Clinical Trials /

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

NCT03972189

Description:

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.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: TQ-B3101-II-01
  • NCT ID: NCT03972189

Conditions

  • ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
TQ-B3101TQ-B3101

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TQ-B3101ExperimentalTQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
  • TQ-B3101

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:up to approximately 20 months
Safety Issue:
Description:Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:up to approximately 20 months
Safety Issue:
Description: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.
Measure:Disease control rate (DCR)
Time Frame:up to approximately 20 months
Safety Issue:
Description:Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measure:Progression-free survival (PFS)
Time Frame:up to approximately 20 months
Safety Issue:
Description:PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measure:Overall survival (OS)
Time Frame:up to approximately 24 months
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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