Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLC

Sponsor
Fuzhou General Hospital
Study ID
NCT03256721
Phase
PHASE2
Status
Terminated

Conditions

  • Nonsmall Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib/docetaxel/pemetrexed — DRUG
    Participants are randomly assigned to treatment group or control group
  • docetaxel/pemetrexed — DRUG
    Participants are randomly assigned to treatment group or control group

Study Details

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.

Key Dates

Start date
Aug 16, 2017
Status verified
Aug 2018
Primary completion
Mar 27, 2019
Completion
Aug 16, 2019

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib+docetaxel/pemetrexed
    Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
  • Active Comparator: docetaxel/pemetrexed
    docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d

Primary Outcome Measure

progression-free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]

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