ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.

Official Title
-----------------
Observational, Post-authorization, Prospective Study for Evaluating Patterns of Disease Progression in Patients With Advanced Non-small-cell Lung Carcinoma (NSCLC) Harbouring EGFR Activating Mutations Treated With Erlotinib in First Line.

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria EGFR mutation-positive disease according to local laboratory testing Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice Exclusion Criteria: Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized >6 months prior to receiving Tarceva Participation in another clinical study Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (time from initiation of treatment to disease progression or death of any cause) in correlation with localization of progression and clinical tumor characteristics |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate, tumor assessments according to RECIST v1.1 criteria |  | 3 years | 
| One-year overall survival (from initiation of treatment to 12 months after disease progression) |  | 3 years | 
| Time to progression |  | 3 years | 
| Exposure (dosage/duration) with first-line Tarceva in clinical practice |  | 3 years | 
| Safety: Incidence of adverse events |  | 3 years | 
| Velocity of progression (disease flares) after cessation of treatment with Tarceva following disease progression |  | 3 years | 
| Treatments used after disease progression in clinical practice |  | 3 years |