Study of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT02332512
Phase
PHASE3
Status
Unknown

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

Study Details

Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC. The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.

Key Dates

Start date
Jan 31, 2015
Status verified
Jan 2017
Primary completion
Aug 31, 2017
Completion
Oct 31, 2017

Study Design

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

Arms

  • Experimental: Apatinib
    Apatinib tablet administered orally, 750 mg,once daily until progression
  • Placebo Comparator: Placebo
    Placebo tablet administered orally, once a day until progression

Primary Outcome Measure

Overall Survival（OS) [ Time Frame: 24 months ]

Central Contacts

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