Observational Study to Evalute the Efficacy and Safety of Avastin (Bevacizumab) in Addition to Platinum-Based Chemotherapy for First-Line Treatment of Participants With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy of Bevacizumab in addition to platinum-based chemotherapy for first-line treatment of participants with advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.

Official Title
-----------------
A Multi-Center Observational Survey of the Efficacy and Safety of Avastin in Addition to Platimun-Based Chemotherapy for First-Line Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In accordance with the SPC. Most important criteria: Histology or cytology proven inoperable, locally advanced,metastatic or recurrent (stage IIIB/IV) NSCLC other than predominantly squamous cell histology First-line treatment is indicated No previous treatment with Bevacizumab Exclusion Criteria: In accordance with the SPC. Most important criteria: Hypersensitivity to the active ingredient or to any of the excipients Hypersensitivity to products derived from Chinese hamster ovary (CHO) cells or to other recombinant human or humanized antibodies Pregnancy Bevacizumab is contraindicated in the presence of untreated central nervous system metastases

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 |
| --- | --- |
| Bevacizumab<br>Participants with advanced (stage IIIB/IV) NSCLC other than predominantly squamous cell histology receiving Bevacizumab in accordance with the summary product characteristics (SPC) is observed. | Drug: Bevacizumab<br>* Bevacizumab is prescribed by physicians as per SPC.<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression | Time to progression is the time elapsed from the date of enrollment to the first documented progression or to death of any cause. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time. | up to 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Tumor Response | Best tumor response is evaluated as percentage of participants with complete remission (CR), partial response (PR), stable disease (SD) and progressive disease. | Up to 45 months | 
| Overall Survival | Overall survival is the time elapsed between enrollment and death of any cause. For participants who don't die until the end of treatment, the overall survival data will be analyzed retrospectively based on their date of death after the end of study. | Up to 45 months | 
| Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to 45 months |