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)
NCT ID: NCT01512420
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
355 participants
OBSERVATIONAL
2011-11-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Vitoria-Gasteiz, Alava, Spain
Elda, Alicante, Spain
Mahon, Balearic Islands, Spain
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Cáceres, Caceres, Spain
Santander, Cantabria, Spain
Girona, Girona, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
Barbastro, Huesca, Spain
Huesca, Huesca, Spain
A Coruña, La Coruña, Spain
Santiago de Compostela, La Coruña, Spain
Logroño, La Rioja, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
León, Leon, Spain
Lugo, Lugo, Spain
Alcalá de Henares, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Melilla, Malaga, Spain
Oviedo, Principality of Asturias, Spain
Salamanca, Salamanca, Spain
Reus, Tarragona, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Teruel, Teruel, Spain
Toledo, Toledo, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Xàtiva, Valencia, Spain
Valladolid, Valladolid, Spain
Bilbao, Vizcaya, Spain
Zamora, Zamora, Spain
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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ML27773
Identifier Type: -
Identifier Source: org_study_id