Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI

A Single-arm, Open-label, Phase 1b Study Evaluating the Efficacy and Safety of Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI

The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD 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 1b study to evaluate the efficacy and safety of oral single agent olmutinib administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI.

Inclusion Criteria:

• Provide written informed consent before any study-specific procedures (including special Screening tests) are performed.
• At least 20 years of age at the time of signing informed consent.
• 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 with or without at least one line of chemotherapy.
• 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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Females of child-bearing potential (not surgically sterilized and between menarche and one-year post-menopause) must agree to use adequate contraception (one of the following listed below) during the study (both men and women as appropriate) 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 i.e. condoms.
• Recovery to ≤ Grade 1 or baseline of any toxicities due to prior treatments, 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 (including erlotinib, gefitinib, and afatinib) within 8 days or 5-fold half-life, whichever is the longer, of the first administration of study drug.
• 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 interstitial lung disease (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.