We conducted a multicenter single-arm phase II study to assess the efficacy and safety of neoadjuvant therapy with ceritinib followed by surgery in patients with ALK-positive resectable locally advanced (LA) NSCLC.Three cycles of ceritinib were administered as induction therapy. The drug was administered orally at the dose 750 mg once daily for 28 days per cycle. The primary endpoint was the major pathological response rate (mpRR). This study required 19 patients, with mpRR of 15% considered non-promising and 45% promising (one-side alpha = 0.025; beta = 0.2). Biomarker analyses using pre- and post-ceritinib through next-generation sequencing (NGS) of plasma and tissue is also planned. (Trial Identifier, UMIN000017906). Our results showed that neoadjuvant ceritinib is safe and effective, with a high rate of pathologic response, in patients with ALK-positive resectable LA-NSCLC, although the limitation of the data interpretation due to small sample size. READ ARTICLE
Journal of Thoracic Oncology DOI:10.1016/J.JTHO.2019.08.1320
Authors: Y. Zenke, K. Yoh, J. Sakakibara-Konishi, H. Daga, Y. Hosomi, N. Nogami, I. Okamoto, S. Matsumoto, S. Kuroda, M. Wakabayashi, S. Nomura, G. Ishii, A. Sato, M. Tsuboi, K. Goto
