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Non Small Cell Lung CancerPhase 2NCT03228277

Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA

A Phase 2 study testing Olmutinib in people with Non Small Cell Lung Cancer, run by Konkuk University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from extracellular vesicles of bronchoalveolar lavage fluid. 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?
Olmutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSouth Korea
Study dates
17 Jul 2017to 31 Jul 2019
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

  • Male or female, aged at least 19 years
  • Obtained written informed consent
  • Histologically- or cytologically confirmed diagnosis of unresectable Stage IIIB or IV non-small cell lung cancer.
  • Confirmation that the tumor harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Prior treatment with at least one line of a single agent EGFR TKI (gefitinib, erlotinib, afatinib) and confirmed progressive disease after treatment with EGFR TKI
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  • Regardless of treatment sequence between previous chemotherapy and EGFR TKI
  • Regardless of whether they were administered conventional chemotherapy, if therapy were treated with at least one EGFR TKI
  • Subjects who will undergo bronchoscopy/ BAL procedures and sufficient amount of BAL fluid is carefully collected for EGFR mutation analysis.
  • Confirmation that the extracellular vesicles (EV) extracted from bronchoalveolar lavage fluid (BALF) harbour T790M mutation (It can be replaced previous the same result throughout the follow up period before enrollment.)
  • At least one measurable disease (except brain) at baseline according to RECIST version 1.1
  • Female subjects must be postmenopausal (for at least one year), or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative urinary β-hCG pregnancy test at screening.
  • Male subjects should be willing to use barrier methods which are suitable for sexual partner throughout the study.
  • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. The subject also must sign and date the consent form before specific procedures or sampling.
  • Adequate organ function as defined by liver, kidney, and hematologic laboratory testing as below
  • Absolute neutrophil count (ANC) ≥ 1500/mm3, Platelet ≥ 100,000 /mm3 Hemoglobin (Hb) ≥ 9.0g/dL
  • Serum creatinine ≤ upper limit of normal (ULN)
  • AST/ALT/ALP ≤ 3 times ULN, Total bilirubin ≤2.0 mg/dL AST/ALT/ALP ≤ 5 times ULN in patients with metastatic lesions to the liver ALP ≤ 5 times ULN in patients with metastatic lesions to the bone
  • Expected survival of at least 12 weeks

Who cannot join

  • Previous treatment with anticancer therapies, EGFR-TKI, olmutinib (HM61713), or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, Osimertinib (AZD9291), Rociletinib (CO-1686), investigational agent(s) within 30 days prior to the first administration of study drug, radiotherapy
  • Treatment with a potent cytochrome P450 (CYP) 3A4 inhibitors or inducers
  • History of any other malignancy EXCEPTIONS are:
  • adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, thyroid cancer
  • other malignancies diagnosed prior to randomisation and treated with no evidence of disease recurrence more than 3 years
  • Any history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of III or IV, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to enrolment. Increased QTc interval > 450 ms on screening ECG
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  • Any history of presence of interstitial lung disease
  • Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption).
  • Ongoing active infection with, hepatitis B virus (infection defined as a positive HbsAg and/ or HBV DNA), hepatitis C virus (infection defined as a positive HCV RNA), or human immunodeficiency virus (HIV) Type 1/2 infection at the time of screening.
  • Known history of hypersensitivity to active or inactive excipients of study drug (olmutinib) or drugs with a similar chemical structure of olmutinib
  • Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Symptomatic or uncontrolled central nervous system (CNS) metastases (Patients are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically and radiologically stable)
  • Uncontrolled active infectious disease (with the exception of those that are considered to be needed topical antibiotics, however subjects can be enrolled into the study after they complete their treatment)
  • Unable to attend all the study visits or comply with study procedures
  • Patients who had received other investigational product within 30 days prior to the first administration of study drug except for gefitinib, erlotinib, or afatinib

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Konkuk University Medical Center

    Seoul, 05030

Other trials in South Korea

About this study

Official title: Phase II, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy of Olmutinib(Olita®) in Patients With NSCLC Who Harboring T790M Mutation Confirmed Using DNA Extracted From Extracellular Vesicles in Bronchoalveolar Lavage Fluid

The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from extracellular vesicles of bronchoalveolar lavage fluid.

Read the detailed description

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of Olmutinib(Olita®) administered to patients with T790M-positive NSCLC confirmed using DNA extracted from extracellular vesicles in bronchoalveolar lavage fluid as measured by objective response rate (ORR).

Being tested
Olmutinib
Keywords
Extracellular vesicles, Bronchoalveolar lavage fluid, Liquid biopsy, T790M, NSCLC, Exosomes, EGFR mutation testing
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.

  • OlmutinibDrug

    Also called Olita®

    Patients to be provided with Olmutinib 800mg (2 x 400 mg tablets) once daily (QD)

Study groups in NCT03228277
Study groupRoleWhat they receive
OlmutinibExperimentalSingle arm of Olmutinib, staring dose of 800 mg
Receives: Drug: Olmutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    defined as the proportion of patients who achieved complete remission(CR) or partial remission(PR) based on RECIST version 1.1

    Measured: Change from baseline at every 6 weeks until disease progression or withdrawal from study, assessed up to 12 months

Secondary outcomes (2)

  1. 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

    Measured: Change from baseline at every 6 weeks until disease progression or withdrawal from study, assessed up to 12 months

  2. 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

    Measured: Change from baseline at every 6 weeks until disease progression or withdrawal from study, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start17 Jul 2017
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2019

Resources

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03228277
Sponsor's protocol ID
KASTT005_BAL_Olita
Status last verified
Aug 2019
First submitted
17 Jul 2017
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olmutinib in people with Non Small Cell Lung Cancer, run by Konkuk University Medical Center 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 19 inclusion and 15 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 28 Aug 2019. 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 (ORR) (time frame: Change from baseline at every 6 weeks until disease progression or withdrawal from study, 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?

On the ClinicalTrials.gov record for NCT03228277.

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 28 Aug 2019.

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