Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments apatinib, placebo
Phase phase 3
Targets VEGF, KIT
Sponsor Sun Yat-sen University
Start date April 2011
End date April 2013
Trial size 480 participants
Trial identifier NCT01287962, HENGRUI 20110301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
750 mg,po,QD; 28 days every cycle
apatinib
750 mg,po,QD; 28 days every cycle
(Placebo Comparator)
placebo
po,QD; 28 days every cycle

Primary Outcomes

Measure
Progression free survival (PFS)
time frame: 24 months

Secondary Outcomes

Measure
Objective Response Rate(ORR)
time frame: 24 months
Overall Survival(OS)
time frame: 24 months
Toxicity
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.