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)

NCT01512420 | Completed

• 1 other identifier: ML27773
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 41

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 wild-type epidermal growth factor receptor (EGFR) gene. The aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line Tarceva treatment. Data will be collected from eligible patients for up to 2 years.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Correlation of overall survival with baseline clinical/demographic patient characteristics

  approximately 2 years

• Correlation of overall survival with baseline tumour characteristics

  approximately 2 years

• Correlation of overall survival with previous treatment regimens

  approximately 2 years

Secondary Outcomes (4)

• Objective response rate (ORR), tumour assessments according to RECIST criteria

  approximately 2 years

• Disease control rate

  approximately 2 years

• Progression-free survival

  approximately 2 years

• Safety: Incidence of adverse events

  approximately 2 years

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with previously treated advanced NSCLC, with wild-type EGFR gene or squamous cell carcinoma histology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (41)

Unknown Facility

Vitoria-Gasteiz, Alava, 01009, Spain

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Elda, Alicante, 03600, Spain

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Maó, Balearic Islands, 07703, Spain

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Barcelona, Barcelona, 08006, Spain

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Barcelona, Barcelona, 08036, Spain

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Barcelona, Barcelona, 08041, Spain

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Barcelona, Barcelona, 08916, Spain

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Cáceres, Caceres, 10003, Spain

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Santander, Cantabria, 39008, Spain

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Girona, Girona, 17007, Spain

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Donostia / San Sebastian, Guipuzcoa, 20080, Spain

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Barbastro, Huesca, 22300, Spain

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Huesca, Huesca, 22004, Spain

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A Coruña, La Coruña, 15006, Spain

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Santiago de Compostela, La Coruña, 15706, Spain

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Logroño, La Rioja, 26006, Spain

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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

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León, Leon, 24071, Spain

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Lugo, Lugo, 27003, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28046, Spain

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Madrid, Madrid, 28905, Spain

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Melilla, Malaga, 52005, Spain

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Oviedo, Principality of Asturias, 33011, Spain

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Salamanca, Salamanca, 37007, Spain

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Reus, Tarragona, 43204, Spain

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San Cristóbal de La Laguna, Tenerife, 38320, Spain

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Teruel, Teruel, 44002, Spain

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Toledo, Toledo, 45004, Spain

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Valencia, Valencia, 41014, Spain

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Valencia, Valencia, 46015, Spain

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Valencia, Valencia, 46017, Spain

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Valencia, Valencia, 46026, Spain

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Xàtiva, Valencia, 46800, Spain

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Valladolid, Valladolid, 47005, Spain

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Bilbao, Vizcaya, 48013, Spain

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Zamora, Zamora, 49021, Spain

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Unknown Facility

Zaragoza, Zaragoza, 50009, Spain

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: January 19, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

ES (41)