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

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral
single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with
an EGFR-TKI as measured by objective response rate (ORR).

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