ROS1-positive Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT03972189
Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing TQ-B3101 in people with ROS1-positive Non-Small Cell Lung Cancer (NSCLC), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- TQ-B3101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 22 sitesChina
- Study dates
- 24 Jul 2019to Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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);
- 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.
Who cannot join
- Has any known endothelial growth factor receptor (EGFR) positive mutation.
- Prior therapy with crizotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or any other ROS1 inhibitor.
- Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
- 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.
- Has a history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension.
- Has clinically significant, uncontrolled cardio-cerebral vascular disease.
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- Has major surgery and anti-tumor treatment before two weeks of treatment and participated in other drug clinical trials within four weeks.
- Has known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, and pia mater disease.
- 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.
- Has history of psychotropic substance abuse that unable to abstain from or mental disorder.
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites, 22 recruiting
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Yi Hu, Doctor, huyi0401@aliyun.com
- Not yet recruiting
Tumor hospital, Chinese academy of medical sciences
Beijing, Beijing Municipality, 100000
Yan Wang, Doctor, wangyanyifu@163.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 10000
Jian Fang, Doctor, fangjian5555@163.com
- Not yet recruiting
Second hospital of jilin university
Changchun, Jilin, 130000
Jie Zhang, Doctor, doctorzhangj@sina.com
- Recruiting
Hunan provincial tumor hospital
Changsha, Hunan, 410000
Lin Wu, Doctor, wulin-calf@vip.163.com
- Recruiting
Xiangya Hospital of Centre-south University
Changsha, Hunan, 410000
Huaping Yang, Doctor, lyhuaping@aliyun.com
- Recruiting
The second affiliated hospital of dalian medical university
Dalian, Liaoning, 116000
Yang Zhang, Doctor, zydl@medmail.com.cn
- Not yet recruiting
Fujian Tumor Hospital
Fuzhou, Fujian, 350000
Wu Zhuang, Doctor, zhuangwu2008@126.com
- Recruiting
Affiliated tumor hospital of sun yat-sen university
Guangzhou, Guangdong, 510000
Xiuyu Cai, Doctor, caixy@sysucc.org.cn
- Recruiting
The first affiliated hospital of guangdong pharmaceutical university
Guangzhou, Guangdong, 510000
Xicheng Wang, Doctor
- Recruiting
The first affiliated hospital of guangzhou medical college
Guangzhou, Guangdong, 510000
Jianxing He, Doctor, 020-83062902, Hejx@vip.163.com
- Recruiting
Sir Run Run Shaw Hospital School of Medical,Zhejiang University
Hangzhou, Zhejiang, 310016
Hongming Pan, Doctor, 057186006926, shonco@sina.cn
- Recruiting
Affiliated tumor hospital of Harbin medical university
Harbin, Heilongjiang, 150000
Yan Yu, Doctor, gpyuyan@163.com
- Recruiting
Anhui chest hospital
Hefei, Anhui, 230000
Xuhong Min, Doctor, 1320722827@qq.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Xiuwen Wang, Doctor, wangxiuwen@medmail.com.cn
- Not yet recruiting
Linyi tumor hospital
Linyi, Shandong, 276000
Jianhua Shi, Doctor, lyzlyygcp@126.com
- Not yet recruiting
Qingdao University Medical College Hospital
Qingdao, Shandong, 266000
Zhuang Yu, Doctor, yuzhang2002@163.com
- Recruiting
Shanghai Jiaotong University Affiliated Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, doctor, 021-22200000*3121, shun-lu@hotmail.com
- Not yet recruiting
Tianjin tumor hospital
Tianjin, Tianjin Municipality, 300000
Kai Li, Doctor, likai_fnk@163.com
- Recruiting
The first affiliated hospital of xi 'an jiaotong university
Xi’an, Shanxi, 710000
Yu Yao, Doctor
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Shundong Cang, Doctor, cangshundong@163.com
- Not yet recruiting
Henan Tumor Hospital
Zhengzhou, Henan, 450000
Zhiyong Ma, Doctor
About this study
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)
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.
- Being tested
- TQ-B3101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3101Drug
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3101 | Experimental | TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle. Receives: Drug: TQ-B3101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
Measured: up to approximately 20 months
Secondary outcomes (4)
Duration of Response (DOR)
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.
Measured: up to approximately 20 months
Disease control rate (DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: up to approximately 20 months
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to approximately 20 months
Overall survival (OS)
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.
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start24 Jul 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ROS1-positive Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972189
- Sponsor's protocol ID
- TQ-B3101-II-01
- Status last verified
- Aug 2019
- First submitted
- 31 May 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z.
PubMed 37385995
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03972189
- Acronym / sponsor ID
- TQ-B3101-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3101 | Experimental | Drug: TQ-B3101TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ-B3101TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle. | Drug | TQ-B3101 |
Primary outcome
Overall response rate (ORR)
Time frame: up to approximately 20 months
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
4 secondary outcomes
Duration of Response (DOR)
Time frame: up to approximately 20 months
Disease control rate (DCR)
Time frame: up to approximately 20 months
Progression-free survival (PFS)
Time frame: up to approximately 20 months
Overall survival (OS)
Time frame: up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 37385995Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQ-B3101 in people with ROS1-positive Non-Small Cell Lung Cancer (NSCLC), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shun Lu, Doctor (021-22200000*3121, shun-lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: up to approximately 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.