Status:
COMPLETED
An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational study will evaluate the efficacy and safety of second-line Tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wil...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Patients with known wild-type EGFR gene; patients with unknown EGFR mutation status are allowed if they fulfil the following criteria:
- squamous cell carcinoma lung cancer histology, and
- current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of \>15 pack-years of smoking
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with Tarceva
Exclusion
- Current treatment with an investigational drug or participation in another investigational study
- Severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin
- Clinically active interstitial lung disease
- Recent myocardial infarction or unstable angina
- Progressive or uncontrolled brain metastases
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT01512420
Start Date
November 1 2011
End Date
February 1 2015
Last Update
November 2 2016
Active Locations (41)
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1
Vitoria-Gasteiz, Alava, Spain, 01009
2
Elda, Alicante, Spain, 03600
3
Maó, Balearic Islands, Spain, 07703
4
Palma de Mallorca, Balearic Islands, Spain, 07014