Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT01683175
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

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

Interventions

Study Details

This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.

Key Dates

Start date
Aug 31, 2012
Status verified
Oct 2016
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020

Study Design

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

Arms

  • Experimental: Arm 1
    Erlotinib 150mg daily oral up to 2 years
  • Active Comparator: Arm 2
    NP Chemotherapy for 4 cycles

Primary Outcome Measure

2-year disease free survival rate (DFSR) [ Time Frame: 2 years ]

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