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出境医 / 临床实验 / Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Study Description
Brief Summary:
To assess efficacy and safety of oral TQ-B3101 administered to patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that confirmed ROS1 positive gene mutation.

Condition or disease Intervention/treatment Phase
ROS1-positive Non-Small Cell Lung Cancer (NSCLC) Drug: TQ-B3101 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open Label, Single Arm Study of the Efficacy and Safety of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : July 24, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
Drug: TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.

Outcome Measures
Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: up to approximately 20 months ]
    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: up to approximately 20 months ]
    DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.

  2. Disease control rate (DCR) [ Time Frame: up to approximately 20 months ]
    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

  3. Progression-free survival (PFS) [ Time Frame: up to approximately 20 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  4. Overall survival (OS) [ Time Frame: up to approximately 24 months ]
    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.18 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;Life expectancy ≥ 3 months.

3.Understood and Signed an informed consent form. 4.Histologically or cytologically confirmed locally advanced or metastatic NSCLC .

5.Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive.

6. Had received no more than two chemotherapy regimens. 7.At least 1 measurable tumor lesion other than brain lesions within 28 days before first dose based on RECIST 1.1.

8.The main organs function are normally, the following criteria are met:

  1. routine blood tests(no blood transfusion and blood products within 14 days):hemoglobin(Hb)≥90g/L;absolute neutrophil count(ANC)≥1.5×109/L; platelets(PLT)≥100×109/L.
  2. Blood biochemical examination: alanine transaminase(ALT)and aspartate aminotransferase(AST)≤2.5×upper limit of normal (ULN)(when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ); total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);Serum creatinine ≤ 1.5 × upper limit of normal (ULN); or creatinine clearance calculated ≥ 50ml / min (calculated according to Cockcroft-Gault formula);
  3. left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography ≥ 50%.

    9.Women must meet one of the following conditions:has undergone surgical sterilization;have been menopausal at least 1 year;have fertility, the following conditions must be met;Serum pregnancy test results were negative; throughout the study period to 6 months after the last dose, agreed to adopt an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier-effect Contraceptive methods, spermicides and condoms, or intrauterine devices).Men must meet one of the following conditions:has surgical sterilization;an approved method of contraception must be used throughout the study period and 6 months after the last dose.

    Exclusion Criteria:

    1. Has any known endothelial growth factor receptor (EGFR) positive mutation.
    2. Prior therapy with crizotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or any other ROS1 inhibitor.
    3. Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
    4. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、 non-melanoma skin cancers and superficial bladder tumors.
    5. Has a history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension.
    6. Has clinically significant, uncontrolled cardio-cerebral vascular disease.
    7. Has major surgery and anti-tumor treatment before two weeks of treatment and participated in other drug clinical trials within four weeks.
    8. Has known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, and pia mater disease.
    9. Has in screening period confirmed HCV positive, HIV positive, active syphilis positive, or HBsAg positive, HBV DNA titers >500 copies/ml and stable time <14 days after symptomatic treatment,or has a history of stem cells and organ transplantation.
    10. Has history of psychotropic substance abuse that unable to abstain from or mental disorder.
    11. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Contacts and Locations

Contacts
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Contact: Shun Lu, Doctor 021-22200000*3121 shun-lu@hotmail.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
Overall response rate (ORR) [ Time Frame: up to approximately 20 months ]
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Duration of Response (DOR) [ Time Frame: up to approximately 20 months ]
    DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
  • Disease control rate (DCR) [ Time Frame: up to approximately 20 months ]
    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
  • Progression-free survival (PFS) [ Time Frame: up to approximately 20 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
  • Overall survival (OS) [ Time Frame: up to approximately 24 months ]
    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE Phase II, Open Label, Single Arm Study of the Efficacy and Safety of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Brief Summary To assess efficacy and safety of oral TQ-B3101 administered to patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that confirmed ROS1 positive gene mutation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE Drug: TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
Study Arms  ICMJE Experimental: TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
Intervention: Drug: TQ-B3101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
111
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1.18 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;Life expectancy ≥ 3 months.

3.Understood and Signed an informed consent form. 4.Histologically or cytologically confirmed locally advanced or metastatic NSCLC .

5.Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive.

6. Had received no more than two chemotherapy regimens. 7.At least 1 measurable tumor lesion other than brain lesions within 28 days before first dose based on RECIST 1.1.

8.The main organs function are normally, the following criteria are met:

  1. routine blood tests(no blood transfusion and blood products within 14 days):hemoglobin(Hb)≥90g/L;absolute neutrophil count(ANC)≥1.5×109/L; platelets(PLT)≥100×109/L.
  2. Blood biochemical examination: alanine transaminase(ALT)and aspartate aminotransferase(AST)≤2.5×upper limit of normal (ULN)(when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ); total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);Serum creatinine ≤ 1.5 × upper limit of normal (ULN); or creatinine clearance calculated ≥ 50ml / min (calculated according to Cockcroft-Gault formula);
  3. left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography ≥ 50%.

    9.Women must meet one of the following conditions:has undergone surgical sterilization;have been menopausal at least 1 year;have fertility, the following conditions must be met;Serum pregnancy test results were negative; throughout the study period to 6 months after the last dose, agreed to adopt an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier-effect Contraceptive methods, spermicides and condoms, or intrauterine devices).Men must meet one of the following conditions:has surgical sterilization;an approved method of contraception must be used throughout the study period and 6 months after the last dose.

    Exclusion Criteria:

    1. Has any known endothelial growth factor receptor (EGFR) positive mutation.
    2. Prior therapy with crizotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or any other ROS1 inhibitor.
    3. Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
    4. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、 non-melanoma skin cancers and superficial bladder tumors.
    5. Has a history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension.
    6. Has clinically significant, uncontrolled cardio-cerebral vascular disease.
    7. Has major surgery and anti-tumor treatment before two weeks of treatment and participated in other drug clinical trials within four weeks.
    8. Has known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, and pia mater disease.
    9. Has in screening period confirmed HCV positive, HIV positive, active syphilis positive, or HBsAg positive, HBV DNA titers >500 copies/ml and stable time <14 days after symptomatic treatment,or has a history of stem cells and organ transplantation.
    10. Has history of psychotropic substance abuse that unable to abstain from or mental disorder.
    11. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shun Lu, Doctor 021-22200000*3121 shun-lu@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972189
Other Study ID Numbers  ICMJE TQ-B3101-II-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor  ICMJE Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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