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

A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

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