Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment hm61713 (bi 1482694)
Phase phase 2
Target EGFR
Sponsor Hanmi Pharmaceutical Company Limited
Collaborator Boehringer Ingelheim
Start date March 2015
End date December 2016
Trial size 35 participants
Trial identifier NCT02444819, HM-EMSI-201

Summary

A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of HM61713 (BI 1482694) as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR mutation

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects who entered the study will be administered HM61713 800 mg per day.
hm61713 (bi 1482694) Olmutinib
HM61713 will be administered to evaluate efficacy and safety of subjects.

Primary Outcomes

Measure
Objective response rate
time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

Secondary Outcomes

Measure
Progression-free survival
time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Disease control rate
time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
overall survival
time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Time to progression
time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Maximum decrease in tumor size
time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Quality of life questionnaire
time frame: At baseline and every visit, expected average 1 year

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title A Multicenter, Single-arm, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of HM61713 (BI 1482694) as the 1st-line Anticancer Agent in NSCLC Patients With EGFR Mutation
Principal investigator Keunchil Park, MD PhD
Description HM-EMSI-201 study targets NSCLC patients with EGFR mutations by HM61713 (BI 1482694) anticancer drug as the first-line therapy.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited.