Clinical Trials /

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

NCT03300115

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: AC201602AVTN03
  • NCT ID: NCT03300115

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
AC0010AC0010MAAC0010

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
AC0010ExperimentalEach participant will be given AC0010 300mg bid.
  • AC0010

Eligibility Criteria

        Inclusion Criteria:

          1. Aged 18-75 years (including 18 and 75 years old).

          2. Histologically or cytologically confirmed metastatic or unresectable locally advanced,
             recurrent non-small cell lung cancer which cannot receive radical surgery and
             radiotherapy.

          3. 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.

          4. Patients without CNS metastases or asymptomatic patients with brain metastases. The
             number of CNS metastases focus≤2, maximum diameter <10mm.

          5. 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.

          6. 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.

          7. 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.

          8. The patient must have good organ function, including meeting the laboratory test
             requirements at screening.

          9. 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).

         10. ECOG score: 0-1 points. No deterioration in the last 2 weeks.

         11. Expected survival time:> 12 weeks.

         12. Patients who can cooperate with the observation of adverse events and efficacy.

         13. Patients or their legal representatives have signed a written informed consent form.

        Exclusion Criteria:

          1. Acute hepatitis C, chronic hepatitis C and active hepatitis B (positive HBsAg; HBcAb
             or HBeAb positive and HBV DNA positive).

          2. HIV antibody positive, or other acquired, congenital immunodeficiency disease, or a
             history of organ transplantation.

          3. A past history of interstitial lung disease and radiation pneumonia.

          4. 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.

          5. 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;

          6. 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.

          7. 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.

          8. Patients who have previously administered third-generation EGFR-TKI drugs
             (e.g.,AZD9291, Avitinib, CO-1686, HM61713, etc.).

          9. Patients who have been registered and received the study treatment or withdrawn from
             the study cannot be enrolled.

         10. Pregnant or lactating women.

         11. 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.

         12. Patients who are considered by the investigator as inappropriate to participate in the
             study.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:DoR (Duration of Response)
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.
Safety Issue:
Description:To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure:PFS (Progression-free survival)
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.
Safety Issue:
Description:To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure:DCR (Disease control 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.
Safety Issue:
Description:To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure:OS (Overall survival)
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.
Safety Issue:
Description:To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Measure:The lung cancer symptoms and health-related quality of life (HRQoL)
Time Frame: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.
Safety Issue:
Description:To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hangzhou ACEA Pharmaceutical Research Co.,Ltd.

Last Updated

October 8, 2017