ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02093000
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lung Adenocarcinoma Drug: Bevacizumab

Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 30, 2014
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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 Name: Avastin®




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause [ Time Frame: 12 months ]
  3. Percentage of participants by best overall response [ Time Frame: Baseline up to 40 months ]
  4. Percentage of participants with adverse events [ Time Frame: Baseline up to 40 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving Avastin monotherapy as maintenance treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093000


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02093000     History of Changes
Other Study ID Numbers: ML29261
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents