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

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

Official Title
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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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: HM61713


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olmutinib, Epidermal Growth Factor Receptor mutation positive NSCLC, HM61713