ALK-positive NSCLCPhase 2NCT04056572
Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
A Phase 2 study testing TQ-B3139 in people with ALK-positive NSCLC, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ALK-positive NSCLC
- 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
- 135 participants
- Where
- 2 sitesChina
- Study dates
- 13 Aug 2019to 30 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy ≥12 weeks.
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
- Has progressive disease during or after crizotinib treatment.
- Has a measurable disease.
- Adequate organ system function.
- Understood and signed an informed consent form.
Who cannot join
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
- Hypersensitivity to TQ-B3139 capsule.
- Has received ALK TKIs other than crizotinib.
- Has received any cancer therapy within 4 weeks or 5 times of t1/2.
- Has received major surgery within 4 weeks.
- Has received any radiotherapy or minor surgery within 2 weeks.
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- Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
- Has active viral, bacterial and fungal infections within 2 weeks.
- Has serious cardiovascular diseases.
- Has currently uncontrollable congestive heart failure.
- Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval > 480ms.
- Has interstitial fibrosis or interstitial lung disease.
- Brain metastases with symptom or carcinomatous meningitis.
- Has active hepatitis B or hepatitis C.
- Has multiple factors affecting oral medication.
- Breastfeeding or pregnant women.
- According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Nong Yang, Doctor, +86-731-88651900, yangnong0217@163.com
Nong Yang, Doctor
- Recruiting
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510050
Li Zhang, Doctor, 020-87343088, zhangli@sysucc.org.cn
Li zhang, Doctor
About this study
Official title: A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Patients With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib.
To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.
- Conditions
- ALK-positive NSCLC
- Being tested
- TQ-B3139
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3139Drug
TQ-B3139 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS.
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3139 | Experimental | TQ-B3139 tablet 600mg administered orally, twice daily. 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)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Measured: up to 36 months
Secondary outcomes (3)
Progression-free survival (PFS)
The time from randomization to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.
Measured: up to 36 months
Disease control rate (DCR)
Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).
Measured: up to 36 months
Overall survival (OS)
Time from date of randomization to date of death due to any cause.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start13 Aug 2019
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-positive NSCLCStudies 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
- 135 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
- NCT04056572
- Sponsor's protocol ID
- TQ-B3139-II-01
- Status last verified
- May 2019
- First submitted
- 12 Aug 2019
- Last updated
- 30 Oct 2019
- 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 30 Oct 2019. 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 Patients With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib.
- ClinicalTrials.gov ID
- NCT04056572
- Acronym / sponsor ID
- TQ-B3139-II-01
- Conditions
- ALK-positive NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 14 Aug 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 evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.
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 | Experimental | Drug: TQ-B3139TQ-B3139 tablet 600mg administered orally, twice daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy ≥12 weeks.
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
- Has progressive disease during or after crizotinib treatment.
Key exclusion criteria (17 listed)
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
- Hypersensitivity to TQ-B3139 capsule.
- Has received ALK TKIs other than crizotinib.
- Has received any cancer therapy within 4 weeks or 5 times of t1/2.
- Has received major surgery within 4 weeks.
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 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS. | Drug | TQ-B3139 |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 36 months
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
3 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 36 months
Overall survival (OS)
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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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.
2 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 ALK-positive NSCLC, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 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 8 inclusion and 17 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Li Zhang, Doctor (020-87343088, zhangli@sysucc.org.cn), 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 36 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 30 Oct 2019.