NCT02093000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

March 19, 2014

Last Update Submit

February 22, 2018

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Percentage of participants by best overall response

    Baseline up to 40 months

  • Percentage of participants with adverse events

    Baseline up to 40 months

Study Arms (1)

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

Interventions

BevacizumabDRUG

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

Also known as: Avastin®
Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving Avastin monotherapy as maintenance treatment

You may qualify if:

  • 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

You may not qualify if:

  • Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
  • Pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, 1121, Hungary

Location

Semmelweis Egyetem X; Pulmonologiai Klinika

Budapest, 1125, Hungary

Location

Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Location

Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

Debrecen, 4032, Hungary

Location

Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

Deszk, 6772, Hungary

Location

Veszprem Megyei Onkormanyzat Tudogyogyintezet

Farkasgyepű, 8582, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Bekes Megyei Tudokorhaz; I. Tudobelosztaly

Gyula, 5703, Hungary

Location

Bacs-Kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Matrai Gyogyintezet

Mátraháza, 3233, Hungary

Location

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

Nyíregyháza, 4400, Hungary

Location

University of Pecs; 1St Department of Medicine

Pécs, 7623, Hungary

Location

Fejer Megyei Szent Gyorgy Korhaz

Székesfehérvár, 8000, Hungary

Location

Vas Megyei Markusovszky Korhaz ; Oncoradiology

Szombathely, 9700, Hungary

Location

Komárom-Esztergom Megyei; Szent Borbála Kórháza

Tatabánya, 2800, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, 2045, Hungary

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 20, 2014

Study Start

November 30, 2014

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

HU(16)