Journal article

Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1-2 trial

Alice T Shaw, Benjamin J Solomon, Rita Chiari, Gregory J Riely, Benjamin Besse, Ross A Soo, Steven Kao, Chia-Chi Lin, Todd M Bauer, Jill S Clancy, Holger Thurm, Jean-Francois Martini, Gerson Peltz, Antonello Abbattista, Sherry Li, Sai-Hong Ignatius Ou

The Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2019

Abstract

BACKGROUND: Lorlatinib is a potent, brain-penetrant, third-generation tyrosine kinase inhibitor (TKI) that targets ALK and ROS1 with preclinical activity against most known resistance mutations in ALK and ROS1. We investigated the antitumour activity and safety of lorlatinib in advanced, ROS1-positive non-small-cell lung cancer (NSCLC). METHODS: In this open-label, single-arm, phase 1-2 trial, we enrolled patients (aged ≥18 years) with histologically or cytologically confirmed advanced ROS1-positive NSCLC, with or without CNS metastases, with an Eastern Cooperative Oncology Group performance status of 2 or less (≤1 for phase 1 only) from 28 hospitals in 12 countries worldwide. Lorlatinib 100..

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