Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT03389256
Phase
PHASE2
Status
Unknown

Conditions

  • Lung Diseases
  • Neoplasms
  • Non-Small-Cell Lung
  • Respiratory Tract Diseases
  • Thoracic Neoplasms

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Apatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week.
  • EGFR-TKI — DRUG
    Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po

Study Details

This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.

Key Dates

Start date
Dec 30, 2018
Status verified
Dec 2017
Primary completion
Dec 30, 2020
Completion
Aug 30, 2022

Study Design

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

Arms

  • Experimental: apatinib combine with EGFR-TKI
    Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity
  • Active Comparator: EGFR-TKI
    Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity

Primary Outcome Measure

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

Central Contacts

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