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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01287962
• Other study ID #: HENGRUI 20110301
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 31, 2011
• Last updated: December 5, 2013
• Start date: April 2011
• Est. completion date: March 2014

Study information

• Verified date: January 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: March 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• apatinib
750 mg,po,QD; 28 days every cycle
• placebo
po,QD; 28 days every cycle

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-Sen University (CCSU)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.	24 months	No
Secondary	Objective Response Rate(ORR)	ORR was the percentage of patients who got partial or complete response	24 months	No
Secondary	Overall Survival(OS)	OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up	24 months	No
Secondary	Toxicity	Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.	24 months	Yes