EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

Sponsor
Fujian Cancer Hospital
Study ID
NCT02886195
Phase
PHASE3
Status
Unknown

Conditions

  • EGFR Gene Mutation

Eligibility Criteria

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

Interventions

  • pemetrexed — DRUG
    500mg/m2 ivgtt d1, per three weeks
  • cisplatin — DRUG
    80mg/m2 ivgtt d1, per three weeks
  • Erlotinib — DRUG
    150mg po. every day

Study Details

The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).

Key Dates

First listed
Sep 1, 2016
Start date
Jul 31, 2016
Status verified
Jul 2016
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019

Study Design

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

Arms

  • Experimental: PC plus erlotinib
    pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy
  • Active Comparator: erlotinib
    erlotinib 150mg/d until "progress disease"
  • Active Comparator: PC
    pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 6 months ]

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