A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1044

Phase

  • Phase 3

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

  • Argentina
      • Bahia Blanca, Argentina, 8000
      • Buenos Aires, Argentina, C1426ANZ
      • Buenos Aires, Argentina, C1270AAE
      • Mendoza, Argentina, 5500
      • San Miguel de Tucuman, Argentina, 4000
      • Santa Fe, Argentina, 2000
      • Santa Fe, Argentina, 03000
  • Australia
      • Adelaide, Australia, 5011
      • Adelaide, Australia, 5065
      • Brisbane, Australia, 4029
      • Canberra, Australia, 2606
      • Kurralta Park, Australia, 5037
      • Melbourne, Australia, 3128
      • Parkville, Australia, 3052
      • Perth, Australia, 6009
      • Sydney, Australia, 2050
      • Sydney, Australia, 2139
      • Tugun, Australia, 4224
      • Wollongong, Australia, 2500
  • Belgium
      • Bruxelles, Belgium, 1200
      • Haine-saint-paul, Belgium, 7100
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
  • Brazil
      • Belo Horizonte, Brazil, 30150321
      • Porto Alegre, Brazil, 90020-090
      • Rio de Janeiro, Brazil, 20231-050
      • Sao Paulo, Brazil, 01221-020
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
      • Sofia, Bulgaria, 1756
      • Sofia, Bulgaria, 1527
      • Stara Zagora, Bulgaria, 8000
      • Varna, Bulgaria, 9002
      • Veliko Tarnovo, Bulgaria, 5000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
    • Ontario
      • London, Ontario, Canada, N6A 4L6
      • Mississauga, Ontario, Canada, L5M 2N1
      • Newmarket, Ontario, Canada, L3Y 2P9
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M9N 1N8
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H2L 4M1
      • Montréal, Quebec, Canada, H2W 1S6
      • Sainte-foy, Quebec, Canada, G1V 4G2
  • Czech Republic
      • Ostrava, Czech Republic, 708 52
      • Ostrava, Czech Republic, 703 84
      • Praha, Czech Republic, 180 01
      • Usti Nad Labem, Czech Republic, 401 13
  • France
      • Belfort, France, 90016
      • Bobigny, France, 93009
      • Caen, France, 14076
      • Lyon, France, 69004
      • Marseille, France, 13273
      • Montbeliard, France, 25209
      • Montpellier, France, 34295
      • Pierre Benite, France, 69495
      • Rennes, France, 35033
      • Rouen, France, 76000
      • St Herblain, France, 44805
      • Strasbourg, France, 67091
      • Vandoeuvre Les Nancy, France, 54511
  • Germany
      • Berlin, Germany, 14165
      • Essen, Germany, 45122
      • Gauting, Germany, 82131
      • Göttingen, Germany, 37075
      • Hamburg, Germany, 20246
      • Hamburg, Germany, 21075
      • Hamburg, Germany, 22045
      • Heidelberg, Germany, 69126
      • Hemer, Germany, 58675
      • Karlsruhe, Germany, 76137
      • Leverkusen, Germany, 51375
      • Mainz, Germany, 55131
      • Mannheim, Germany, 68167
      • München, Germany, 80336
  • Greece
      • Alexandroupolis, Greece, 68100
      • Athens, Greece, 11527
      • Athens, Greece, 11522
      • Thessaloniki, Greece, 57010
  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong, 852
  • Hungary
      • Budapest, Hungary, 1529
      • Mosdos, Hungary, 7257
      • Nyiregyhaza, Hungary, 4400
      • Szekesfehervar, Hungary, 8001
      • Szombathely, Hungary, 9700
      • Zalaegerszeg, Hungary, 8901
  • Israel
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49100
      • Ramat-gan, Israel, 52621
      • Tel Aviv, Israel, 6423906
  • Italy
      • Candiolo, Italy, 10060
      • Catania, Italy, 95123
      • Genova, Italy, 16132
      • Milano, Italy, 20162
      • Milano, Italy, 20133
      • Napoli, Italy, 80131
      • Parma, Italy, 43100
      • Perugia, Italy, 06132
      • Reggio Emilia, Italy, 42100
      • Roma, Italy, 00168
      • Roma, Italy, 00152
      • Rozzano, Italy, 20089
  • Poland
      • Gdansk, Poland, 80-214
      • Gdynia, Poland, 81-519
      • Lublin, Poland, 20-950
      • Olsztyn, Poland, 10-228
      • Poznan, Poland, 60-569
      • Szczecin, Poland, 70-891
      • Warszawa, Poland, 02-781
  • Russian Federation
      • Balashikha, Russian Federation, 143900
      • Moscow, Russian Federation, 105229
      • Moscow, Russian Federation, 107005
      • Moscow, Russian Federation, 123098
      • Moscow, Russian Federation, 115478
      • Moscow, Russian Federation, 143423
      • St Petersburg, Russian Federation, 197758
      • St Petersburg, Russian Federation, 198255
      • St Petersburg, Russian Federation, 197089
  • Spain
      • Alicante, Spain, 03010
      • Barakaldo, Spain, 48903
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08907
      • Girona, Spain, 17007
      • La Laguna, Spain, 38320
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Madrid, Spain, 28222
      • Málaga, Spain, 29010
      • Sevilla, Spain, 41014
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46010
      • Valencia, Spain, 46009
      • Valencia, Spain, 41014
      • Valencia, Spain, 46015
  • Taiwan
      • Kueishan, Taiwan, 333
      • Taichung, Taiwan, 404
      • Taichung, Taiwan, 407
      • Taipei, Taiwan
      • Taipei, Taiwan, 105
  • Thailand
      • Bangkok, Thailand, 10400
      • Chiang Mai, Thailand, 50200
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
      • London, United Kingdom, N18 1QX
      • Manchester, United Kingdom, M2O 4BX
      • Sheffield, United Kingdom, S10 2SJ
      • Sutton, United Kingdom, SM2 5PT
      • Yeovil, United Kingdom, BA21 4AT

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

Description

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
  • adequate liver and kidney function;
  • women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

  • prior chemotherapy or treatment with another systemic cancer therapy;
  • surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
  • brain metastasis or spinal cord compression;
  • fertile men, and women of childbearing potential, not using adequate contraception;
  • treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
EXPERIMENTAL: 2
Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: bevacizumab [Avastin]
15mg/kg 1v on day 1 of each 3 week cycle until disease progression
Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
PLACEBO_COMPARATOR: 3
Drug: Cisplatin
80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
Drug: Gemcitabine
1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
Drug: Placebo
iv on day 1 of each 3 week cycle until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Event driven
Event driven

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
Time Frame: Event driven
Event driven
Safety:AEs, laboratory tests, SAEs, coagulation parameters
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2005

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (ESTIMATE)

December 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO17704

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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