Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Patients 18 to 70 years of age

2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions

3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy

4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1

5. Patients had to have recovered from any toxic effects of therapy

6. Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation

7. Adequate hematologic and biochemical values were required

Exclusion Criteria:

1. Presence of small-cell lung cancer alone or with NSCLC

2. Pregnant or breast-feeding women

3. Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure > 140 mmHg，diastolic pressure > 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency

4. Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction)

5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy

6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks

7. Bone fracture or wounds that was not cured for a long time

8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents

9. Mental diseases and psychotropic substances abuse

10. Previous treatment with an experimental agent within 4 weeks

11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS

12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)