Status:
COMPLETED
A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT01250119
Start Date
March 1 2011
End Date
May 1 2014
Last Update
March 14 2016
Active Locations (22)
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1
Belfast, United Kingdom, BT47 6SB
2
Belfast, United Kingdom, BT9 7AB
3
Bradford, United Kingdom, BD9 6RJ
4
Brighton, United Kingdom, BN2 5BE