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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488331
• Other study ID #: ML22973
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: November 1, 2016
• Start date: June 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		24 months	No
Secondary	Best treatment response		24 months	No
Secondary	Overall survival		24 months	No
Secondary	Safety (incidence of adverse events)		24 months	No
Secondary	Type of treatment response		24 months	No
Secondary	Treatment compliance of patient		24 months	No