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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01512420
Other study ID # ML27773
Secondary ID
Status Completed
Phase N/A
First received December 19, 2011
Last updated November 1, 2016
Start date November 2011
Est. completion date February 2015

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 355
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of overall survival with baseline clinical/demographic patient characteristics approximately 2 years No
Primary Correlation of overall survival with baseline tumour characteristics approximately 2 years No
Primary Correlation of overall survival with previous treatment regimens approximately 2 years No
Secondary Objective response rate (ORR), tumour assessments according to RECIST criteria approximately 2 years No
Secondary Disease control rate approximately 2 years No
Secondary Progression-free survival approximately 2 years No
Secondary Safety: Incidence of adverse events approximately 2 years No
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