Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)
- ECOG performance status 0-3
- Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation
in the diagnostic phase of the study
- Adequate haematological, liver and renal function
- Female patients must be postmenopausal, surgically sterile, or agree to use a barrier
method of contraception
- Male patients must be surgically sterile or agree to use a barrier method of
contraception
Exclusion Criteria:
- Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with
antibody or small molecule (tyrosine kinase inhibitor)
- Symptomatic cerebral metastases
- Pregnant or lactating women
- Any other concomitant anti-cancer therapy (until disease progression and
discontinuation of Tarceva therapy)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prevalence of epidermal growth factor receptor (EGFR) mutation in NSCLC patients in the UK
Outcome Time Frame:
18 months (diagnostic phase)
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United Kingdom: Ministry of Health
Study ID:
ML25279
NCT ID:
NCT01250119
Start Date:
March 2011
Completion Date:
December 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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