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NCT01990261 Clinical Trial

A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment.

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:
THE SURVIVAL OF NON SMALL CELL LUNG CARCINOMA EGFR NON-MUTATED (WILD TYPE) PATIENTS TREATED WITH ERLOTINIB (TARCEVA) AFTER THE FAILURE OF AT LEAST ONE CHEMOTHERAPY REGIMEN.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01990261
Other study ID # ML28496
Secondary ID
Status Terminated
Phase N/A
First received October 31, 2013
Last updated May 4, 2016
Start date May 2013
Est. completion date September 2014

Study information
Verified date May 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Romania: National Agency of Medicines and Medical Devices
Study type Observational

Clinical Trial Summary

This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) patients treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.

Recruitment information / eligibility
Status Terminated
Enrollment 33
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults >/= 18 years

- Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.

- At least one failed chemotherapy treatment.

Exclusion Criteria:

- Unknown EGFR mutation status

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

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy: Overall survival (OS) 12 months No
Primary Safety: Incidence of adverse events (AE) 12 months No
Secondary Efficacy: OS rate according to prior chemotherapy treatment 12 months No
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