olmutinib 600 mg qd in patients with t790m-positive nsclc after treatment with an egfr-tki

Conditions: Non Small Cell Lung Cancer

Summary: 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.

Eligibility criteria:
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.