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

Sponsor
Sun Yat-sen University
Study ID
NCT01287962
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    750 mg，po，QD； 28 days every cycle
  • placebo — DRUG
    po，QD； 28 days every cycle

Study Details

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.

Key Dates

Start date
Apr 30, 2011
Status verified
Jan 2012
Primary completion
Apr 30, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib
    750 mg，po，QD； 28 days every cycle
  • Placebo Comparator: Placebo

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 24 months ]

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