Clinical trial NCT01287962: Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
Official title: Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Apatinib
Non-small Cell Lung Cancer
VEGFR TKIs
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 24 months
Secondary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: 24 months
measure: Overall Survival(OS)
timeFrame: 24 months
measure: Toxicity
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-Sen University (CCSU)
state: Guangdong
Study officials:
affiliation: Cancer Center of Sun Yat-Sen University (CCSU)
name: Li Zhang, MD
role: STUDY_CHAIR
References: