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Completed

NCT Number: NCT01512420

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)

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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitoria-Gasteiz, Alava, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Correlation of overall survival with baseline clinical/demographic patient characteristics

    Time frame: approximately 2 years

  2. Correlation of overall survival with baseline tumour characteristics

    Time frame: approximately 2 years

  3. Correlation of overall survival with previous treatment regimens

    Time frame: approximately 2 years

Secondary outcomes

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

    Time frame: approximately 2 years

  2. Disease control rate

    Time frame: approximately 2 years

  3. Progression-free survival

    Time frame: approximately 2 years

  4. Safety: Incidence of adverse events

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multicenter, Prospective, Observational Study to Identify Different Prognostic Factors Related to Survival in Patients With Previously Treated Advanced NSCLC With Wild-type Epidermal Growth Factor Receptor (EGFR) Gene.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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