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

Hoffmann-La Roche52 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * N/A

Locations (1)

Unnamed facility

Oldenburg, Germany

Outcomes

Primary Outcomes

Progression-free survival rate at 18 months

Time frame: 3.5 years

Secondary Outcomes

Response rate (complete response/partial response) by type of mutation

Time frame: 3.5 years

Percentage of patients with remission

Time frame: 3.5 years

Progression-free survival (overall/stratified)

Time frame: 3.5 years

Overall survival (overall/stratified)

Time frame: 3.5 years

Tolerability: Incidence of fatigue, rash, diarrhea

Time frame: 3.5 years

Safety: Incidence of serious adverse events

Time frame: 3.5 years

Dose modifications/withdrawals

Time frame: 3.5 years

Symptom control (cough, dyspnea)

Time frame: 3.5 years

Data from ClinicalTrials.gov

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