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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Correlation of overall survival with baseline clinical/demographic patient characteristics

Outcome Time Frame:

approximately 2 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

Study ID:

ML27773

NCT ID:

NCT01512420

Start Date:

November 2011

Completion Date:

February 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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