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

February 22, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1121
        • Orszagos Koranyi TBC es Pulmonologiai Intezet
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Korhaz
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem X; Pulmonologiai Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
      • Deszk, Hungary, 6772
        • Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
      • Farkasgyepu, Hungary, 8582
        • Veszprem Megyei Onkormanyzat Tudogyogyintezet
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
      • Gyula, Hungary, 5703
        • Bekes Megyei Tudokorhaz; I. Tudobelosztaly
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz
      • Matrahaza, Hungary, 3233
        • Matrai Gyogyintezet
      • Nyiregyhaza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg County Josa Andras Hospital; 1St Depatment of Pulmonary Medicine
      • Pecs, Hungary, 7623
        • University of Pecs; 1St Department of Medicine
      • Szekesfehervar, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Korhaz
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Korhaz ; Oncoradiology
      • Tatabánya, Hungary, 2800
        • Komárom-Esztergom Megyei; Szent Borbála Kórháza
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving Avastin monotherapy as maintenance treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Bevacizumab
Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.
Other Names:
  • Avastin®

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Baseline up to 40 months
Baseline up to 40 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2014

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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