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

Phase 3

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: apatinib; Drug: placebo

• Registration Number: NCT01287962
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Study Start: 2011-04
• Status Verified: 2012-01
• Primary Completion: 2013-04
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-09
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib	apatinib	750 mg，po，QD； 28 days every cycle
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	24 months	Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	24 months	ORR was the percentage of patients who got partial or complete response
Overall Survival(OS)	24 months	OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up
Toxicity	24 months	Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.

Trial Locations

Locations (1)

Cancer Center of Sun Yat-Sen University (CCSU); 🇨🇳 Guangzhou, Guangdong, China