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

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

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: HM61713

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM61713; Subjects who entered the study will be administered HM61713 800 mg per day.	Drug: HM61713; HM61713 will be administered to evaluate efficacy and safety of subjects.; Other Names: Olmutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1	At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1	At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Disease control rate	To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1	At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
overall survival	To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1	At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Time to progression	To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1	At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Maximum decrease in tumor size	To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1	At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Quality of life questionnaire		At baseline and every visit, expected average 1 year

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Study Director: Yohan Kim, MD, Hanmi Pharmaceutical Company Limited; Principal Investigator: Keunchil Park, MD PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: HM61713; olmutinib; Epidermal Growth Factor Receptor mutation positive NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: HM-EMSI-201