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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972189
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972189


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.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03972189    
Other Study ID Numbers: TQ-B3101-II-01
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms