Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients

Sponsor
Betta Pharmaceuticals Co., Ltd.
Study ID
NCT01040780
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Icotinib — DRUG
    125 mg three times daily (375 mg per day) by mouth
  • Gefitinib — DRUG
    250 mg every 24 hours by mouth

Study Details

The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Key Dates

Start date
Feb 28, 2009
Status verified
Jan 2014
Primary completion
Mar 31, 2010
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: Icotinib
    125 mg three times daily (375 mg per day) by mouth
  • Active Comparator: Gefitinib
    250 mg every 24 hours by mouth

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2-7 months ]

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