Chunlei Shi¹, Meng-zhao Wang², Yong He³, Yi-ping Zhang⁴, Sergei Tjulandin⁵, MarianneRatcliffe⁶, Rose Mccormack⁶, Baohui Han

¹Department ofRespiratory Medicine, Shanghai Chest Hospital, Jiao Tong University, Shanghai,China, ²Department ofRespiratory Medicine, Peking union   Medical College Hospital, Peking union  Medical College and Chinese Academy of Medical Sciences, Beijing, China, ³Department ofRespiratory Medicine, Daping Hospital, The Third Military Medical University,Chongquing, China, ⁴Department ofChemotherapy, Zhejiang Cancer Hospital and Key Laboratory Diagnosis andTreatment Technology on Thoracic Oncology, Hangzhou, China, ⁵Department of ClinicalPharmacology and Chemotherapy, Russian Cancer Research Center, Moscow,Russia, ⁶AstraZeneca,Macclesfield, UK

Objective:IGNITE (a large, multinational,diagnostic, non-comparative, interventional study; NCT01788163) assessed EGFRmutation frequency in patients with advanced NSCLC of adenocarcinoma(ADC)/non-ADC histology in Chinese patients. Method: Eligible patients:local/metastatic a NSCLC (chemotherapy-naïve, newly diagnosed/recurrent diseaseafter resection) from 26 centres in China; Primary endpoint: EGFR mutationfrequency by histology (locally tested). Secondary endpoints: EGFR mutationstatus concordance between matched tissue/cytology and plasma (circulating-freetumour-derived cf-DNA) samples; correlation between mutation status anddemographic/disease status; treatment decisions; EGFR testing practices. Result:1458 pts enrolled; tissue/cytology evaluable: 1391; plasma evaluable: 1421.Tissue/cytology EGFR mutation frequency (China): ADC: 51.3%; non-ADC: 11.1%;plasma generally lower. Mutation status concordance in 1355 matched samples:77.6% (95%CI 75.2–79.8); test sensitivity: 48.7% (44.5–53.0); specificity:97.1% (95.8–98.2); positive predictive value (PPV): 92.1% (88.3–94.9); negativePV: 73.6% (70.9–76.2). PPV in 606 samples tested with identical highlysensitive methods: 94.3%. Mutation frequency significantly correlated with:ADC; never-smokers; greater number of metastatic organs; females(tissue/cytology only); age ≥65 years (plasma only). Conclusion: TheIGNITE study further confirms that adenocarcinoma histology, never-smokingstatus and Asian ethnicity are significantly correlated with EGFRmutation-positive status. Plasma ctDNA may be used for patients where a tumoursample is not available/evaluable to determine EGFR mutation status. EGFRmutation status and histology data indicate that EGFR mutation testing shouldbe considered in patients with NSCLC of adenocarcinoma and non-adenocarcinomahistology.

Key Words: non-small-cell lung cancer