A Multicenter, Prospective, Non-interventional Study of Maintenance Avastin® (Bevacizumab) Following Induction Treatment With Platinum Doublet Plus Avastin® in Patients With Advanced Lung Adenocarcinoma

Hoffmann-La Roche16 sites in 1 country201 target enrollmentNovember 30, 2014

ConditionsLung Adenocarcinoma

InterventionsBevacizumab

DrugsBevacizumab

Overview

Phase: N/A
Intervention: Bevacizumab
Conditions: Lung Adenocarcinoma
Sponsor: Hoffmann-La Roche
Enrollment: 201
Locations: 16
Primary Endpoint: Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 30, 2014

End Date

January 31, 2018

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Bevacizumab

Participants who have received the induction phase of 4-6 cycles of bevacizumab plus platinum doublet chemotherapy will be treated with bevacizumab as maintenance treatment, according to approved label and local reimbursement.

Intervention: Bevacizumab

Outcomes

Primary Outcomes

Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause

Time Frame: Baseline up to 40 months

Secondary Outcomes

Percentage of participants with adverse events(Baseline up to 40 months)
Percentage of participants by best overall response(Baseline up to 40 months)
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)