Condition or disease | Intervention/treatment | Phase |
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ROS1-positive Non-Small Cell Lung Cancer (NSCLC) | Drug: TQ-B3101 | Phase 2 |
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 |
Arm | Intervention/treatment |
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Experimental: TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
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Drug: TQ-B3101
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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:
Contact: Shun Lu, Doctor | 021-22200000*3121 | shun-lu@hotmail.com |
Tracking Information | |||||
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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 |
Overall response rate (ORR) [ Time Frame: up to approximately 20 months ] Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 |
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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.
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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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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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 |