Clinical trial NCT02444819: Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy
Official title: A Multicenter, Single-arm, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line Anticancer Agent in NSCLC Patients With EGFR Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: HM61713
Epidermal Growth Factor Receptor mutation positive NSCLC
olmutinib
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
measure: Disease control rate
timeFrame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
measure: overall survival
timeFrame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
measure: Time to progression
timeFrame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
measure: Maximum decrease in tumor size
timeFrame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
measure: Quality of life questionnaire
timeFrame: At baseline and every visit, expected average 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Hanmi Pharmaceutical Company Limited
name: Yohan Kim, MD
role: STUDY_DIRECTOR
affiliation: Samsung Medical Center
name: Keunchil Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: