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