ABSTRACT Aim: Anaplastic lymphoma kinase (ALK) positive NSCLC identifies a unique subset of patients who respond to treatment with crizotinib (Pfizer Inc, NY), an ALK receptor tyrosine kinase inhibitor. However, it is not well established whether ALK status is predictive of a better or a worse outcome for those who do not receive crizotinib. We performed a systematic review of recent literature on ALK positive NSCLC to answer this question. Methods: Ovid Medline and Embase databases were searched for publications on ALK-positive NSCLC until December 2013. Studies were included if outcomes for crizotinib naive patients were presented for either Progression-Free Survival (PFS) or Overall Survival (OS). For each study identified, 2 investigators independently extracted and tabulated relevant findings. Demographics, ALK status, type of diagnostic test, treatment received and response to treatment were noted. To determine if ALK status was prognostic, efficacy outcomes (PFS and / or OS) for ALK-positive patients were compared to ALK wild type (WT) patients. Results: Twenty one studies published between 2009 to 2013, with nearly 8000 screened NSCLC patients and 700 ALK-positive patients, met the selection criteria. All publications were retrospective in nature, majority reported single institution experiences, with a mix of completely resected early stage NSCLC and recurrent or advanced disease. The number of ALK-positive patients in studies determined by Fluorescent In Situ Hybridisation (FISH) ranged from 7 to 121 (mean = 32) and the number of ALK-positive patients in studies determined by non-FISH methods ranged from 3 - 39 (mean = 18). Enrichment strategies were commonly employed with predominantly adenocarcinomas being selected for ALK testing. PFS and / or OS for ALK-positive NSCLC patients did not demonstrate a favourable outcome and was similar or worse compared to EGFR WT/ ALK WT patients. Conclusions: This analysis of published retrospective studies in ALK-positive NSCLC, suggest that ALK-positivity is not a positive prognostic factor and does not confer a favourable outcome in absence of crizotinib therapy. Disclosure: J. Binko: Employee of Pfizer Oncology and holder of Pfizer stock; P. Delahoy: Employee of Pfizer Oncology and holder of Pfizer stock. M. Alam: Employee of Pfizer Oncology and holder of Pfizer stock.