Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

Sponsor
Chinese Society of Lung Cancer
Study ID
NCT01024413
Phase
PHASE3
Status
Completed

Conditions

  • Thoracic Neoplasms

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib — DRUG
    study arm.erlotinib 150 mg oral till disease progression
  • gefitinib — DRUG
    study arm.gefitinib 250 mg oral till disease progression

Study Details

This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Key Dates

First listed
Dec 2, 2009
Start date
Jul 31, 2009
Status verified
Feb 2017
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: erlotinib
    erlotinib 150 mg oral till disease progression
  • Active Comparator: gefitinib
    gefitinib 250mg oral till disease progression.

Primary Outcome Measure

progression-free survival [ Time Frame: two years ]

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