Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy
- Registration Number
- NCT02444819
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
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
- Detailed Description
HM-EMSI-201 study targets NSCLC patients with EGFR mutations by HM61713 anticancer drug as the first-line therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HM61713 HM61713 Subjects who entered the study will be administered HM61713 800 mg per day.
- Primary Outcome Measures
Name Time Method Objective response rate At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
- Secondary Outcome Measures
Name Time Method Progression-free survival At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
Time to progression At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
Disease control rate At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
Quality of life questionnaire At baseline and every visit, expected average 1 year overall survival At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
Maximum decrease in tumor size At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1