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

NCT ID: NCT00451906

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-06-30

Brief 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). 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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab + Chemotherapy

Participants 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.

Group Type: EXPERIMENTAL

Platinum-based chemotherapy

Intervention Type: DRUG

As prescribed

Bevacizumab [Avastin]

Intervention Type: DRUG

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

Interventions

Platinum-based chemotherapy

As prescribed

Intervention Type: DRUG

Bevacizumab [Avastin]

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Chaco-resistencia, , Argentina

Córdoba, , Argentina

Córdoba, , Argentina

San Miguel de Tucumán, , Argentina

St Leonards, New South Wales, Australia

Waratah, New South Wales, Australia

Auchenflower, Queensland, Australia

Chermside, Queensland, Australia

Tugun, Queensland, Australia

Box Hill, Victoria, Australia

Geelong, Victoria, Australia

Malvern, Victoria, Australia

Wodonga, Victoria, Australia

Perth, Western Australia, Australia

Sydney, New South Wales, , Australia

Bludesch, , Austria

Bregenz, , Austria

Feldkirch, , Austria

Graz, , Austria

Innsbruck, , Austria

Knittelfeld, , Austria

Kufstein, , Austria

Linz, , Austria

Linz, , Austria

Natters, , Austria

Salzburg, , Austria

Sankt Veit an der Glan, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vöcklabruck, , Austria

Wels, , Austria

Zams, , Austria

Banja Luka, , Bosnia and Herzegovina

Sarajevo, , Bosnia and Herzegovina

Fortaleza, Ceará, Brazil

Vitória, Espírito Santo, Brazil

Salvador, Bahia, Estado de Bahia, Brazil

Goiânia, Goiás, Brazil

Belo Horizonte, Minas Gerais, Brazil

Belo Horizonte, Minas Gerais, Brazil

Recife, Pernambuco, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Ijuí, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Campinas, São Paulo, Brazil

Campinas, São Paulo, Brazil

Jaú, São Paulo, Brazil

Ribeirão Preto, São Paulo, Brazil

Santos, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Vancouver, British Columbia, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Beijing, , China

Beijing, , China

Beijing, , China

Guangzhou, , China

Guangzhou, , China

Hangzhou, , China

Shanghai, , China

Shanghai, , China

Bogotá, , Colombia

Cali, , Colombia

Manizales, , Colombia

Brno, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Aarhus, , Denmark

Herlev, , Denmark

Hillerød, , Denmark

Næstved, , Denmark

Guayaquil, , Ecuador

Quito, , Ecuador

Cairo, , Egypt

Cairo, , Egypt

Tallinn, , Estonia

Tartu, , Estonia

Helsinki, , Finland

Paimio, , Finland

Pori, , Finland

Tampere, , Finland

Aix-en-Provence, , France

Avignon, , France

Besançon, , France

Béziers, , France

Bordeaux, , France

Brest, , France

Caen, , France

Chalon-sur-Saône, , France

Clermont-Ferrand, , France

Gap, , France

Grenoble, , France

Le Chesnay, , France

Lille, , France

Lille, , France

Lille, , France

Lyon, , France

Marseille, , France

Marseille, , France

Marseille, , France

Meaux, , France

Nancy, , France

Neuilly-sur-Seine, , France

Paris, , France

Paris, , France

Perpignan, , France

Reims, , France

Saint-Julien-en-Genevois, , France

Strasbourg, , France

Strasbourg, , France

Toulon, , France

Toulon, , France

Toulouse, , France

Toulouse, , France

Valenciennes, , France

Vandœuvre-lès-Nancy, , France

Augsburg, , Germany

Bad Berka, , Germany

Bayreuth, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bonn, , Germany

Cologne, , Germany

Coswig, , Germany

Donaustauf, , Germany

Düsseldorf, , Germany

Ebensfeld, , Germany

Erlangen, , Germany

Essen, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Gauting, , Germany

Gerlingen, , Germany

Göttingen, , Germany

Großhansdorf, , Germany

Halle, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hanover, , Germany

Hanover, , Germany

Karlsruhe, , Germany

Kiel, , Germany

Leer, , Germany

Leipzig, , Germany

Leverkusen, , Germany

Löwenstein, , Germany

Magdeburg, , Germany

Mainz, , Germany

Minden, , Germany

München, , Germany

Neuruppin, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Rostock, , Germany

Treuenbrietzen, , Germany

Ulm, , Germany

Villingen-Schwenningen, , Germany

Wiesbaden, , Germany

Wolfsburg, , Germany

Würselen, , Germany

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Shatin, , Hong Kong

Budapest, , Hungary

Mátraháza, , Hungary

Pécs, , Hungary

Szombathely, , Hungary

Törökbálint, , Hungary

Reykjavik, , Iceland

Beersheba, , Israel

Haifa, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Ẕerifin, , Israel

Avezzano, Abruzzo, Italy

Pescara, Abruzzo, Italy

Bari, Apulia, Italy

Brindisi, Apulia, Italy

San Giovanni Rotondo, Apulia, Italy

Potenza, Basilicate, Italy

Rionero in Vulture, Basilicate, Italy

Catanzaro, Calabria, Italy

Avellino, Campania, Italy

Napoli, Campania, Italy

Bologna, Emilia-Romagna, Italy

Carpi, Emilia-Romagna, Italy

Modena, Emilia-Romagna, Italy

Rimini, Emilia-Romagna, Italy

Aviano, Friuli Venezia Giulia, Italy

Udine, Friuli Venezia Giulia, Italy

Rome, Lazio, Italy

Rome, Lazio, Italy

Rome, Lazio, Italy

Sora, Lazio, Italy

Viterbo, Lazio, Italy

Genoa, Liguria, Italy

Genoa, Liguria, Italy

La Spezia, Liguria, Italy

Bergamo, Lombardy, Italy

Cremona, Lombardy, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Pavia, Lombardy, Italy

S Fermo Della Battaglia, Lombardy, Italy

Sondrio, Lombardy, Italy

Novara, Piedmont, Italy

Cagliari, Sardinia, Italy

Sassari, Sardinia, Italy

Catania, Sicily, Italy

Catania, Sicily, Italy

Palermo, Sicily, Italy

Taormina, Sicily, Italy

Ancona, The Marches, Italy

Arezzo, Tuscany, Italy

Lido di Camaiore, Tuscany, Italy

Pisa, Tuscany, Italy

Camposampiero, Veneto, Italy

Feltre - Bl, Veneto, Italy

Negrar, Veneto, Italy

Bologna, Umbria, , Italy

Forli, Emilia-Romagna, , Italy

Riga, , Latvia

Riga, , Latvia

Beirut, , Lebanon

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Chihuahua City, , Mexico

León, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Arnhem, , Netherlands

Breda, , Netherlands

Eindhoven, , Netherlands

Groningen, , Netherlands

Haarlem, , Netherlands

Helmond, , Netherlands

Hoofddorp, , Netherlands

Nieuwegein, , Netherlands

Schiedam, , Netherlands

The Hague, , Netherlands

Tiel, , Netherlands

Zwolle, , Netherlands

Bialystok, , Poland

Krakow, , Poland

Lublin, , Poland

Poznan, , Poland

Warsaw, , Poland

Warsaw, , Poland

Zabrze, , Poland

Braga, , Portugal

Coimbra, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Porto, , Portugal

Santa Maria da Feira, , Portugal

Setúbal, , Portugal

Vila Nova de Gaia, , Portugal

Bucharest, , Romania

Cluj-Napoca, , Romania

Timișoara, , Romania

Balashikha, , Russia

Engel's, , Russia

Irkutsk, , Russia

Kislino, Kursk Region, , Russia

Krasnodar, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Samara, , Russia

Smolensk, , Russia

Stavropol, , Russia

Tver', , Russia

Tyumen, , Russia

Ulyanovsk, , Russia

Belgrade, , Serbia

Bratislava, , Slovakia

Košice, , Slovakia

Nitra, , Slovakia

Poprad, , Slovakia

Golnik, , Slovenia

Ljubljana, , Slovenia

Alicante, Alicante, Spain

Elche, Alicante, Spain

Palma de Mallorca, Balearic Islands, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Manresa, Barcelona, Spain

Mataró, Barcelona, Spain

Sabadell, Barcelona, Spain

Terrassa, Barcelona, Spain

Santander, Cantabria, Spain

Girona, Girona, Spain

Huesca, Huesca, Spain

A Coruña, La Coruña, Spain

Lugo, Lugo, Spain

Alcorcón, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Murcia, Murcia, Spain

Pamplona, Navarre, Spain

Salamanca, Salamanca, Spain

San Cristóbal de La Laguna, Tenerife, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Barakaldo, Vizcaya, Spain

Zaragoza, Zaragoza, Spain

Gothenburg, , Sweden

Lund, , Sweden

Malmo, , Sweden

Örebro, , Sweden

Stokholm, Solna, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Aarau, , Switzerland

Baden, , Switzerland

Genolier, , Switzerland

Locarno, , Switzerland

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Ankara, , Turkey (Türkiye)

Gaziantep, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Sıhhiye, Ankara, , Turkey (Türkiye)

Aberdeen, , United Kingdom

Belfast, , United Kingdom

Birmingham, , United Kingdom

Cambridge, , United Kingdom

Cardiff, , United Kingdom

Manchester, , United Kingdom

Nottingham, , United Kingdom

Suffolk, , United Kingdom

Barcelona, , Venezuela

Barquisimeto, , Venezuela

Porlamar, , Venezuela

Countries

Argentina; Australia; Austria; Bosnia and Herzegovina; Brazil; Canada; China; Colombia; Czechia; Denmark; Ecuador; Egypt; Estonia; Finland; France; Germany; Hong Kong; Hungary; Iceland; Israel; Italy; Latvia; Lebanon; Lithuania; Mexico; Netherlands; Poland; Portugal; Romania; Russia; Serbia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom; Venezuela

References

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.

Reference Type: DERIVED

PMID: 23018280 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20650686 (View on PubMed)

Other Identifiers

MO19390

Identifier Type: -

Identifier Source: org_study_id