Non Small Cell Lung CancerPhase 2NCT04398940
A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
A Phase 2 study testing TQ-B3139 in people with Non Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
Trial summary
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- TQ-B3139
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 16 sitesChina
- Study dates
- 11 Aug 2020to 31 Oct 2022
- 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form.
Who cannot join
- 1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Not yet recruiting
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100010
Zhihai Han, Doctor, 010-66957581, hanzhihai@souhu.com
Zhihai Han, Doctor
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Junling Li, Doctor, 010-87788713, drlijunling@vip.163.com
Junling Li, Doctor
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Zhang, Doctor, 010-83192232, steven9130@sina.com
Yi Zhang, Doctor
- Not yet recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Hong Wang, Doctor, 010-66947163, 18611707961@163.com
Hong Wang, Doctor
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jian Fang, 010-88196479
Jian Fang
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Jianhua Chen, Doctor, 0731-89762220, cjh_1000@163.com
Jianhua Chen, Doctor
- Not yet recruiting
Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Hangzhou, 310016
Kejing Ying, Doctor, 0571-86006192, yingsrrsh@163.com
Kejing Ying, Doctor
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Hangzhou, 310022
Xinmin Yu, 0571-88122084, yuxm@zjcc.org.cn
Xinmin Yu
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Gongyan Chen, Doctor, 0451-86298265, chengongyan@163.com
Gongyan Chen, Doctor
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Yueyin Pan, Doctor, 0551-2283114, yueyinpan1965@126.com
Yueyin Pan, Doctor
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Meiqi Shi, 025-83283568, shimeiqi1963@163.com
Meiqi Shi
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Qitao Yu, 0771-5328331, yqt178@163.com
Qitao Yu
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Baohui Han, Doctor, 021-22200000
Baohui Han, Doctor
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jialei Wang, luwangjialei@hotmail.com
Jialei Wang
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300041
Diansheng Zhong, Doctor, 022-60817007, zhongdsh@hotmail.com
Diansheng Zhong, Doctor
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang, Doctor, 400-0371-818, qimingwang1006@126.com
Qiming Wang, Doctor
About this study
Official title: A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- TQ-B3139
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3139Drug
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3139 capsules | Experimental | TQ-B3139 capsules administered orally. Receives: Drug: TQ-B3139 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Measured: up to 18 months
Secondary outcomes (7)
Progression-free survival (PFS)
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Measured: up to 18 months
Disease control rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 18 months
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Measured: up to 24 months
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 18 months
Intracranial progression-free survival (CNS-PFS)
The time from enrollment to the first confirmed intracranial progression for brain metastases.
Measured: up to 18 months
Intracranial objective response rate (CNS-ORR)
Percentage of subjects achieving intracranial complete response and partial response.
Measured: up to 18 months
Time to progress of intracranial disease (CNS-TTP)
The time from the first dose to the first occurrence of intracranial disease progression.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start11 Aug 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- 71 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
- NCT04398940
- Sponsor's protocol ID
- TQ-B3139-II-02
- Status last verified
- Nov 2019
- First submitted
- 19 May 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04398940
- Acronym / sponsor ID
- TQ-B3139-II-02
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 22 May 2020 (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.
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3139 capsules | Experimental | Drug: TQ-B3139TQ-B3139 capsules administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form.
Key exclusion criteria (1 listed)
- 1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
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-B3139TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle. | Drug | TQ-B3139 capsules |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR).
7 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 18 months
Disease control rate (DCR)
Time frame: up to 18 months
Overall survival (OS)
Time frame: up to 24 months
Duration of Response (DOR)
Time frame: up to 18 months
Intracranial progression-free survival (CNS-PFS)
Time frame: up to 18 months
Intracranial objective response rate (CNS-ORR)
Time frame: up to 18 months
Time to progress of intracranial disease (CNS-TTP)
Time frame: up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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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.
16 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-B3139 in people with Non Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 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 1 inclusion and 1 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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Baohui Han, Doctor (021-22200000, 18930858216@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2020.