A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma

Completed

• Conditions: Lung Adenocarcinoma
• Interventions: Drug: Bevacizumab

• Registration Number: NCT02093000
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-20
• Study Start: 2014-11-30
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of participants by best overall response	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
PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause	Baseline up to 40 months
Percentage of participants with adverse events	Baseline up to 40 months

Trial Locations

Locations (16)

Orszagos Koranyi TBC es Pulmonologiai Intezet; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem X; Pulmonologiai Klinika; 🇭🇺 Budapest, Hungary

Uzsoki Utcai Korhaz; 🇭🇺 Budapest, Hungary

Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika; 🇭🇺 Debrecen, Hungary

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza; 🇭🇺 Deszk, Hungary

Veszprem Megyei Onkormanyzat Tudogyogyintezet; 🇭🇺 Farkasgyepu, Hungary

Petz Aladar Megyei Oktato Korhaz; 🇭🇺 Gyor, Hungary

Bekes Megyei Tudokorhaz; I. Tudobelosztaly; 🇭🇺 Gyula, Hungary

Bacs-Kiskun Megyei Korhaz; 🇭🇺 Kecskemet, Hungary

Matrai Gyogyintezet; 🇭🇺 Matrahaza, Hungary

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