O3. Registry study in NSCLC patients with EGFR, ALK, or ROS1 mutations

Abstract: The discovery of activating epidermal growth factor receptor (EGFR) mutations and chromosomal rearrangements involving the anaplastic lymphoma kinase (ALK) gene or the ROS1 gene has improved the treatment in patients with advanced non-small cell lung cancer (NSCLC). Activating EGFR mutations occur in about 10% of lung adenocarcinomas and are associated with high response rates and longer progression-free survival (PFS) to EGFR TKIs. ALK rearrangements are observed in 3-5% and ROS1 rearrangements in 1-2% of lung adenocarcinomas. ALK inhibitors have been shown to be particularly effective in these patients. In order to obtain more data on patients harboring EGFR, ALK, or ROS1 mutations in their tumors, a registry study will be performed. This registry is planned for 3 years and will be a multicentre, observational registry study. Approximately 15 sites in Austria will participate in this registry. It is expected that about 180 cases per year will be documented and, therefore, the total number of patients will be about 540. The objectives of the study are: (I) to evaluate the distribution of EGFR, ALK, or ROS1 mutations; (II) detection methods used in clinical routine and frequency of mutation testing; (III) to gather more data on treatment (first-line, second-line, later lines) including outcome of patients harboring these mutations in their tumors; (IV) re-biopsy at the time of disease progression in routine practice particularly in patients treated with molecular targeted therapy will be assessed; (V) mutations or genetic alterations at the time of relapse and the treatment of patients refractory to first-line EGFR TKI or ALK inhibitor treatment will be studied; (VI) treatment of patients at the time of disease progression; (VII) virtual tumor bank (decentralized stored material).

Keywords: Non-small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR); ALK; ROS1; mutation