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

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.

Study Overview

• Status: Completed
• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Platinum-based chemotherapy; Drug: Bevacizumab [Avastin]

• Study Type: Interventional
• Enrollment (Actual): 2252
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1272
  • Chaco-resistencia, Argentina, 3400
  • Cordoba, Argentina, 5000
  • Córdoba, Argentina, 5016
  • Tucuman, Argentina, T400IAK
• Australia
  • Sydney, New South Wales, Australia, 2077
  • New South Wales
    • St. Leonards, New South Wales, Australia, 2065
    • Waratah, New South Wales, Australia, 2298
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
    • Chermside, Queensland, Australia, 4032
    • Tugun, Queensland, Australia, 4224
  • Victoria
    • Box Hill, Victoria, Australia, 3128
    • Geelong, Victoria, Australia, 3220
    • Malvern, Victoria, Australia, 3144
    • Wodonga, Victoria, Australia, 3690
  • Western Australia
    • Perth, Western Australia, Australia, 6008
• Austria
  • Bludesch, Austria, 6712
  • Bregenz, Austria, 6900
  • Feldkirch, Austria, 6807
  • Graz, Austria, 8036
  • Innsbruck, Austria, 6020
  • Knittelfeld, Austria, 8720
  • Kufstein, Austria, 6330
  • Linz, Austria, 4020
  • Linz, Austria, 4010
  • Natters, Austria, 6161
  • Salzburg, Austria, 5020
  • St Veit An Der Glan, Austria, 9300
  • Vöcklabruck, Austria, 4840
  • Wels, Austria, 4600
  • Wien, Austria, 1030
  • Wien, Austria, 1130
  • Wien, Austria, 1090
  • Wien, Austria, 1140
  • Wien, Austria, 1145
  • Zams, Austria, 6511
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
  • Sarajevo, Bosnia and Herzegovina, 71000
• Brazil
  • BA
    • Salvador, Bahia, BA, Brazil, 40170-110
  • CE
    • Fortaleza, CE, Brazil, 60430-230
  • ES
    • Vitoria, ES, Brazil, 29055-270
  • GO
    • Goiania, GO, Brazil, 74075-040
  • MG
    • Belo Horizonte, MG, Brazil, 30110-090
    • Belo Horizonte, MG, Brazil, 30150-320
  • PE
    • Recife, PE, Brazil, 52012-220
  • RJ
    • Rio De Janeiro, RJ, Brazil, 20520-100
    • Rio de Janeiro, RJ, Brazil, 22260-020
    • Rio de Janeiro, RJ, Brazil, 22631-004
  • RS
    • Ijui, RS, Brazil, 98700-000
    • Porto Alegre, RS, Brazil, 90430-090
    • Porto Alegre, RS, Brazil, 90050-170
    • Porto Alegre, RS, Brazil, 90110-270
    • Porto Alegre, RS, Brazil, 90610-000
  • SP
    • Campinas, SP, Brazil, 13059-900
    • Campinas, SP, Brazil, 13073-400
    • Jau, SP, Brazil, 17210-120
    • Ribeirao Preto, SP, Brazil, 14025-270
    • Santos, SP, Brazil, 11075-350
    • Sao Paulo, SP, Brazil, 01246-000
    • Sao Paulo, SP, Brazil, 01308-505
    • Sao Paulo, SP, Brazil, 01323-020
    • Sao Paulo, SP, Brazil, 01323-903
    • Sao Paulo, SP, Brazil, 01509-900
    • Sao Paulo, SP, Brazil, 05401-400
    • Sao Paulo, SP, Brazil, 08270-070
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
    • Montreal, Quebec, Canada, H2L 4M1
• China
  • Beijing, China, 100730
  • Beijing, China, 100021
  • Beijing, China, 101149
  • Guangzhou, China, 510060
  • Guangzhou, China, 510080
  • Hangzhou, China, 310022
  • Shanghai, China, 200032
  • Shanghai, China, 200433
• Colombia
  • Bogota, Colombia
  • Cali, Colombia
  • Manizales, Colombia
• Czech Republic
  • Brno, Czech Republic, 626 91
  • Plzen, Czech Republic, 305 99
  • Praha, Czech Republic, 150 06
• Denmark
  • Herlev, Denmark, 2730
  • Hillerod, Denmark, 3400
  • Naestved, Denmark, 4700
  • Århus, Denmark, 8000
• Ecuador
  • Guayaquil, Ecuador, 3623
  • Quito, Ecuador, 17114965
• Egypt
  • Cairo, Egypt, 11737
  • Cairo, Egypt, 11796
• Estonia
  • Tallinn, Estonia, 11619
  • Tartu, Estonia, 51003
• Finland
  • Helsinki, Finland, 00290
  • Paimio, Finland, 21540
  • Pori, Finland, 28500
  • Tampere, Finland, 33520
• France
  • Aix En Provence, France, 13616
  • Avignon, France, 84000
  • Besancon, France, 75015
  • Beziers, France, 34525
  • Bordeaux, France, 33076
  • Brest, France, 29200
  • Caen, France, 14076
  • Chalon Sur Saone, France, 71100
  • Clermont-ferrand, France, 63003
  • GAP, France, 5000
  • Grenoble, France, 38100
  • Le Chesnay, France, 33300
  • Lille, France, 59037
  • Lille, France, 59042
  • Lille, France, 59020
  • Lyon, France, 69004
  • Marseille, France, 13274
  • Marseille, France, 13008
  • Marseille, France, 13273
  • Meaux, France, 77104
  • Nancy, France, 54100
  • Neuilly Sur Seine, France, 92200
  • Paris, France, 75248
  • Paris, France, 75571
  • Perpignan, France, 66000
  • Reims, France, 51100
  • St Julien En Genevois, France, 74160
  • Strasbourg, France, 67085
  • Strasbourg, France, 69091
  • Toulon, France, 83056
  • Toulon, France, 83000
  • Toulouse, France, 31052
  • Toulouse, France, 31400
  • Valenciennes, France, 59300
  • Vandoeuvre Les Nancy, France, 54511
• Germany
  • Augsburg, Germany, 86150
  • Bad Berka, Germany, 99437
  • Bayreuth, Germany, 95455
  • Berlin, Germany, 12200
  • Berlin, Germany, 13353
  • Berlin, Germany, 12167
  • Bielefeld, Germany, 33604
  • Bonn, Germany, 53113
  • Coswig, Germany, 01640
  • Donaustauf, Germany, 93093
  • Düsseldorf, Germany, 40225
  • Ebensfeld, Germany, 96250
  • Erlangen, Germany, 91054
  • Essen, Germany, 45147
  • Frankfurt, Germany, 60488
  • Freiburg, Germany, 79106
  • Gauting, Germany, 82131
  • Gerlingen, Germany, 70839
  • Grosshansdorf, Germany, 22927
  • Göttingen, Germany, 37075
  • Halle (Saale), Germany, 06120
  • Hamburg, Germany, 22081
  • Hamburg, Germany, 21075
  • Hannover, Germany, 30625
  • Hannover, Germany, 30169
  • Karlsruhe, Germany, 76137
  • Kiel, Germany, 24116
  • Köln, Germany, 50677
  • Leer, Germany, 26789
  • Leipzig, Germany, 04207
  • Leverkusen, Germany, 51375
  • Löwenstein, Germany, 74245
  • Magdeburg, Germany, 39120
  • Mainz, Germany, 55131
  • Minden, Germany, 32423
  • Muenchen, Germany, 80336
  • Neuruppin, Germany, 16816
  • Nürnberg, Germany, 90419
  • Oldenburg, Germany, 26121
  • Rostock, Germany, 18057
  • Treuenbrietzen, Germany, 14929
  • Ulm, Germany, 89081
  • Villingen-Schwenningen, Germany, 78045
  • Wiesbaden, Germany, 65199
  • Wolfsburg, Germany, 38440
  • Wuerselen, Germany, 52146
• Hong Kong
  • Hong Kong, Hong Kong
  • Hong Kong, Hong Kong, 852
  • Shatin, Hong Kong
• Hungary
  • Budapest, Hungary, 1529
  • Mátraháza, Hungary, 3233
  • Pecs, Hungary, 7635
  • Szombathely, Hungary, 9700
  • Torokbalint, Hungary, 2045
• Iceland
  • Reykjavik, Iceland, 101
• Israel
  • Beer Sheva, Israel, 84101
  • Haifa, Israel, 31096
  • Jerusalem, Israel, 91031
  • Jerusalem, Israel, 12000
  • Kfar-Saba, Israel, 44281
  • Ramat Gan, Israel, 52621
  • Tel Aviv, Israel, 64239
  • Zerifin, Israel, 70300
• Italy
  • Bologna, Umbria, Italy, 6132
  • Forli, Emilia-Romagna, Italy, 47100
  • Abruzzo
    • Avezzano, Abruzzo, Italy, 67051
    • Pescara, Abruzzo, Italy, 65100
  • Basilicata
    • Potenza, Basilicata, Italy, 85100
    • Rionero in Vulture, Basilicata, Italy, 85029
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
  • Campania
    • Avellino, Campania, Italy, 83100
    • Napoli, Campania, Italy, 80131
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
    • Carpi, Emilia-Romagna, Italy, 41012
    • Modena, Emilia-Romagna, Italy, 41100
    • Rimini, Emilia-Romagna, Italy, 47900
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
    • Udine, Friuli-Venezia Giulia, Italy, 33100
  • Lazio
    • Roma, Lazio, Italy, 00144
    • Roma, Lazio, Italy, 00161
    • Roma, Lazio, Italy, 00100
    • Sora, Lazio, Italy, 03039
    • Viterbo, Lazio, Italy, 01100
  • Liguria
    • Genova, Liguria, Italy, 16132
    • Genova, Liguria, Italy, 16149
    • La Spezia, Liguria, Italy, 19100
  • Lombardia
    • Bergamo, Lombardia, Italy, 24128
    • Cremona, Lombardia, Italy, 26100
    • Milano, Lombardia, Italy, 20132
    • Milano, Lombardia, Italy, 20162
    • Pavia, Lombardia, Italy, 27100
    • S Fermo Della Battaglia, Lombardia, Italy, 22100
    • Sondrio, Lombardia, Italy, 23100
  • Marche
    • Ancona, Marche, Italy
  • Piemonte
    • Novara, Piemonte, Italy, 28100
  • Puglia
    • Bari, Puglia, Italy, 70126
    • Brindisi, Puglia, Italy, 72100
    • San Giovanni Rotondo, Puglia, Italy, 71013
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
    • Sassari, Sardegna, Italy, 07100
  • Sicilia
    • Catania, Sicilia, Italy, 95100
    • Catania, Sicilia, Italy, 95122
    • Palermo, Sicilia, Italy, 90127
    • Taormina, Sicilia, Italy, 98039
  • Toscana
    • Arezzo, Toscana, Italy, 52100
    • Lido Di Camaiore, Toscana, Italy, 55043
    • Pisa, Toscana, Italy, 56100
  • Veneto
    • Camposampiero, Veneto, Italy, 35012
    • Feltre - Bl, Veneto, Italy, 32032
    • Negrar, Veneto, Italy, 37024
• Latvia
  • Riga, Latvia, LV-1002
  • Riga, Latvia, LV 1079
• Lebanon
  • Beirut, Lebanon, 99999
• Lithuania
  • Kaunas, Lithuania, 50009
  • Klaipeda, Lithuania, 5808
  • Vilnius, Lithuania, 08660
• Mexico
  • Chihuahua, Mexico, 31000
  • Leon, Mexico, 37150
  • Mexico City, Mexico, 16200
  • Mexico City, Mexico, 14080
• Netherlands
  • Arnhem, Netherlands, 6815 AD
  • Breda, Netherlands, 4818 CK
  • Den Haag, Netherlands, 2504 LN
  • Eindhoven, Netherlands, 5623 EJ
  • Groningen, Netherlands, 9728 NZ
  • Haarlem, Netherlands, 2035 RC
  • Helmond, Netherlands, 5700 AB
  • Hoofddorp, Netherlands, 2134 TM
  • Nieuwegein, Netherlands, 3430 CM
  • Schiedam, Netherlands, 3116 BA
  • Tiel, Netherlands, 4002 WP
  • Zwolle, Netherlands, 8011 JW
• Poland
  • Bialystok, Poland, 15-540
  • Krakow, Poland, 31-115
  • Lublin, Poland, 20-950
  • Poznan, Poland, 60-569
  • Warszawa, Poland, 02-781
  • Warszawa, Poland, 04-394
  • Zabrze, Poland, 41-483
• Portugal
  • Braga, Portugal, 4719
  • Coimbra, Portugal, 55643
  • Lisboa, Portugal, 1070
  • Lisboa, Portugal, 1600
  • Lisboa, Portugal, 17769-001
  • Porto, Portugal, 4200-072
  • Porto, Portugal, 4200
  • Santa Maria Da Feira, Portugal, 4520-211
  • Setubal, Portugal, 2910-446
  • Vila Nova De Gaia, Portugal, 4400-129
• Romania
  • Bucharest, Romania, 010816
  • Cluj Napoca, Romania, 3400
  • Timisoara, Romania, 300223
• Russian Federation
  • Balashikha, Russian Federation, 143900
  • Engels, Russian Federation, 413115
  • Irkutsk, Russian Federation, 664035
  • Kislino, Kursk Region, Russian Federation, 305035
  • Krasnodar, Russian Federation, 350086
  • Moscow, Russian Federation, 107005
  • Moscow, Russian Federation, 115478
  • Moscow, Russian Federation, 143423
  • Samara, Russian Federation, 443066
  • Smolensk, Russian Federation, 214000
  • Stavropol, Russian Federation, 355047
  • Tumen, Russian Federation, 625047
  • Tver, Russian Federation, 170008
  • Ulyanovsk, Russian Federation, ND
• Serbia
  • Belgrade, Serbia, 11000
• Slovakia
  • Bratislava, Slovakia, 825 56
  • Kosice, Slovakia, 041 90
  • Nitra, Slovakia, 949 88
  • Poprad, Slovakia, 058 87
• Slovenia
  • Golnik, Slovenia, 4204
  • Ljubljana, Slovenia, 1000
• Spain
  • Alicante, Spain, 3010
  • Barcelona, Spain, 08907
  • Barcelona, Spain, 08025
  • Barcelona, Spain, 08916
  • Girona, Spain, 17007
  • Huesca, Spain, 22004
  • La Coruña, Spain, 15006
  • Lugo, Spain, 27004
  • Madrid, Spain, 28040
  • Madrid, Spain, 28046
  • Madrid, Spain, 28034
  • Madrid, Spain, 28041
  • Madrid, Spain, 28035
  • Madrid, Spain, 28002
  • Murcia, Spain, 30008
  • Salamanca, Spain, 37007
  • Valencia, Spain, 46010
  • Valencia, Spain, 46009
  • Valencia, Spain, 41014
  • Valencia, Spain, 46015
  • Zaragoza, Spain, 50009
  • Alicante
    • Elche, Alicante, Spain, 03202
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
    • Mataro, Barcelona, Spain, 08304
    • Sabadell, Barcelona, Spain, 08208
    • Terrassa, Barcelona, Spain, 08221
  • Cantabria
    • Santander, Cantabria, Spain, 39008
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
  • Navarra
    • Pamplona, Navarra, Spain, 31008
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
• Sweden
  • Gothenburg, Sweden, 41345
  • Lund, Sweden, 22185
  • Malmoe, Sweden, 20502
  • Oerebro, Sweden, 70185
  • Stokholm, Solna, Sweden, 01716
  • Umea, Sweden, 90185
  • Uppsala, Sweden, 751 85
• Switzerland
  • Aarau, Switzerland, 5000
  • Baden, Switzerland, 5404
  • Genolier, Switzerland, 1272
  • Locarno, Switzerland, 6601
• Taiwan
  • Taichung, Taiwan, 407
  • Tainan, Taiwan, 704
  • Taipei, Taiwan, 100
  • Taipei, Taiwan, 112
  • Taoyuan, Taiwan, 333
• Turkey
  • Ankara, Turkey, 06530
  • Gaziantep, Turkey, 27310
  • Istanbul, Turkey, 34300
  • Istanbul, Turkey, 34383
  • Izmir, Turkey, 35100
  • Sıhhiye, ANKARA, Turkey, 06100
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
  • Belfast, United Kingdom, BT9 7AB
  • Birmingham, United Kingdom, B9 5SS
  • Cambridge, United Kingdom, PE3 6DA
  • Cardiff, United Kingdom, CF14 2TL
  • Manchester, United Kingdom, M23 9LT
  • Nottingham, United Kingdom, NG5 1PB
  • Suffolk, United Kingdom, IP33 2QZ
• Venezuela
  • Barcelona, Venezuela, 6001
  • Barquisimeto, Venezuela, 3001
  • Porlamar, Venezuela, 6301

Participation Criteria

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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Platinum-based chemotherapy; As prescribed; Drug: Bevacizumab [Avastin]; 15 mg/kg IV on Day 1 of each 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 years
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.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 years
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.	Up to 3 years
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.	Up to 3 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 22, 2007
• First Submitted That Met QC Criteria: March 22, 2007
• First Posted (Estimate): March 26, 2007

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: MO19390