Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

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.

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 diagnosis of advanced or metastatic NSCLC that is ALK-positive.
5. Has progressive disease during or after crizotinib treatment.
6. Has a measurable disease.
7. Adequate organ system function.
8. Understood and signed an informed consent form.

Exclusion Criteria:

1. Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
2. Hypersensitivity to TQ-B3139 capsule.
3. Has received ALK TKIs other than crizotinib.
4. Has received any cancer therapy within 4 weeks or 5 times of t1/2.
5. Has received major surgery within 4 weeks.
6. Has received any radiotherapy or minor surgery within 2 weeks.
7. Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
8. Has active viral, bacterial and fungal infections within 2 weeks.
9. Has serious cardiovascular diseases.
10. Has currently uncontrollable congestive heart failure.
11. Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval > 480ms.
12. Has interstitial fibrosis or interstitial lung disease.
13. Brain metastases with symptom or carcinomatous meningitis.
14. Has active hepatitis B or hepatitis C.
15. Has multiple factors affecting oral medication.
16. Breastfeeding or pregnant women.
17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.