A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351415
First received: May 9, 2011
Last updated: June 1, 2015
Last verified: June 2015
  Purpose

This open-label, randomized, multicenter study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with standard of care treatment in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with Avastin plus a platinum doublet-containing therapy and a minimum of two cycles of Avastin maintenance treatment prior to PD. Patients will be randomly assigned to one of two treatment arms to receive either Avastin plus standard of care treatment or standard of care treatment alone.


Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: Standard of care treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First (1st)-Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: June 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab [Avastin]
7.5 or 15 mg/kg intravenously on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
Drug: Standard of care treatment
Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
Active Comparator: B Drug: Standard of care treatment
Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • History of hemoptysis >/=grade 2 within 3 months of randomization
  • Major cardiac disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351415

Contacts
Contact: Reference Study ID Number: MO22097 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Completed
Mobile, Alabama, United States, 36688
United States, Arizona
Active, not recruiting
Glendale, Arizona, United States, 85304
Terminated
Glendale, Arizona, United States, 85306
United States, Arkansas
Active, not recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
Active, not recruiting
Burbank, California, United States, 91505
Completed
Encinitas, California, United States, 92008
Completed
La Jolla, California, United States, 92037-1027
Completed
Sacramento, California, United States, 95816
Terminated
San Luis Obispo, California, United States, 93401
Active, not recruiting
Whittier, California, United States, 90603
United States, Connecticut
Completed
New Britian, Connecticut, United States, 06050
Completed
Norwich, Connecticut, United States, 06360
United States, Florida
Completed
Boca Raton, Florida, United States, 33428
Completed
Jacksonville, Florida, United States, 32207
Active, not recruiting
Jacksonville, Florida, United States, 32256
Active, not recruiting
Miami Beach, Florida, United States, 33140
Active, not recruiting
Rockledge, Florida, United States, 32955
United States, Georgia
Completed
Atlanta, Georgia, United States, 30322
Terminated
Savannah, Georgia, United States, 31405
United States, Idaho
Active, not recruiting
Post Falls, Idaho, United States, 83854
United States, Illinois
Completed
Elk Grove Village, Illinois, United States, 60007
Completed
Evanston, Illinois, United States, 60201
Completed
Joliet, Illinois, United States, 60435
Completed
Niles, Illinois, United States, 60714
Completed
River Forest, Illinois, United States, 60305
United States, Indiana
Active, not recruiting
Indianapolis, Indiana, United States, 46237
Completed
Newburgh, Indiana, United States, 47630
United States, Iowa
Completed
Ames, Iowa, United States, 50010
United States, Kansas
Active, not recruiting
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
Completed
Lexington, Kentucky, United States, 40536
Active, not recruiting
Louisville, Kentucky, United States, 40245
United States, Louisiana
Terminated
Baton Rouge, Louisiana, United States, 70809
Completed
Lafayette, Louisiana, United States, 70508
United States, Maine
Active, not recruiting
Scarborough, Maine, United States, 04074
Completed
York, Maine, United States, 03909
United States, Maryland
Completed
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Completed
Boston, Massachusetts, United States, 02111
United States, Michigan
Completed
Ann Arbor, Michigan, United States, 48106
Completed
Detroit, Michigan, United States, 48202
Active, not recruiting
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Completed
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Completed
St Joseph, Missouri, United States, 64507
Completed
St. Louis, Missouri, United States, 63131
United States, New York
Completed
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Completed
Hickory, North Carolina, United States, 28602
United States, Ohio
Active, not recruiting
Canton, Ohio, United States, 44710
Active, not recruiting
Columbus, Ohio, United States, 43219
Completed
Dayton, Ohio, United States, 45420
Active, not recruiting
Middletown, Ohio, United States, 45042
Completed
Toledo, Ohio, United States, 43617
United States, Oregon
Completed
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
Completed
Bethlehem, Pennsylvania, United States, 18015
Completed
Dunmore, Pennsylvania, United States, 18512
Completed
Langhorne, Pennsylvania, United States, 19047
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19140
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Completed
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Active, not recruiting
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Completed
Knoxville, Tennessee, United States, 37920
Active, not recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Completed
Dallas, Texas, United States, 75390-9015
United States, Virginia
Active, not recruiting
Portsmouth, Virginia, United States, 23704
Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Terminated
Spokane, Washington, United States, 99208
United States, Wisconsin
Completed
Appleton, Wisconsin, United States, 54915
Completed
La Crosse, Wisconsin, United States, 54601
Completed
Madison, Wisconsin, United States, 53792
Argentina
Active, not recruiting
Buenos Aires, Argentina, C1426ANZ
Active, not recruiting
La Pampa, Argentina, 6300
Terminated
Mar Del Plata, Argentina, 7600
Completed
Rosario, Argentina, S2000DSV
Completed
Santa Fe, Argentina, 03000
Active, not recruiting
Viedma, Rio Negro, Argentina, 8500
Austria
Completed
Hohenems, Austria, 6845
Completed
Innsbruck, Austria, 6020
Completed
Natters, Austria, 6161
Active, not recruiting
Steyr, Austria, 4400
Completed
Wels, Austria, 4600
Terminated
Wien, Austria, 1090
Active, not recruiting
Wien, Austria, 1130
Completed
Wien, Austria, 1140
Belgium
Completed
Bruxelles, Belgium, 1180
Brazil
Active, not recruiting
Salvador, BA, Brazil, 40170-110
Terminated
Fortaleza, CE, Brazil, 60125-120
Completed
Brasilia, DF, Brazil, 70200-730
Active, not recruiting
Brasilia, DF, Brazil, 70390-150
Completed
Taguatinga, DF, Brazil, 72110-980
Active, not recruiting
Rio De Janeiro, RJ, Brazil, 22290-160
Active, not recruiting
Ijui, RS, Brazil, 98700-000
Terminated
Itajai, SC, Brazil, 88301-220
Terminated
Sao Paulo, SP, Brazil, 01321-001
Active, not recruiting
Sao Paulo, SP, Brazil, 01509-010
Denmark
Completed
Hillerod, Denmark, 3400
France
Completed
Aix En Provence, France, 13617
Completed
Caen, France, 14076
Not yet recruiting
Chambray Les Tours, France, 37175
Active, not recruiting
Creteil, France, 94010
Completed
Gleize, France, 69400
Completed
Lille, France, 59037
Completed
Lille, France, 59020
Completed
Lyon, France, 69394
Completed
Marseille, France, 13285
Active, not recruiting
Marseille, France, 13915
Active, not recruiting
Nice, France, 06189
Active, not recruiting
Pierre Benite, France, 69310
Active, not recruiting
Pontoise, France, 95300
Active, not recruiting
Saint Herblain, France, 44805
Completed
St-Priest-En-Jarez, France, 42271
Active, not recruiting
Strasbourg, France, 67065
Active, not recruiting
Toulon, France, 83041
Active, not recruiting
Toulon, France, 83056
Completed
Toulouse, France, 31076
Terminated
Vesoul, France, 70014
Germany
Active, not recruiting
Bad Berka, Germany, 99437
Terminated
Bergisch Gladbach, Germany, 51465
Active, not recruiting
Esslingen, Germany, 73730
Active, not recruiting
Frankfurt, Germany, 60488
Active, not recruiting
Gera, Germany, 07548
Active, not recruiting
Grosshansdorf, Germany, 22927
Completed
Halle (Saale), Germany, 06120
Terminated
Homburg/Saar, Germany, 66421
Terminated
Immenhausen, Germany, 34376
Terminated
Karlsruhe, Germany, 76137
Terminated
Leipzig, Germany, 04207
Active, not recruiting
Leipzig, Germany, 04357
Active, not recruiting
Minden, Germany, 32429
Active, not recruiting
Muenchen, Germany, 80336
Active, not recruiting
Oldenburg, Germany, 26121
Greece
Active, not recruiting
Athens, Greece, 11527
Completed
Neo Faliro, Greece, 18574
Terminated
Thessaloniki, Greece, 57001
Terminated
Thessaloniki, Greece, 570 10
Italy
Active, not recruiting
Avellino, Campania, Italy, 83100
Active, not recruiting
Napoli, Campania, Italy, 80131
Active, not recruiting
Roma, Lazio, Italy, 00128
Active, not recruiting
Roma, Lazio, Italy, 00152
Active, not recruiting
Genova, Liguria, Italy, 16132
Terminated
Saronno, Lombardia, Italy, 21047
Active, not recruiting
Pisa, Toscana, Italy, 56124
Japan
Completed
Aichi, Japan, 464-8681
Active, not recruiting
Chiba, Japan, 277-8577
Completed
Ehime, Japan, 791-0280
Completed
Fukuoka, Japan, 811-1395
Active, not recruiting
Hyogo, Japan, 673-8558
Active, not recruiting
Kanagawa, Japan, 236-0051
Active, not recruiting
Kanagawa, Japan, 240-8555
Active, not recruiting
Miyagi, Japan, 981-1293
Active, not recruiting
Okayama, Japan, 700-8558
Active, not recruiting
Osaka, Japan, 534-0021
Active, not recruiting
Osaka, Japan, 537-8511
Active, not recruiting
Shizuoka, Japan, 411-8777
Completed
Tokyo, Japan, 104-0045
Active, not recruiting
Tokyo, Japan, 135-8550
Lebanon
Terminated
Beirut, Lebanon, 11-236
Active, not recruiting
Beirut, Lebanon, 99999
Active, not recruiting
Beirut, Lebanon
Mexico
Active, not recruiting
Aguascalientes, Mexico, 20230
Completed
Mexico City, Mexico, 14140
Active, not recruiting
Mexico City, Mexico
Netherlands
Recruiting
Breda, Netherlands, 4818 CK
Active, not recruiting
Den Haag, Netherlands, 2504 LN
Recruiting
Eindhoven, Netherlands, 5623 EJ
Terminated
Harderwijk, Netherlands, 3844 DG
Active, not recruiting
Maastricht, Netherlands, 6202 AZ
Recruiting
Nieuwegein, Netherlands, 3435 CM
Oman
Terminated
Muscat, Oman, P.O Box 35
Slovakia
Completed
Banska Bystrica, Slovakia, 975 17
Completed
Bratislava, Slovakia, 826 06
Completed
Kosice, Slovakia, 04001
Recruiting
Nitra, Slovakia, 949 88
Spain
Active, not recruiting
Barakaldo, Vizcaya, Spain, 48903
Active, not recruiting
Alicante, Spain, 3010
Active, not recruiting
Madrid, Spain, 28046
Active, not recruiting
Madrid, Spain, 28040
Active, not recruiting
Madrid, Spain, 28033
Active, not recruiting
Valencia, Spain, 46010
Active, not recruiting
Valencia, Spain, 46017
Active, not recruiting
Zaragoza, Spain, 50009
United Arab Emirates
Active, not recruiting
Al Ain, United Arab Emirates, 15258
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351415     History of Changes
Other Study ID Numbers: MO22097
Study First Received: May 9, 2011
Last Updated: June 1, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015