AzTrials
AzTrials

Non-Squamous Non-Small Cell Lung CancerPhase 4NCT00451906

A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

A Phase 4 study testing Platinum-based chemotherapy and Bevacizumab [Avastin] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 369 sites in 40 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 single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). 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?
Platinum-based chemotherapy and Bevacizumab [Avastin]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,252 participants
Where
369 sitesin 40 countries
Study dates
Aug 2006to Jun 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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;
  • histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
  • ECOG PS status 0-2;
  • life expectancy >= 12weeks;
  • adequate renal, liver and hematological function.

Who cannot join

  • mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
  • hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
  • evidence of tumor invading major blood vessels on imaging;
  • evidence of CNS metastases, even if previously treated.
  • major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
  • prior chemotherapy for stage IIIb/IV disease.

Trial locations and contacts

369 sites in 40 countries.

369 sites in 40 countries

Italy47 sites

  • Study site

    Ancona, The Marches

  • Study site

    Arezzo, Tuscany, 52100

  • Study site

    Avellino, Campania, 83100

  • Study site

    Avezzano, Abruzzo, 67051

  • Study site

    Aviano, Friuli Venezia Giulia, 33081

  • Study site

    Bari, Apulia, 70126

  • Study site

    Bergamo, Lombardy, 24128

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Bologna, Umbria, 6132

  • Study site

    Brindisi, Apulia, 72100

  • Study site

    Cagliari, Sardinia, 09121

  • Study site

    Camposampiero, Veneto, 35012

  • Study site

    Carpi, Emilia-Romagna, 41012

  • Study site

    Catania, Sicily, 95100

  • Study site

    Catania, Sicily, 95122

  • Study site

    Catanzaro, Calabria, 88100

  • Study site

    Cremona, Lombardy, 26100

  • Study site

    Feltre - Bl, Veneto, 32032

  • Study site

    Forli, Emilia-Romagna, 47100

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Genoa, Liguria, 16149

  • Study site

    La Spezia, Liguria, 19100

  • Study site

    Lido di Camaiore, Tuscany, 55043

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Naples, Campania, 80131

  • Study site

    Negrar, Veneto, 37024

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Pescara, Abruzzo, 65100

  • Study site

    Pisa, Tuscany, 56100

  • Study site

    Potenza, Basilicate, 85100

  • Study site

    Rimini, Emilia-Romagna, 47900

  • Study site

    Rionero in Vulture, Basilicate, 85029

  • Study site

    Rome, Lazio, 00100

  • Study site

    Rome, Lazio, 00144

  • Study site

    Rome, Lazio, 00161

  • Study site

    S Fermo Della Battaglia, Lombardy, 22100

  • Study site

    San Giovanni Rotondo, Apulia, 71013

  • Study site

    Sassari, Sardinia, 07100

  • Study site

    Sondrio, Lombardy, 23100

  • Study site

    Sora, Lazio, 03039

  • Study site

    Taormina, Sicily, 98039

  • Study site

    Udine, Friuli Venezia Giulia, 33100

  • Study site

    Viterbo, Lazio, 01100

Other trials in Italy

Germany46 sites

  • Study site

    Augsburg, 86150

  • Study site

    Bad Berka, 99437

  • Study site

    Bayreuth, 95455

  • Study site

    Berlin, 12167

  • Study site

    Berlin, 12200

  • Study site

    Berlin, 13353

  • Study site

    Bielefeld, 33604

  • Study site

    Bonn, 53113

  • Study site

    Cologne, 50677

  • Study site

    Coswig, 01640

  • Study site

    Donaustauf, 93093

  • Study site

    Düsseldorf, 40225

  • Study site

    Ebensfeld, 96250

  • Study site

    Erlangen, 91054

  • Study site

    Essen, 45147

  • Study site

    Frankfurt, 60488

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Gauting, 82131

  • Study site

    Gerlingen, 70839

  • Study site

    Göttingen, 37075

  • Study site

    Großhansdorf, 22927

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 21075

  • Study site

    Hamburg, 22081

  • Study site

    Hanover, 30169

  • Study site

    Hanover, 30625

  • Study site

    Karlsruhe, 76137

  • Study site

    Kiel, 24116

  • Study site

    Leer, 26789

  • Study site

    Leipzig, 04207

  • Study site

    Leverkusen, 51375

  • Study site

    Löwenstein, 74245

  • Study site

    Magdeburg, 39120

  • Study site

    Mainz, 55131

  • Study site

    Minden, 32423

  • Study site

    München, 80336

  • Study site

    Neuruppin, 16816

  • Study site

    Nuremberg, 90419

  • Study site

    Oldenburg, 26121

  • Study site

    Rostock, 18057

  • Study site

    Treuenbrietzen, 14929

  • Study site

    Ulm, 89081

  • Study site

    Villingen-Schwenningen, 78045

  • Study site

    Wiesbaden, 65199

  • Study site

    Wolfsburg, 38440

  • Study site

    Würselen, 52146

Other trials in Germany

France35 sites

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Avignon, 84000

  • Study site

    Besançon, 75015

  • Study site

    Béziers, 34525

  • Study site

    Bordeaux, 33076

  • Study site

    Brest, 29200

  • Study site

    Caen, 14076

  • Study site

    Chalon-sur-Saône, 71100

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Gap, 5000

  • Study site

    Grenoble, 38100

  • Study site

    Le Chesnay, 33300

  • Study site

    Lille, 59020

  • Study site

    Lille, 59037

  • Study site

    Lille, 59042

  • Study site

    Lyon, 69004

  • Study site

    Marseille, 13008

  • Study site

    Marseille, 13273

  • Study site

    Marseille, 13274

  • Study site

    Meaux, 77104

  • Study site

    Nancy, 54100

  • Study site

    Neuilly-sur-Seine, 92200

  • Study site

    Paris, 75248

  • Study site

    Paris, 75571

  • Study site

    Perpignan, 66000

  • Study site

    Reims, 51100

  • Study site

    Saint-Julien-en-Genevois, 74160

  • Study site

    Strasbourg, 67085

  • Study site

    Strasbourg, 69091

  • Study site

    Toulon, 83000

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31052

  • Study site

    Toulouse, 31400

  • Study site

    Valenciennes, 59300

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain32 sites

  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Alicante, Alicante, 3010

  • Study site

    Barakaldo, Vizcaya, 48903

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08907

  • Study site

    Barcelona, Barcelona, 08916

  • Study site

    Elche, Alicante, 03202

  • Study site

    Girona, Girona, 17007

  • Study site

    Huesca, Huesca, 22004

  • Study site

    Lugo, Lugo, 27004

  • Study site

    Madrid, Madrid, 28002

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28035

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Manresa, Barcelona, 08243

  • Study site

    Mataró, Barcelona, 08304

  • Study site

    Murcia, Murcia, 30008

  • Study site

    Palma de Mallorca, Balearic Islands, 07014

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Salamanca, Salamanca, 37007

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Terrassa, Barcelona, 08221

  • Study site

    Valencia, Valencia, 41014

  • Study site

    Valencia, Valencia, 46009

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Valencia, Valencia, 46015

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Brazil27 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30110-090

  • Study site

    Belo Horizonte, Minas Gerais, 30150-320

  • Study site

    Campinas, São Paulo, 13059-900

  • Study site

    Campinas, São Paulo, 13073-400

  • Study site

    Fortaleza, Ceará, 60430-230

  • Study site

    Goiânia, Goiás, 74075-040

  • Study site

    Ijuí, Rio Grande do Sul, 98700-000

  • Study site

    Jaú, São Paulo, 17210-120

  • Study site

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Study site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Study site

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Recife, Pernambuco, 52012-220

  • Study site

    Ribeirão Preto, São Paulo, 14025-270

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20520-100

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22260-020

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22631-004

  • Study site

    Salvador, Bahia, Estado de Bahia, 40170-110

  • Study site

    Santos, São Paulo, 11075-350

  • Study site

    São Paulo, São Paulo, 01246-000

  • Study site

    São Paulo, São Paulo, 01308-505

  • Study site

    São Paulo, São Paulo, 01323-020

  • Study site

    São Paulo, São Paulo, 01323-903

  • Study site

    São Paulo, São Paulo, 01509-900

  • Study site

    São Paulo, São Paulo, 05401-400

  • Study site

    São Paulo, São Paulo, 08270-070

  • Study site

    Vitória, Espírito Santo, 29055-270

Other trials in Brazil

Austria20 sites

  • Study site

    Bludesch, 6712

  • Study site

    Bregenz, 6900

  • Study site

    Feldkirch, 6807

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Knittelfeld, 8720

  • Study site

    Kufstein, 6330

  • Study site

    Linz, 4010

  • Study site

    Linz, 4020

  • Study site

    Natters, 6161

  • Study site

    Salzburg, 5020

  • Study site

    Sankt Veit an der Glan, 9300

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

  • Study site

    Vienna, 1140

  • Study site

    Vienna, 1145

  • Study site

    Vöcklabruck, 4840

  • Study site

    Wels, 4600

  • Study site

    Zams, 6511

Other trials in Austria

Russia14 sites

  • Study site

    Balashikha, 143900

  • Study site

    Engel's, 413115

  • Study site

    Irkutsk, 664035

  • Study site

    Kislino, Kursk Region, 305035

  • Study site

    Krasnodar, 350086

  • Study site

    Moscow, 107005

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 143423

  • Study site

    Samara, 443066

  • Study site

    Smolensk, 214000

  • Study site

    Stavropol, 355047

  • Study site

    Tver', 170008

  • Study site

    Tyumen, 625047

  • Study site

    Ulyanovsk, ND

Other trials in Russia

Netherlands12 sites

  • Study site

    Arnhem, 6815 AD

  • Study site

    Breda, 4818 CK

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Groningen, 9728 NZ

  • Study site

    Haarlem, 2035 RC

  • Study site

    Helmond, 5700 AB

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Nieuwegein, 3430 CM

  • Study site

    Schiedam, 3116 BA

  • Study site

    The Hague, 2504 LN

  • Study site

    Tiel, 4002 WP

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Australia11 sites

  • Study site

    Auchenflower, Queensland, 4066

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Chermside, Queensland, 4032

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Malvern, Victoria, 3144

  • Study site

    Perth, Western Australia, 6008

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Sydney, New South Wales, 2077

  • Study site

    Tugun, Queensland, 4224

  • Study site

    Waratah, New South Wales, 2298

  • Study site

    Wodonga, Victoria, 3690

Other trials in Australia

Portugal10 sites

  • Study site

    Braga, 4719

  • Study site

    Coimbra, 55643

  • Study site

    Lisbon, 1070

  • Study site

    Lisbon, 1600

  • Study site

    Lisbon, 17769-001

  • Study site

    Porto, 4200-072

  • Study site

    Porto, 4200

  • Study site

    Santa Maria da Feira, 4520-211

  • Study site

    Setúbal, 2910-446

  • Study site

    Vila Nova de Gaia, 4400-129

Other trials in Portugal

China8 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 101149

  • Study site

    Guangzhou, 510060

  • Study site

    Guangzhou, 510080

  • Study site

    Hangzhou, 310022

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200433

Other trials in China

Israel8 sites

  • Study site

    Beersheba, 84101

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 12000

  • Study site

    Jerusalem, 91031

  • Study site

    Kfar Saba, 44281

  • Study site

    Ramat Gan, 52621

  • Study site

    Tel Aviv, 64239

  • Study site

    Tsrifin, 70300

Other trials in Israel

United Kingdom8 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Belfast, BT9 7AB

  • Study site

    Birmingham, B9 5SS

  • Study site

    Cambridge, PE3 6DA

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Manchester, M23 9LT

  • Study site

    Nottingham, NG5 1PB

  • Study site

    Suffolk, IP33 2QZ

Other trials in United Kingdom

Poland7 sites

  • Study site

    Bialystok, 15-540

  • Study site

    Krakow, 31-115

  • Study site

    Lublin, 20-950

  • Study site

    Poznan, 60-569

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-394

  • Study site

    Zabrze, 41-483

Other trials in Poland

Sweden7 sites

  • Study site

    Gothenburg, 41345

  • Study site

    Lund, 22185

  • Study site

    Malmö, 20502

  • Study site

    Örebro, 70185

  • Study site

    Stokholm, Solna, 01716

  • Study site

    Umeå, 90185

  • Study site

    Uppsala, 751 85

Other trials in Sweden

Turkey (Türkiye)6 sites

  • Study site

    Ankara, 06530

  • Study site

    Gaziantep, 27310

  • Study site

    Istanbul, 34300

  • Study site

    Istanbul, 34383

  • Study site

    Izmir, 35100

  • Study site

    Sıhhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Argentina5 sites

  • Study site

    Buenos Aires, 1272

  • Study site

    Chaco-resistencia, 3400

  • Study site

    Córdoba, 5000

  • Study site

    Córdoba, 5016

  • Study site

    San Miguel de Tucumán, T400IAK

Other trials in Argentina

Hungary5 sites

  • Study site

    Budapest, 1529

  • Study site

    Mátraháza, 3233

  • Study site

    Pécs, 7635

  • Study site

    Szombathely, 9700

  • Study site

    Törökbálint, 2045

Other trials in Hungary

Taiwan5 sites

  • Study site

    Taichung, 407

  • Study site

    Tainan, 704

  • Study site

    Taipei, 100

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Denmark4 sites

  • Study site

    Aarhus, 8000

  • Study site

    Herlev, 2730

  • Study site

    Hillerød, 3400

  • Study site

    Næstved, 4700

Other trials in Denmark

Finland4 sites

  • Study site

    Helsinki, 00290

  • Study site

    Paimio, 21540

  • Study site

    Pori, 28500

  • Study site

    Tampere, 33520

Other trials in Finland

Mexico4 sites

  • Study site

    Chihuahua City, 31000

  • Study site

    León, 37150

  • Study site

    Mexico City, 14080

  • Study site

    Mexico City, 16200

Other trials in Mexico

Slovakia4 sites

  • Study site

    Bratislava, 825 56

  • Study site

    Košice, 041 90

  • Study site

    Nitra, 949 88

  • Study site

    Poprad, 058 87

Other trials in Slovakia

Switzerland4 sites

  • Study site

    Aarau, 5000

  • Study site

    Baden, 5404

  • Study site

    Genolier, 1272

  • Study site

    Locarno, 6601

Other trials in Switzerland

Canada3 sites

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Colombia3 sites

  • Study site

    Bogotá

  • Study site

    Cali

  • Study site

    Manizales

Other trials in Colombia

Czechia3 sites

  • Study site

    Brno, 626 91

  • Study site

    Pilsen, 305 99

  • Study site

    Prague, 150 06

Other trials in Czechia

Hong Kong3 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

  • Study site

    Shatin

Other trials in Hong Kong

Lithuania3 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 5808

  • Study site

    Vilnius, 08660

Other trials in Lithuania

Romania3 sites

  • Study site

    Bucharest, 010816

  • Study site

    Cluj-Napoca, 3400

  • Study site

    Timișoara, 300223

Other trials in Romania

Venezuela3 sites

  • Study site

    Barcelona, 6001

  • Study site

    Barquisimeto, 3001

  • Study site

    Porlamar, 6301

Other trials in Venezuela

Bosnia and Herzegovina2 sites

  • Study site

    Banja Luka, 78000

  • Study site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Ecuador2 sites

  • Study site

    Guayaquil, 3623

  • Study site

    Quito, 17114965

Other trials in Ecuador

Egypt2 sites

  • Study site

    Cairo, 11737

  • Study site

    Cairo, 11796

Other trials in Egypt

Estonia2 sites

  • Study site

    Tallinn, 11619

  • Study site

    Tartu, 51003

Other trials in Estonia

Latvia2 sites

  • Study site

    Riga, LV 1079

  • Study site

    Riga, LV-1002

Other trials in Latvia

Slovenia2 sites

  • Study site

    Golnik, 4204

  • Study site

    Ljubljana, 1000

Other trials in Slovenia

Iceland1 site

  • Study site

    Reykjavik, 101

Other trials in Iceland

Lebanon1 site

  • Study site

    Beirut, 99999

Other trials in Lebanon

Serbia1 site

  • Study site

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Being tested
Platinum-based chemotherapy, Bevacizumab [Avastin]

What participants receive

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

  • Platinum-based chemotherapyDrug

    As prescribed

  • Bevacizumab [Avastin]Drug

    15 mg/kg IV on Day 1 of each 3 week cycle

Study groups in NCT00451906
Study groupRoleWhat they receive
Bevacizumab + ChemotherapyExperimentalParticipants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
Receives: Drug: Platinum-based chemotherapy; Drug: Bevacizumab [Avastin]

What is being measured

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

  1. Number of Participants With Adverse Events of Special Interest

    Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.

    Measured: Up to 3 years

  2. Number of Participants With Serious Adverse Events Related to Bevacizumab

    Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.

    Measured: Up to 3 years

Secondary outcomes (3)

  1. Duration of Overall Survival

    Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.

    Measured: Up to 3 years

  2. Time to Disease Progression

    Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

    Measured: Up to 3 years

  3. Number of Participants With Central Nervous System Bleeding

    The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.

    Measured: Up to 3 years

Timeline

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

  1. First posted26 Mar 2007 (estimated)
  2. Study startAug 2006
  3. Primary completionJun 2009
  4. Study completionJun 2009

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00451906
Sponsor's protocol ID
MO19390
Status last verified
Apr 2016
First submitted
22 Mar 2007
Last updated
24 May 2016

Publications

  • Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crino L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.

    PubMed 23018280

  • Crino L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.

    PubMed 20650686

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Platinum-based chemotherapy and Bevacizumab [Avastin] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 369 sites in 40 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 5 inclusion and 6 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 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 369 sites in Italy, Germany, France, Spain, Brazil and 35 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events of Special Interest (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 NCT00451906, which also lists 2 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 24 May 2016.

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