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

August 13, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Chest Hospital
    • Beijing
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Tumor Hospital, Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 10000
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Tumor Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Affiliated tumor hospital of sun yat-sen university
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
          • Xicheng Wang, Doctor
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical College
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150000
        • Recruiting
        • Affiliated Tumor Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Tumor Hospital
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Hunan Provincial Tumor Hospital
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Hospital of Centre-South University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Second Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
      • Linyi, Shandong, China, 276000
        • Not yet recruiting
        • Linyi Tumor Hospital
        • Contact:
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • Qingdao University Medical College Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Jiaotong University Affiliated Chest Hospital
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • The First Affiliated Hospital of Xi 'an Jiaotong University
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Not yet recruiting
        • Tianjin Tumor Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital School of Medical,Zhejiang University
        • Contact:
          • Hongming Pan, Doctor
          • Phone Number: 057186006926
          • Email: shonco@sina.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to approximately 24 months
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.
up to approximately 20 months
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).
up to approximately 20 months
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.
up to approximately 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2019

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (ACTUAL)

June 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-B3101-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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