AzTrials
AzTrials

Non-Squamous Non-Small Cell Lung CancerPhase 3NCT00806923

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

A Phase 3 study testing Cisplatin, Gemcitabine and bevacizumab [Avastin] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 154 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
Cisplatin, Gemcitabine and bevacizumab [Avastin]
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,044 participants
Where
154 sitesin 20 countries
Study dates
Feb 2005to Feb 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

154 sites in 20 countries.

154 sites in 20 countries

Spain18 sites

  • Study site

    Alicante, 03010

  • Study site

    Barakaldo, 48903

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08907

  • Study site

    Girona, 17007

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28222

  • Study site

    Málaga, 29010

  • Study site

    San Cristóbal de La Laguna, 38320

  • Study site

    Seville, 41013

  • Study site

    Seville, 41014

  • Study site

    Valencia, 41014

  • Study site

    Valencia, 46009

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46015

Other trials in Spain

Canada14 sites

  • Study site

    Calgary, Alberta, T2N 4N2

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Mississauga, Ontario, L5M 2N1

  • Study site

    Moncton, New Brunswick, E1C 8X3

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H2W 1S6

  • Study site

    Newmarket, Ontario, L3Y 2P9

  • Study site

    Sainte-Foy, Quebec, G1V 4G2

  • Study site

    Toronto, Ontario, M5G 1X5

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Toronto, Ontario, M9N 1N8

  • Study site

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Germany14 sites

  • Study site

    Berlin, 14165

  • Study site

    Essen, 45122

  • Study site

    Gauting, 82131

  • Study site

    Göttingen, 37075

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 21075

  • Study site

    Hamburg, 22045

  • Study site

    Heidelberg, 69126

  • Study site

    Hemer, 58675

  • Study site

    Karlsruhe, 76137

  • Study site

    Leverkusen, 51375

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68167

  • Study site

    München, 80336

Other trials in Germany

France13 sites

  • Study site

    Belfort, 90016

  • Study site

    Bobigny, 93009

  • Study site

    Caen, 14076

  • Study site

    Lyon, 69004

  • Study site

    Marseille, 13273

  • Study site

    Montbéliard, 25209

  • Study site

    Montpellier, 34295

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76000

  • Study site

    Saint-Herblain, 44805

  • Study site

    Strasbourg, 67091

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia12 sites

  • Study site

    Adelaide, 5011

  • Study site

    Adelaide, 5065

  • Study site

    Brisbane, 4029

  • Study site

    Canberra, 2606

  • Study site

    Kurralta Park, 5037

  • Study site

    Melbourne, 3128

  • Study site

    Parkville, 3052

  • Study site

    Perth, 6009

  • Study site

    Sydney, 2050

  • Study site

    Sydney, 2139

  • Study site

    Tugun, 4224

  • Study site

    Wollongong, 2500

Other trials in Australia

Italy12 sites

  • Study site

    Candiolo, 10060

  • Study site

    Catania, 95123

  • Study site

    Genova, 16132

  • Study site

    Milan, 20133

  • Study site

    Milan, 20162

  • Study site

    Naples, 80131

  • Study site

    Parma, 43100

  • Study site

    Perugia, 06132

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00152

  • Study site

    Roma, 00168

  • Study site

    Rozzano, 20089

Other trials in Italy

Russia9 sites

  • Study site

    Balashikha, 143900

  • Study site

    Moscow, 105229

  • Study site

    Moscow, 107005

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 123098

  • Study site

    Moscow, 143423

  • Study site

    Saint Petersburg, 197089

  • Study site

    Saint Petersburg, 197758

  • Study site

    Saint Petersburg, 198255

Other trials in Russia

Argentina7 sites

  • Study site

    Bahía Blanca, 8000

  • Study site

    Buenos Aires, C1270AAE

  • Study site

    Buenos Aires, C1426ANZ

  • Study site

    Mendoza, 5500

  • Study site

    San Miguel de Tucumán, 4000

  • Study site

    Santa Fe, 03000

  • Study site

    Santa Fe, 2000

Other trials in Argentina

Poland7 sites

  • Study site

    Gdansk, 80-214

  • Study site

    Gdynia, 81-519

  • Study site

    Lublin, 20-950

  • Study site

    Olsztyn, 10-228

  • Study site

    Poznan, 60-569

  • Study site

    Szczecin, 70-891

  • Study site

    Warsaw, 02-781

Other trials in Poland

Bulgaria6 sites

  • Study site

    Plovdiv, 4004

  • Study site

    Sofia, 1527

  • Study site

    Sofia, 1756

  • Study site

    Stara Zagora, 8000

  • Study site

    Varna, 9002

  • Study site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Hungary6 sites

  • Study site

    Budapest, 1529

  • Study site

    Mosdós, 7257

  • Study site

    Nyíregyháza, 4400

  • Study site

    Székesfehérvár, 8001

  • Study site

    Szombathely, 9700

  • Study site

    Zalaegerszeg, 8901

Other trials in Hungary

United Kingdom6 sites

  • Study site

    Guildford, GU2 7XX

  • Study site

    London, N18 1QX

  • Study site

    Manchester, M2O 4BX

  • Study site

    Sheffield, S10 2SJ

  • Study site

    Sutton, SM2 5PT

  • Study site

    Yeovil, BA21 4AT

Other trials in United Kingdom

Israel5 sites

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49100

  • Study site

    Ramat Gan, 52621

  • Study site

    Tel Aviv, 6423906

Other trials in Israel

Taiwan5 sites

  • Study site

    Kueishan, 333

  • Study site

    Taichung, 404

  • Study site

    Taichung, 407

  • Study site

    Taipei, 105

  • Study site

    Taipei

Other trials in Taiwan

Belgium4 sites

  • Study site

    Brussels, 1200

  • Study site

    Haine-Saint-Paul, 7100

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Brazil4 sites

  • Study site

    Belo Horizonte, 30150321

  • Study site

    Porto Alegre, 90020-090

  • Study site

    Rio de Janeiro, 20231-050

  • Study site

    São Paulo, 01221-020

Other trials in Brazil

Czechia4 sites

  • Study site

    Ostrava, 703 84

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 180 01

  • Study site

    Ústí nad Labem, 401 13

Other trials in Czechia

Greece4 sites

  • Study site

    Alexandroupoli, 68100

  • Study site

    Athens, 11522

  • Study site

    Athens, 11527

  • Study site

    Thessaloniki, 57010

Other trials in Greece

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in Hong Kong

Thailand2 sites

  • Study site

    Bangkok, 10400

  • Study site

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: 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.

Being tested
Cisplatin, Gemcitabine, Placebo, bevacizumab [Avastin]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles

  • GemcitabineDrug

    1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles

  • PlaceboDrug

    iv on day 1 of each 3 week cycle until disease progression

  • bevacizumab [Avastin]Drug

    15mg/kg 1v on day 1 of each 3 week cycle until disease progression

  • bevacizumab [Avastin]Drug

    7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression

Study groups in NCT00806923
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: bevacizumab [Avastin]
2ExperimentalNot described
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: bevacizumab [Avastin]
3Placebo comparatorNot described
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: Event driven

Secondary outcomes (2)

  1. Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.

    Measured: Event driven

  2. Safety:AEs, laboratory tests, SAEs, coagulation parameters

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2008 (estimated)
  2. Study startFeb 2005
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00806923
Sponsor's protocol ID
BO17704
Status last verified
Nov 2016
First submitted
10 Dec 2008
Last updated
2 Nov 2016
Results posted
No

Publications

  • Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

    PubMed 21245868

  • Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.

    PubMed 20978447

  • Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.

    PubMed 20150572

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Gemcitabine and bevacizumab [Avastin] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 154 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in Spain, Canada, Germany, France, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Event driven). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806923, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in