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

Hoffmann-La Roche150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BevacizumabDRUG

Bevacizumab is prescribed by physicians as per SPC.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

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.

Time frame: up to 45 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 45 months

Data from ClinicalTrials.gov

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Ogyi, Orszagos Gyogyszereszeti Intezet

Budapest, Hungary

Szent Imre Hospital; Dept. of Oncology

Budapest, Hungary

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Hungary

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, Hungary

Semmelweis Egyetem X; Pulmonologiai Klinika

Budapest, Hungary

Uzsoki Utcai Korhaz; Ii. Belgyogyaszat

Budapest, Hungary

Debrecen Uni Medical School; Dept of Pulmonary Medicine

Debrecen, Hungary

Hajdú-Bihar Megyei Önkormányzat Kenézy Gyula Hospital; Infektology Department

Debrecen, Hungary

Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza

Deszk, Hungary

Koch Robert Korhaz

Edelény, Hungary

...and 23 more locations