Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

Inclusion Criteria: * Age: at least 20 years of age * 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 * 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 RECIST version 1.1 * Adequate hematological and biological function * Females of child-bearing potential must agree to use adequate contraception 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 * Recovery to ≤ Grade 1 or baseline of any toxicities, 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, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy * 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 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