Non Small Cell Lung CancerPhase 2NCT02485652
Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung
A Phase 2 study testing HM61713 in people with Non Small Cell Lung Cancer, run by Hanmi Pharmaceutical Company Limited at 72 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HM61713
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 72 sitesin 10 countries
- Study dates
- 31 Aug 2015to 8 Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: at least 20 years of age
- Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
- Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
- At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
- World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
- Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
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- At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
- Adequate hematological and biological function
- Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
- Male patients should be documented to be sterile or agree to use barrier contraception
- Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia
Who cannot join
- Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
- Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
- Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
- Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
- History of any other malignancy
- Clinically significant uncontrolled condition(s)
Show all 11Show fewer
- Active or chronic pancreatitis
- Anyone with cardiac abnormalities or history
- Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
- Pregnant or breast feeding
- In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713
Trial locations and contacts
72 sites in 10 countries.
72 sites in 10 countries
United States15 sites
Research Site
Bethesda, Maryland
Research Site
Beverly Hills, California
Research Site
Boca Raton, Florida
Research Site
Boston, Massachusetts
Research Site
Burbank, California
Research Site
Charlotte, North Carolina
Research Site
Evanston, Illinois
Research Site
Honolulu, Hawaii
Research Site
Lebanon, New Hampshire
Research Site 2
Los Angeles, California
Research Site
Los Angeles, California
Research Site
Montebello, California
Research Site
Orange, California
Research Site
San Diego, California
Research Site
Washington, Washington
South Korea14 sites
Research Site
Cheongju-si
Research Site
Goyang-si
Research Site
Hwasun
Research Site
Incheon
Research Site 2
Seongnam-si
Research Site
Seongnam-si
Research Site 2
Seoul
Research Site 3
Seoul
Research Site 4
Seoul
Research Site 5
Seoul
Research Site 6
Seoul
Research Site 7
Seoul
Research Site 8
Seoul
Research Site
Seoul
Spain11 sites
Research Site
A Coruña
Research Site 2
Barcelona
Research Site 3
Barcelona
Research Site 4
Barcelona
Research Site
Barcelona
Research Site
Donostia / San Sebastian
Research Site 2
Madrid
Research Site
Madrid
Research Site
Navarra
Research Site 2
Valencia
Research Site
Valencia
Australia6 sites
Research Site
Darlinghurst
Research site
Fitzroy
Research Site
Frankston
Research Site
Kogarah
Research Site
St Albans
Research Site
Woolloongabba
Taiwan6 sites
Research Site
Kaohsiung City
Research Site
Taichung
Research Site 2
Tainan
Research Site
Tainan
Research Site 2
Taipei
Research Site
Taipei
Germany5 sites
Research Site
Berlin
Research Site
Homburg
Research Site
Leipzig
Research Site
München
Research Site
Ulm
Italy5 sites
Research Site
Bergamo
Research Site
Bologna
Research Site
Catania
Research Site
Milan
Research Site
Rome
Philippines5 sites
Research Site
Cebu
Research Site
Makati, Kalakhang Maynila
Research Site 2
Manila, National Capital Region
Research Site
Manila, National Capital Region
Research Site
Pasig, Manila
Malaysia4 sites
Research Site
George Town, Pulau Pinang
Research Site
Kuala Lumpur
Research Site
Kuantan
Research Site
Kuching
About this study
Official title: A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).
Read the detailed description
This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HM61713
- Keywords
- NSCLC, EGFR-TKI, non small cell lung cancer, HM61713, T790M-positive, lung cancer, Phase II, Olmutinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM61713Drug
Also called Olmutinib
800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| HM61713 | Experimental | HM61713 800 mg (2 x 400 mg tablets) once daily (QD) Receives: Drug: HM61713 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).
Measured: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Secondary outcomes (13)
Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1
To assess clinical efficacy of HM61713 regarding disease control rate (DCR).
Measured: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death
To assess clinical efficacy of HM61713 regarding Duration of overall tumor response (DR).
Measured: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first
To assess clinical efficacy of HM61713 regarding Progression-free survival (PFS).
Measured: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Overall survival (OS), defined as the time from first administration of study drug until death from any cause
To assess clinical efficacy of HM61713 regarding Overall survival (OS).
Measured: From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1
To assess clinical efficacy of HM61713 regarding Time to progression (TTP).
Measured: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response
To assess clinical efficacy of HM61713 regarding tumor shrinkage.
Measured: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Peak concentration (Cmax) of HM61713
To determine the pharmacokinetic (PK) profile of HM61713.
Measured: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Trough plasma concentration (Ctrough) of HM61713
To determine the pharmacokinetic (PK) profile of HM61713.
Measured: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713
To determine the pharmacokinetic (PK) profile of HM61713.
Measured: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Patient reported outcomes (PROs)
To assess patient reported outcomes (PROs) of health-related quality of life (HRQoL), disease/treatment-related symptoms of lung cancer, and general health status.
Measured: At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
ECG/QTc (absolute values and change from baseline)
To evaluate the effect of HM61713 on the QT interval.
Measured: Adverse events will be collected from baseline until 28 days after the last dose
Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
To assess the safety and tolerability of HM61713.
Measured: Adverse events will be collected from baseline until 28 days after the last dose
QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS.
To assess the safety and tolerability of HM61713.
Measured: Adverse events will be collected from baseline until 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start31 Aug 2015
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Why it stopped: Study termination by the Sponsor
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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keunchil Park, M.D., Ph.D, Principal investigator, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of KoreaPasi A. Jänne, M.D., Ph.D, Principal investigator, Dana-Farber Cancer Institute, Boston, MA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485652
- Sponsor's protocol ID
- HM-EMSI-202
- Other IDs
- 2015-001435-21, 2015
- Status last verified
- Jan 2021
- First submitted
- 22 Jun 2015
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor
- ClinicalTrials.gov ID
- NCT02485652
- Acronym / sponsor ID
- HM-EMSI-202
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR-TKI, non small cell lung cancer, HM61713, T790M-positive, lung cancer, Phase II, Olmutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study termination by the Sponsor
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 30 Jun 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.
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).
Detailed description
This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).
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: HM61713HM61713 800 mg (2 x 400 mg tablets) once daily (QD) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: at least 20 years of age
- Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
- Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
- At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
- World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
Key exclusion criteria (11 listed)
- Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
- Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
- Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
- Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
- History of any other malignancy
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: Olmutinib800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigator"s opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria. | Drug | HM61713 |
Primary outcome
Objective response rate (ORR)
Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
To assess the anti-tumor efficacy of HM61713 as measured by objective response rate (ORR).
13 secondary outcomes
Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1
Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death
Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Progression-free survival (PFS), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first
Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Overall survival (OS), defined as the time from first administration of study drug until death from any cause
Time frame: From first dose to end of study or date of death from any cause whichever came first, assessed up to 48 months
Time to progression (TTP), defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1
Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Tumor shrinkage calculated as absolute change and percentage change from baseline in sum of tumor size at each assessment using RECIST tumor response
Time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months
Peak concentration (Cmax) of HM61713
Time frame: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Trough plasma concentration (Ctrough) of HM61713
Time frame: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Area under the plasma concentration time curve over the 24-hour dosing interval (AUC) of HM61713
Time frame: Pre-dose (-30 to 0 mins) and 1 hour (± 5 mins), 3, 4, 6 hours (± 10 mins) on Day 1 and Day 15 of Cycle 1 and pre-dose (-30 to 0 mins) only on Day 8 of Cycle 1 and Day 1 of Cycle 2 (Day 22)
Patient reported outcomes (PROs)
Time frame: At baseline and every 6 weeks from time of discontinuation, assessed up to 24 months
ECG/QTc (absolute values and change from baseline)
Time frame: Adverse events will be collected from baseline until 28 days after the last dose
Incidence of reported AEs and abnormal laboratory tests (AEs will be assessed using the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4).
Time frame: Adverse events will be collected from baseline until 28 days after the last dose
QTc interval as assessed by digital ECG with central reading. The QT interval will be rate-corrected using 3 methods: QTcF, QTcB and QTcS.
Time frame: Adverse events will be collected from baseline until 28 days after the last dose
Results and safety
The study was stopped early (reason given: Study termination by the Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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.
Keunchil Park, M.D., Ph.D principal investigator
Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
Pasi A. Jänne, M.D., Ph.D principal investigator
Dana-Farber Cancer Institute, Boston, MA, USA
72 sites in 10 countries: 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 72 sites in 10 countries.
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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, South Korea, Spain, Australia, Taiwan and 5 more countries. 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 was stopped early (reason given: Study termination by the Sponsor). Results are not available in the source record.
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 (ORR) (time frame: At baseline and every 6 weeks from time of first dose until date of progression, assessed up to 12 months). 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 22 Jan 2021.