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Metastatic Non-small Cell Lung CancerPhase 2NCT03300115

Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC

A Phase 2 study testing AC0010 in people with Metastatic Non-small Cell Lung Cancer, run by Hangzhou ACEA Pharmaceutical Research Co., Ltd. at 25 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Non-small Cell Lung Cancer
What is being tested?
AC0010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
25 sitesChina
Study dates
18 May 2017to 17 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-75 years (including 18 and 75 years old).
  • Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent non-small cell lung cancer which cannot receive radical surgery and radiotherapy.
  • The patient has at least one radio graphically (CT, MRI)measurable lesion according to the RECIST criteria for solid tumor response; long-diameter of tumor scanned by CT\&MRI ≥10mm, or short-diameter of metastatic cervical lymph nodes≥15mm. With no radiotherapy and biopsy.
  • Patients without CNS metastases or asymptomatic patients with brain metastases. The number of CNS metastases focus≤2, maximum diameter <10mm.
  • Document prove EGFR mutation before treatment of EGFR TKI, or show clinical benefit after treatment of EGFR TKI (PR, CR evaluation according to RECIST or more than half-year SD duration); tumor tissue proved to be EGFR T790M positive mutation by center lab after last treatment.
  • Patients need to undergo biopsy of primary or metastatic tumor tissue and provide pathological sections to site's central lab; otherwise, the patients need to undergo biopsy of primary or metastatic tumor tissue in the screening period and provide pathological sections to the site's central laboratory.
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  • Patients who have previously received first-generation EGFR-TKI (erlotinib, gefitinib, ectectin) treatment and developed resistance and are only allowed to have received one chemotherapy regimen (maintenance treatment with the same drug is allowed; but maintenance treatment with a different drug is not allowed), or are positive for primary T790M mutation but have not received treatment or have only received first-line treatment.
  • The patient must have good organ function, including meeting the laboratory test requirements at screening.
  • Patients must recover to ≤Grade 1 (CTCAE v4.03)toxicity from the previous treatment (patients with any grade of hair loss are allowed to enter the study).
  • ECOG score: 0-1 points. No deterioration in the last 2 weeks.
  • Expected survival time:> 12 weeks.
  • Patients who can cooperate with the observation of adverse events and efficacy.
  • Patients or their legal representatives have signed a written informed consent form.

Who cannot join

  • Acute hepatitis C, chronic hepatitis C and active hepatitis B (positive HBsAg; HBcAb or HBeAb positive and HBV DNA positive).
  • HIV antibody positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
  • A past history of interstitial lung disease and radiation pneumonia.
  • Clinically significant abnormalities of resting ECG in rhythm, conduction and morphology, such as complete left bundle branch block, Grade II and above heart block, PR interval> 250 ms, or myocardial infarction within the past 6 months; there are risk factors leading to prolongation of QTc interval or increasing arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or medical history of sudden death at an age of < 40 years among the patient's first-degree relatives, and 12-lead ECG QT interval correction Fridericia method (QTcF interval)> 450 ms for male, >470ms for female.
  • The investigator judges based on safety concerns or clinical study process that the patient had any other condition that is prohibited for participation in the clinical study, such as severe infection/inflammation, intestinal obstruction, inability to swallow medication, social/psychological problems, etc.
  • With clinically significant electrolyte abnormalities in laboratory tests;
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  • In addition to NSCLC, patients who have been diagnosed with another and/or treatment-requiring malignant disease in recent 5 years (this exclusion criterion does not include the following circumstances: completely resected basal cell and squamous cell skin cancer, inert malignant tumor currently requiring no treatment, and any type of completely resected carcinoma in situ).
  • Patients who have used high-dose glucocorticoids or other immunosuppressive agents within 1 month prior to screening.
  • Interval time between previous EGFR TKI treatment and AC0010 <8 days or 5 half-time, subject to the long time; Interval time between major surgery /radiotherapy and AC0010 <4 weeks; Patients who are using any drug known to prolong QT interval or known potent CYP3A4 enzyme inducer or inhibitor within 4 weeks before the first dose.
  • Patients who have used high-dose glucocorticoids or other immunosuppressive agents within 1 month prior to screening.
  • Patients who have previously administered third-generation EGFR-TKI drugs (e.g.,AZD9291, Avitinib, CO-1686, HM61713, etc.).
  • Patients who have been registered and received the study treatment or withdrawn from the study cannot be enrolled.
  • Pregnant or lactating women.
  • Women with childbearing potential are defined as all women who are physiologically able to have a pregnancy, unless they are using an efficient contraceptive method during treatment and within 7 days after discontinuation of treatment.
  • Patients who are considered by the investigator as inappropriate to participate in the study.

Trial locations and contacts

25 sites in 1 country.

Wanhong Xu, PhD contact

+8657128908600

kayla.liu@aceapharma.com

25 sites in 1 country

China25 sites, 25 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

    Jian Fang

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

    Junling Li

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

    Zhefeng Liu

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Ying Cheng

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    Jiuwei Cui

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Peiguo Cao

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Chengping Hu

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

    Zongan Liang

    Zongan Liang

    Recruiting

  • Daping Hospital,Research Institute of Surgery Third Military Medical University

    Chongqing, Chongqing Municipality, 400000

    Yong He

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

    Cheng Huang

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Yilong Wu

    Recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310000

    Limin Wang

    Recruiting

  • Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Hongming Pan

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Jianjin Huang

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Yiping Zhang

    Yun Fan

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250000

    Zhehai Wang

    Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530000

    Guosheng Feng

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

    Jian'an Huang

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

    Changli Wang

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300000

    Jun Chen

    Recruiting

  • Tongji Medical College of HUST

    Wuhan, Hubei, 430000

    Yuan Chen

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Conghua Xie

    Recruiting

  • Tangdu Hospital

    Xi’an, Shanxi, 710000

    Helong Zhang

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

    Buhai Wang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Yanqiu Zhao

    Recruiting

Other trials in China

About this study

Official title: Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety.

Read the detailed description

The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety with overall objective tumor response rate (ORR) as the primary efficacy evaluation indicator, and further evaluate subjects' duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and quality of life (QoL). Safety indicators of subjects are further evaluated through adverse events, vital signs and clinical laboratory parameters.

Being tested
AC0010
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.

  • AC0010Drug

    Also called AC0010MA

    After subjects prove eligible after screening and are enrolled, they are given AC0010 300 mg Bid (the two doses are advised to be administered at an interval of 12 hours), receive evaluation of safety indicators every 3 weeks, efficacy evaluation every 6 weeks until disease progression or intolerable toxicities or withdrawal from the trial. (If the investigator suspects disease progression, CT or MRI may be performed in advance; if the patient does not have disease progression, subsequent efficacy evaluation will proceed still according to the protocol).

Study groups in NCT03300115
Study groupRoleWhat they receive
AC0010ExperimentalEach participant will be given AC0010 300mg bid.
Receives: Drug: AC0010

What is being measured

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

  1. ORR(Objective Response Rate)

    To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary outcomes (5)

  1. DoR (Duration of Response)

    To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

  2. PFS (Progression-free survival)

    To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

  3. DCR (Disease control rate)

    To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

  4. OS (Overall survival)

    To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

  5. The lung cancer symptoms and health-related quality of life (HRQoL)

    To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

    Measured: Every 3 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Timeline

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

  1. First posted3 Oct 2017
  2. Study start18 May 2017
  3. Primary completion17 Jun 2019 (estimated)
  4. Study completion17 Dec 2020 (estimated)

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
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03300115
Sponsor's protocol ID
AC201602AVTN03
Status last verified
Feb 2019
First submitted
27 Sep 2017
Last updated
19 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AC0010 in people with Metastatic Non-small Cell Lung Cancer, run by Hangzhou ACEA Pharmaceutical Research Co., Ltd. at 25 sites in China.

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 13 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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wanhong Xu, PhD (+8657128908600, kayla.liu@aceapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR(Objective Response Rate) (time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, 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 NCT03300115.

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 19 Feb 2019.

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