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)

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Keywords

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Gender

ALL

Eligibility criteria

• 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.