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

NCT ID: NCT02093000

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Lung Adenocarcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bevacizumab

Intervention Type DRUG

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

Interventions

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Bevacizumab

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

Intervention Type DRUG

Other Intervention Names

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Avastin®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, , Hungary

Site Status

Semmelweis Egyetem X; Pulmonologiai Klinika

Budapest, , Hungary

Site Status

Uzsoki Utcai Korhaz

Budapest, , Hungary

Site Status

Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

Debrecen, , Hungary

Site Status

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

Deszk, , Hungary

Site Status

Veszprem Megyei Onkormanyzat Tudogyogyintezet

Farkasgyepű, , Hungary

Site Status

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Site Status

Bekes Megyei Tudokorhaz; I. Tudobelosztaly

Gyula, , Hungary

Site Status

Bacs-Kiskun Megyei Korhaz

Kecskemét, , Hungary

Site Status

Matrai Gyogyintezet

Mátraháza, , Hungary

Site Status

Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine

Nyíregyháza, , Hungary

Site Status

University of Pecs; 1St Department of Medicine

Pécs, , Hungary

Site Status

Fejer Megyei Szent Gyorgy Korhaz

Székesfehérvár, , Hungary

Site Status

Vas Megyei Markusovszky Korhaz ; Oncoradiology

Szombathely, , Hungary

Site Status

Komárom-Esztergom Megyei; Szent Borbála Kórháza

Tatabánya, , Hungary

Site Status

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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ML29261

Identifier Type: -

Identifier Source: org_study_id

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