Lung Adenocarcinoma
Conditions
Brief summary
This prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.
Interventions
DRUGBevacizumab
Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab * Participant who received only 1 cycle of bevacizumab maintenance treatment * Meet summary of product characteristics guidelines
Exclusion criteria
* Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment * Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause | Baseline up to 40 months |
Secondary
| Measure | Time frame |
|---|---|
| PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause | Baseline up to 40 months |
| 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause | 12 months |
| Percentage of participants by best overall response | Baseline up to 40 months |
| Percentage of participants with adverse events | Baseline up to 40 months |
Countries
Hungary
Outcome results
None listed