Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy

Hanmi Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: HM61713

Study type

Interventional

Funder types

Industry

Identifiers

NCT02444819

HM-EMSI-201

Details and patient eligibility

About

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

Full description

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

Enrollment

33 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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