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ALK-positive NSCLCPhase 3NCT04009317

Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing TQ-B3139 and Crizotinib in people with ALK-positive NSCLC, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor. 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 and Crizotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteChina
Study dates
13 Aug 2019to 30 Apr 2022
Phase
Phase 3
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

  • 1.18 and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • 3. Life expectancy ≥12 weeks. 4. Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive.
  • 5. Has not received ALK tyrosine kinase inhibitor (TKI). 6. Has received one chemotherapy regimen for stage IIIB-IV NSCLC. 7. At least one measurable lesion. 8. Adequate organ system function. 9. Understood and signed an informed consent form.

Who cannot join

  • 1. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured cancer carcinoma in situ of the cervix, intramucosal carcinoma of gastrointestinal tract, breast and melanoma skin cancers and superficial bladder tumors.
  • 2. Hypersensitivity to TQ-B3139 or crizotinib. 3. Has received any cancer therapy within 4 weeks or 5 times of t1/2. 4. Has received any major surgery within 4 weeks. 5. Has received any radiotherapy or minor surgery aimed to cure cancer within 2 weeks.
  • 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy. 7. Has active viral, bacterial and fungal infections within 2 weeks before the first dose.
  • 8. Has serious cardiovascular disease within 3 months before the first dose. 9. Has currently uncontrollable congestive heart failure. 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms.
  • 11. Has interstitial fibrosis or interstitial lung disease ≥ Grade 3. 12. Brain metastases with symptom. 13. HBsAg positive and HBV DNA positive (≥ULN);HCV antibody and HCV-RNA positive (≥ULN); HIV positive or ≥HIV ULN.
  • 14. Has multiple factors affecting oral medication. 15. Has received a strong CYP3A inhibitors within 7days before the first dose. 16. Has received a strong CYP3A inducers. 17. Breastfeeding or pregnant women.; Men unwilling to use adequate contraceptive measures during the study.
  • 18. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

Li Zhang, Doctor contact

020-87343088

zhangli@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510050

    Li Zhang, Doctor, 020-87343088, zhangli@sysucc.org.cn

    Li Zhang, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)

To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.

Being tested
TQ-B3139, Crizotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQ-B3139Drug

    a multi-target protein kinase inhibitor.

  • CrizotinibDrug

    a multi-target protein kinase inhibitor.

Study groups in NCT04009317
Study groupRoleWhat they receive
TQ-B3139ExperimentalTQ-B3139 tablet 600mg administered orally , twice daily in 28-day cycle.
Receives: Drug: TQ-B3139
CrizotinibActive comparatorCrizotinib tablet 250mg administered orally, twice daily in 28-day cycle.
Receives: Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 36 months

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Percentage of subjects achieving complete response (CR) and partial response (PR).

    Measured: up to 36 months

  2. Disease Control rate (DCR)

    Percentage of subjects achieving CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD)

    Measured: up to 36 months

  3. Overall Survival (OS)

    OS defined as the time from randomization to death from any cause. Subjects 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 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start13 Aug 2019
  3. Primary completion30 Oct 2021 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009317
Sponsor's protocol ID
TQ-B3139-III-01
Status last verified
Jul 2019
First submitted
2 Jul 2019
Last updated
30 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang Y, Min J, Yang N, Yu Q, Cheng Y, Zhao Y, Li M, Chen H, Ren S, Zhou J, Zhuang W, Qin X, Cao L, Yu Y, Zhang J, He J, Feng J, Yu H, Zhang L, Fang W. Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial. Signal Transduct Target Ther. 2023 Aug 14;8(1):301. doi: 10.1038/s41392-023-01538-w.

    PubMed 37574511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQ-B3139 and Crizotinib in people with ALK-positive NSCLC, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site 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 3 inclusion and 7 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 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-Free Survival (PFS) (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?

On the ClinicalTrials.gov record for NCT04009317, 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 30 Oct 2019.

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