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