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

Lung Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093000
• Other study ID #: ML29261
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: February 22, 2018
• Start date: November 30, 2014
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma
• Lung Neoplasms

Intervention

Drug:
• Bevacizumab
Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.

Locations

Country	Name	City	State
Hungary	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	Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine	Nyiregyhaza
Hungary	University of Pecs; 1St Department of Medicine	Pecs
Hungary	Fejer Megyei Szent Gyorgy Korhaz	Szekesfehervar
Hungary	Vas Megyei Markusovszky Korhaz ; Oncoradiology	Szombathely
Hungary	Komárom-Esztergom Megyei; Szent Borbála Kórháza	Tatabánya
Hungary	Tudogyogyintezet Torokbalint	Torokbalint

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause		Baseline up to 40 months
Secondary	1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause		12 months
Secondary	Percentage of participants by best overall response		Baseline up to 40 months
Secondary	Percentage of participants with adverse events		Baseline up to 40 months