A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR mutation

HM-EMSI-201 study targets NSCLC patients with EGFR mutations by HM61713 anticancer drug as the first-line therapy.

Inclusion Criteria:

• Aged at least 19 years at the time of signing informed consent
• Cytologically or histologically confirmed, advanced or metastatic NSCLC which is not amenable to curative surgery (Stage IIIb or IV)
• Documented EGFR mutations (excluding exon 20 insertion)
• At least one lesion that can be used as a measurable lesion per RECIST version 1.1
• Performance status under 1 per ECOG score
• Life expectancy of at least 12 weeks
• Adequate hematological and biological functions
• Provide voluntary consent to participate the study and sign the written consent form

Exclusion Criteria:

• Treatment of chemotherapy, biological therapy or immunotherapy for anticancer therapies of stage IIIb or IV NSCLC (excluding adjuvant/neoadjuvant chemotherapy, radiotherapy or radiochemotherapy prior to more than 6 months from the first dose of study treatment
• History of treatment with an EGFR targeting small molecule or antibodies
• Any non-study related significant surgical procedures requires general anesthesia or breathing apparatus within the past 4 weeks of the first dose of study treatment (excluding video-assisted thoracoscopic surgery or open-and-closed surgery prior to the past 2 weeks of the first dose of study treatment)
• History of any other malignancy within 5 years of study participation (other than curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors unless it has been definitively treated with no evidence of relapse or recurrence within the past 3 years)
• Clinically significant uncontrolled conditions of infectious disease including active infection that requires parenteral antibiotics (except when conditions are definitively treated or controlled)
• Spinal cord compression, leptomeningeal carcinomatosis, symptomatic or uncontrolled brain metastasis
• Presence or history of ILD or pulmonary fibrosis
• NYHA class III or IV cardiac insufficiency, uncontrolled hypertension, experienced unstable angina pectoris or cardiac infarction within 6 months, uncontrolled cardiac arrhythmia or clinically significant abnormal cardiovascular activities
• LVEF < 40%
• Presence or history of pancreatitis or serum amylase > 1.5xULN
• Inability to swallow the formulated product or gastrointestinal tract abnormalities which would preclude administration or absorption of study medication
• Mental or congenital disabilities (e.g. dementia or epilepsy) which would preclude understanding of informed consent or following the study protocol
• History of hypersensitivities to investigational drug or related similar class drugs
• Pregnant or breast feeding
• Unwillingness of adequate contraception during study treatment and at least 2 months after treatment
• Unwillingness of following procedures of study protocol or follow-up assessments; Unable to follow up for long term for psychological, social, family problem or geographical reasons
• History of treatment with other investigational drugs or investigational medical devices prior to 28 days of the first dose of study treatment
• In the opinion of the investigator, the patient is an unsuitable candidate to the study
• ECG finding of QTcF > 450 msec at rest