Non Small Cell Lung CancerPhase 2NCT02444819
Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy
A Phase 2 study testing HM61713 in people with Non Small Cell Lung Cancer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HM61713
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the detailed description
HM-EMSI-201 study targets NSCLC patients with EGFR mutations by HM61713 anticancer drug as the first-line therapy.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HM61713
- Keywords
- HM61713, Epidermal Growth Factor Receptor mutation positive NSCLC, olmutinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM61713Drug
Also called Olmutinib
HM61713 will be administered to evaluate efficacy and safety of subjects.
| Study group | Role | What they receive |
|---|---|---|
| HM61713 | Experimental | Subjects who entered the study will be administered HM61713 800 mg per day. Receives: Drug: HM61713 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
Measured: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Secondary outcomes (6)
Progression-free survival
To obtain a assessment of anti-tumor activity of HM61713 by evaluation of tumor response using RECIST version 1.1
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year
Quality of life questionnaire
Measured: At baseline and every visit, expected average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yohan Kim, MD, Study director, Hanmi Pharmaceutical Company LimitedKeunchil Park, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444819
- Sponsor's protocol ID
- HM-EMSI-201
- Status last verified
- Apr 2018
- First submitted
- 12 May 2015
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02444819
- Acronym / sponsor ID
- HM-EMSI-201
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- HM61713, Epidermal Growth Factor Receptor mutation positive NSCLC, olmutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM61713 | Experimental | Drug: HM61713Subjects who entered the study will be administered HM61713 800 mg per day. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM61713Also: OlmutinibHM61713 will be administered to evaluate efficacy and safety of subjects. | Drug | HM61713 |
Primary outcome
Objective response rate
Time frame: 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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yohan Kim, MD study director
Hanmi Pharmaceutical Company Limited
Keunchil Park, MD PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HM61713 in people with Non Small Cell Lung Cancer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: At baseline and every 6 weeks until disease progression or withdrawal from study, expected average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.