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A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

NCT01260181

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Interventions: Erlotinib

Countries: Portugal

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 growth factor receptor (EGFR) mutations.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Locally advanced or metastatic NSCLC with EGFR mutations
* Measurable disease according to RECIST criteria
* Adequate hematological, renal and liver function

Exclusion Criteria:

* 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
Locations (9)
  • Aveiro, Portugal
  • Coimbra, Portugal
  • Lisbon, Portugal
  • Lisbon, Portugal
  • Lisbon, Portugal
  • Lisbon, Portugal
  • Porto, Portugal
  • Porto, Portugal
  • Vila Nova de Gaia, Portugal