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A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351415
First received: May 9, 2011
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Bevacizumab
Drug: Docetaxel
Drug: Erlotinib
Drug: Pemetrexed
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 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 (OS) Duration [ Time Frame: Baseline until death (up to approximately 5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Objective Response According to RECIST v1.1 [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Disease Control According to RECIST v1.1 [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Duration of Response (DoR) According to RECIST v1.1 [ Time Frame: Baseline up to PD or death, whichever occurs first (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 5 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) According to RECIST v1.1 [ Time Frame: Baseline up to PD (up to approximately 5 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Are Alive at Month 6, 12, and 18 [ Time Frame: Month 6, Month 12, Month 18 ] [ Designated as safety issue: No ]

Enrollment: 487
Study Start Date: June 2011
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + Standard of Care
Participants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Drug: Bevacizumab
Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
Other Name: Avastin
Drug: Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.
Drug: Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Drug: Pemetrexed
Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.
Active Comparator: Standard of Care
Participants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Drug: Docetaxel
Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.
Drug: Erlotinib
Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
Drug: Pemetrexed
Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-squamous NSCLC
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Bevacizumab 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 v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants with adequate hematological, liver, and renal function
  • Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
  • History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
  • History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
  • Major cardiac disease
  • Treatment with any other investigational agent within 28 days prior to randomization
  • Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
  • Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
  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

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
Glendale, Arizona, United States, 85304
Glendale, Arizona, United States, 85306
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Burbank, California, United States, 91505
Encinitas, California, United States, 92008
La Jolla, California, United States, 92037-1027
Sacramento, California, United States, 95816
San Luis Obispo, California, United States, 93401
Whittier, California, United States, 90603
United States, Connecticut
New Britian, Connecticut, United States, 06050
Norwich, Connecticut, United States, 06360
United States, Florida
Boca Raton, Florida, United States, 33428
Jacksonville, Florida, United States, 32207
Jacksonville, Florida, United States, 32256
Miami Beach, Florida, United States, 33140
Rockledge, Florida, United States, 32955
United States, Georgia
Atlanta, Georgia, United States, 30322
Savannah, Georgia, United States, 31405
United States, Idaho
Post Falls, Idaho, United States, 83854
United States, Illinois
Elk Grove Village, Illinois, United States, 60007
Evanston, Illinois, United States, 60201
Joliet, Illinois, United States, 60435
Niles, Illinois, United States, 60714
River Forest, Illinois, United States, 60305
United States, Indiana
Indianapolis, Indiana, United States, 46237
Newburgh, Indiana, United States, 47630
United States, Iowa
Ames, Iowa, United States, 50010
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Kentucky
Lexington, Kentucky, United States, 40536
Louisville, Kentucky, United States, 40245
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
Lafayette, Louisiana, United States, 70508
United States, Maine
Scarborough, Maine, United States, 04074
York, Maine, United States, 03909
United States, Maryland
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Ann Arbor, Michigan, United States, 48106
Detroit, Michigan, United States, 48202
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
St Joseph, Missouri, United States, 64507
St. Louis, Missouri, United States, 63131
United States, New York
Stony Brook, New York, United States, 11794-9447
United States, North Carolina
Hickory, North Carolina, United States, 28602
United States, Ohio
Canton, Ohio, United States, 44710
Columbus, Ohio, United States, 43219
Dayton, Ohio, United States, 45420
Middletown, Ohio, United States, 45042
Toledo, Ohio, United States, 43617
United States, Oregon
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Dunmore, Pennsylvania, United States, 18512
Langhorne, Pennsylvania, United States, 19047
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19140
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Germantown, Tennessee, United States, 38138
Knoxville, Tennessee, United States, 37920
United States, Texas
Dallas, Texas, United States, 75390-9015
United States, Virginia
Portsmouth, Virginia, United States, 23704
Roanoke, Virginia, United States, 24014
United States, Washington
Spokane, Washington, United States, 99208
United States, Wisconsin
Appleton, Wisconsin, United States, 54915
La Crosse, Wisconsin, United States, 54601
Madison, Wisconsin, United States, 53792
Argentina
Buenos Aires, Argentina, C1426ANZ
La Pampa, Argentina, 6300
Mar Del Plata, Argentina, 7600
Rosario, Argentina, S2000DSV
Santa Fe, Argentina, 03000
Viedma, Rio Negro, Argentina, 8500
Austria
Hohenems, Austria, 6845
Innsbruck, Austria, 6020
Natters, Austria, 6161
Steyr, Austria, 4400
Wels, Austria, 4600
Wien, Austria, 1090
Wien, Austria, 1130
Wien, Austria, 1140
Belgium
Bruxelles, Belgium, 1180
Brazil
Salvador, Bahia, BA, Brazil, 40170-380
Fortaleza, CE, Brazil, 60125-120
Brasilia, DF, Brazil, 70200-730
Brasilia, DF, Brazil, 70390-150
Taguatinga, DF, Brazil, 72110-980
Rio De Janeiro, RJ, Brazil, 22290-160
Ijui, RS, Brazil, 98700-000
Itajai, SC, Brazil, 88301-220
Sao Paulo, SP, Brazil, 01509-010
São Paulo, SP, Brazil, CEP 01321-001
Denmark
Hillerod, Denmark, 3400
France
Aix En Provence, France, 13617
Caen, France, 14076
Chambray Les Tours, France, 37175
Creteil, France, 94010
Gleize, France, 69400
Lille, France, 59020
Lille, France, 59037
Lyon, France, 69394
Marseille, France, 13285
Marseille, France, 13915
Nice, France, 06189
Pierre Benite, France, 69310
Pontoise, France, 95300
Saint Herblain, France, 44805
St-Priest-En-Jarez, France, 42271
Strasbourg, France, 67065
Toulon, France, 83041
Toulon, France, 83056
Toulouse, France, 31076
Vesoul, France, 70014
Germany
Bad Berka, Germany, 99437
Bergisch Gladbach, Germany, 51465
Esslingen, Germany, 73730
Frankfurt, Germany, 60488
Gera, Germany, 07548
Grosshansdorf, Germany, 22927
Halle (Saale), Germany, 06120
Homburg/Saar, Germany, 66421
Immenhausen, Germany, 34376
Karlsruhe, Germany, 76137
Leipzig, Germany, 04207
Leipzig, Germany, 04357
Minden, Germany, 32429
Muenchen, Germany, 80336
Oldenburg, Germany, 26121
Greece
Athens, Greece, 11527
Neo Faliro, Greece, 18574
Thessaloniki, Greece, 570 10
Thessaloniki, Greece, 57001
Italy
Avellino, Campania, Italy, 83100
Napoli, Campania, Italy, 80131
Roma, Lazio, Italy, 00128
Roma, Lazio, Italy, 00152
Genova, Liguria, Italy, 16132
Saronno, Lombardia, Italy, 21047
Pisa, Toscana, Italy, 56124
Japan
Aichi, Japan, 464-8681
Chiba, Japan, 277-8577
Ehime, Japan, 791-0280
Fukuoka, Japan, 811-1395
Hyogo, Japan, 673-8553
Kanagawa, Japan, 236-0051
Kanagawa, Japan, 240-8555
Miyagi, Japan, 981-1293
Okayama, Japan, 700-8558
Osaka, Japan, 534-0021
Osaka, Japan, 537-8511
Shizuoka, Japan, 411-8777
Tokyo, Japan, 104-0045
Tokyo, Japan, 135-8550
Lebanon
Beirut, Lebanon, 11-236
Beirut, Lebanon, 99999
Beirut, Lebanon
Mexico
Aguascalientes, Mexico, 20230
Mexico City, Mexico, 14140
Mexico City, Mexico
Netherlands
Breda, Netherlands, 4818 CK
Den Haag, Netherlands, 2504 LN
Eindhoven, Netherlands, 5623 EJ
Harderwijk, Netherlands, 3844 DG
Maastricht, Netherlands, 6202 AZ
Nieuwegein, Netherlands, 3435 CM
Oman
Muscat, Oman, P.O Box 35
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 826 06
Kosice, Slovakia, 04001
Nitra, Slovakia, 949 88
Spain
Barakaldo, Vizcaya, Spain, 48903
Alicante, Spain, 3010
Madrid, Spain, 28033
Madrid, Spain, 28040
Madrid, Spain, 28046
Valencia, Spain, 46010
Valencia, Spain, 46017
Zaragoza, Spain, 50009
United Arab Emirates
Al Ain, United Arab Emirates, 15258
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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  2010-022645-14 
Study First Received: May 9, 2011
Last Updated: September 15, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Docetaxel
Pemetrexed
Erlotinib Hydrochloride
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 26, 2016