IFCT-1003 LADIE trial: Randomized phase II trial evaluating treatment with EGFR-TKI versus EGFR-TKI associated with anti-estrogen in women with non-squamous advanced stage NSCLC.

TPS8110 Background: The incidence of lung cancer is increasing dramatically in women and displays some specific epidemiological, radiological, clinical and pathological characteristics. Two main mechanisms emerged from recent findings in the field of lung carcinogenesis in women: the preferential involvement of the EGFR pathway and the potential impact of hormonal factors. The interaction of estrogen receptors with growth factor receptor signalling has also been shown. Preclinical data have shown that the combination of an EGFR-Tyrosine Kinase Inhibitor (TKI) with an anti-estrogen could overcome resistance to EGFR-TKI by postponing the reactivation of the PI3K-AKT pathway through the estrogen-mediated non-genomic pathway. Methods: We launched an open-label phase II randomized trial dedicated to women with advanced stage adenocarcinoma. Patients are treated by gefitinib (250 mg/d) vs. gefitinib + fulvestrant 500 mg MI / month (with a supplementary dose at day 15) in the EGFR mutated group (EGFR +) in first...