion criteria include ECOG PS of 0 or 1, ≥1 measurable lesion according to RECIST v1.1 and adequate organ function. Eligible pts will be randomized in a 1:1 ratio to receive either Apatinib or Placebo 500 mg QD plus Gefitinib 250 mg QD until progressive disease or unacceptable toxicity. Stratified randomization is based on EGFR mutation status, gender and ECOG PS. The primary endpoint is PFS. Secondary endpoints include overall survival, objective response rate, disease control rate, time to progression, duration of response, quality of life and the safety profile. Independent Data Monitoring Committee and Independent Review Committee will be used in this study. According to previous report (erlotinib plus bevacizumab vs. erlotinib alone: 16.0 vs. 9.7 mos, HR 0.54, Lancet Oncol, 15(11):1236-1244), it was assumed that the estimated median PFS would be 15 mos in the Apatinib + Gefitinib group and 10 mos in the Placebo + Gefitinib group. To detect a 5-mos improvement of PFS in Apatinib + Gefitinib group at a two-sided significant level of 0.05 and a power of 0.8, allowing for a dropout rate of 20%, the sample size should be 155 patients per group. In total, 310 patients will be enrolled in this trial at 30 sites in China. From August 2017, 100 patients have been enrolled. Clinical trial information: NCT02824458." @default.
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• W2891737590 date "2018-05-20" @default.
• W2891737590 modified "2023-09-25" @default.
• W2891737590 title "A multicenter, randomized, double-blind, placebo-controlled phase III study of apatinib or placebo plus gefitinib as first-line treatment in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC)." @default.
• W2891737590 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.tps9116" @default.
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