Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI

Inclusion Criteria: * Provide written informed consent before any study-specific procedures (including special Screening tests) are performed. * At least 20 years of age at the time of signing informed consent. * Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy. * Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI with or without at least one line of chemotherapy. * At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q). * World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months. * Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen. * At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) and for 3 months after the last dose of study drug. * Male patients should be documented to be sterile or agree to use barrier contraception i.e. condoms. * Recovery to ≤ Grade 1 or baseline of any toxicities due to prior treatments, except for stable sensory neuropathy ≤ Grade 2 and alopecia. Exclusion Criteria: * Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713 * Previous treatment with anticancer therapies, EGFR-TKI (including erlotinib, gefitinib, and afatinib) within 8 days or 5-fold half-life, whichever is the longer, of the first administration of study drug. * Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug * Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases * History of any other malignancy * Clinically significant uncontrolled condition(s) * Active or chronic pancreatitis * Anyone with cardiac abnormalities or history * Presence or history of interstitial lung disease (ILD), drug-induced ILD, or presence of radiation pneumonitis. * Pregnant or breast feeding. * In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713.