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)

NCT04009317 | Unknown Phase 3

• 1 other identifier: TQ-B3139-III-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALK-positive NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  up to 36 months

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  up to 36 months

• Disease Control rate (DCR)

  up to 36 months

• Overall Survival (OS)

  up to 36 months

Study Arms (2)

TQ-B3139

EXPERIMENTAL

TQ-B3139 tablet 600mg administered orally , twice daily in 28-day cycle.

Drug: TQ-B3139

Crizotinib

ACTIVE COMPARATOR

Crizotinib tablet 250mg administered orally, twice daily in 28-day cycle.

Drug: Crizotinib

Interventions

TQ-B3139 DRUG

a multi-target protein kinase inhibitor.

TQ-B3139

Crizotinib DRUG

a multi-target protein kinase inhibitor.

Crizotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• \. Life expectancy ≥12 weeks. 4. Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK-positive.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510050, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37574511 DERIVED

MeSH Terms

Interventions

Crizotinib

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Li Zhang, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, Doctor

CONTACT

020-87343088; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: August 13, 2019
• Primary Completion: October 30, 2021
• Study Completion: April 30, 2022
• Last Updated: October 30, 2019

Record last verified: 2019-07

Locations

CN (1)