An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01488331

Enrollment

217

Registered

2011-12-08

Start date

2010-06-30

Completion date

2013-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Brief summary

This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/=18 years of age * Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV) * Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start

Exclusion criteria

* Not agreeing to be followed-up (for a maximum of 24 months)

Design outcomes

Primary

Measure	Time frame
Progression-free survival	24 months

Secondary

Measure	Time frame
Type of treatment response	24 months
Treatment compliance of patient	24 months
Best treatment response	24 months
Overall survival	24 months
Safety (incidence of adverse events)	24 months

Countries

France

Outcome results