Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
DRUGBevacizumab
Bevacizumab is prescribed by physicians as per SPC.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression | up to 45 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Tumor Response | Up to 45 months | Best tumor response is evaluated as percentage of participants with complete remission (CR), partial response (PR), stable disease (SD) and progressive disease. |
| Overall Survival | Up to 45 months | 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. |
| Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) | Up to 45 months | 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. |
Countries
Hungary
Outcome results
None listed