Status:
COMPLETED
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal gro...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic NSCLC with EGFR mutations
- Measurable disease according to RECIST criteria
- Adequate hematological, renal and liver function
Exclusion
- Previous chemotherapy or therapy against EGFR for metastatic disease
- Symptomatic cerebral metastases
- Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
- History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
- Concomitant use of coumarins
Key Trial Info
Start Date :
March 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01260181
Start Date
March 31 2011
End Date
September 29 2017
Last Update
October 31 2018
Active Locations (9)
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1
Hospital Infante D. Pedro; Servico de Oncologia Medica
Aveiro, Portugal, 3814-501
2
Hospital Geral; Servico de Pneumologia
Coimbra, Portugal, 3041-801
3
IPO de Lisboa; Servico de Pneumologia
Lisbon, Portugal, 1099-023
4
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
Lisbon, Portugal, 1150-314