Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00615758
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib at the dose of 150 mg orally once a day continually until progression

Study Details

To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population

Key Dates

First listed
Feb 14, 2008
Start date
Oct 31, 2006
Status verified
Dec 2009
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Tarceva

Primary Outcome Measure

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

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