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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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ALK-positive NSCLC

Intervention / Treatment
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* Drug: TQ-B3139
* Drug: Crizotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3139<br>TQ-B3139 tablet 600mg administered orally , twice daily in 28-day cycle. | Drug: TQ-B3139<br>* a multi-target protein kinase inhibitor.<br>|
| Active Comparator: Crizotinib<br>Crizotinib tablet 250mg administered orally, twice daily in 28-day cycle. | Drug: Crizotinib<br>* a multi-target protein kinase inhibitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | up to 36 months | 
| Disease Control rate (DCR) | Percentage of subjects achieving CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD) | up to 36 months | 
| 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. | up to 36 months |