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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC0010 | Experimental | Each participant will be given AC0010 300mg bid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC0010 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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;
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanhong Xu, PhD | Contact | +8657128908600 | kayla.liu@aceapharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| 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). |
| 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. |
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Daping Hospital,Research Institute of Surgery Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| The People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | 530000 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| Tongji Medical College of HUST | Recruiting | Wuhan | Hubei | 430000 | China |
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| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
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| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 225000 | China |
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| Jilin Cancer Hospital | Recruiting | Changchun | Jilin | 130000 | China |
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| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250000 | China |
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| Tangdu Hospital | Recruiting | Xi’an | Shanxi | 710000 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Sir Run Run Shaw Hospital,Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000630672 | abivertinib |
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