An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

GERMAN TARCEVA NON-INTERVENTIONAL STUDY in 1st Line Treatment of NSCLC EGFR Mutation Positive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790217
• Other study ID #: ML27895
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer

• Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines

Exclusion Criteria:

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

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate at 18 months		3.5 years	No
Secondary	Response rate (complete response/partial response) by type of mutation		3.5 years	No
Secondary	Percentage of patients with remission		3.5 years	No
Secondary	Progression-free survival (overall/stratified)		3.5 years	No
Secondary	Overall survival (overall/stratified)		3.5 years	No
Secondary	Tolerability: Incidence of fatigue, rash, diarrhea		3.5 years	No
Secondary	Safety: Incidence of serious adverse events		3.5 years	No
Secondary	Dose modifications/withdrawals		3.5 years	No
Secondary	Symptom control (cough, dyspnea)		3.5 years	No