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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01287962
Recruitment Status : Unknown
Verified January 2012 by Li Zhang, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2011
Last Update Posted : December 9, 2013
Information provided by (Responsible Party):
Li Zhang, 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: apatinib Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2011
Actual Primary Completion Date : April 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Apatinib
750 mg,po,QD; 28 days every cycle
Drug: apatinib
750 mg,po,QD; 28 days every cycle
Placebo Comparator: Placebo Drug: placebo
po,QD; 28 days every cycle

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 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 :
  1. Objective Response Rate(ORR) [ Time Frame: 24 months ]
    ORR was the percentage of patients who got partial or complete response

  2. Overall Survival(OS) [ Time Frame: 24 months ]
    OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up

  3. Toxicity [ Time Frame: 24 months ]
    Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01287962

China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)

Responsible Party: Li Zhang, Professor, Sun Yat-sen University Identifier: NCT01287962     History of Changes
Other Study ID Numbers: HENGRUI 20110301
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: January 2012

Keywords provided by Li Zhang, Sun Yat-sen University:
Non-small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms