Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Study Overview

• Status: Completed
• Conditions: Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Veliparib; Drug: Paclitaxel; Drug: Placebo to veliparib

• Study Type: Interventional
• Enrollment (Actual): 970
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Ctr /ID# 125604
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hosp /ID# 125608
    • Douglas, Queensland, Australia, 4814
      • The Townsville Hospital /ID# 125609
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Centre for Innovation /ID# 125605
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 125607
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Barwon Health University Hospital Geelong /ID# 125606
• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183
• Belarus
  • Bobruisk, Belarus, 213825
    • Bobruysk Interdistrict Onco. /ID# 128999
  • Brest, Belarus, 224027
    • Brest Regional Hospital /ID# 125955
  • Lesnoy, Belarus, 223040
    • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815
  • Mogilev, Belarus, 212018
    • Mogilev Reg Clin Oncology Dis /ID# 128639
  • Vitebsk, Belarus, 210603
    • Vitebsk Reg Clin Onc Disp /ID# 125516
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto COI de Educacao e Pesquisa /ID# 127739
  • Sao Paulo, Brazil, 01509-000
    • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS /ID# 127737
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /Id# 126326
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute /ID# 126154
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Cancer Clinic /ID# 126153
    • London, Ontario, Canada, N6A 4L6
      • Victoria Hospital /ID# 126669
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital /ID# 126522
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre /ID# 126155
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill Univ HC /ID# 130431
    • Quebec City, Quebec, Canada, G6V 3Z1
      • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149
    • Québec, Quebec, Canada, G1V 4G5
      • Iucpq-Ul /Id# 126524
• Croatia
  • Pula, Croatia, 52100
    • Opca bolnica Pula /ID# 126540
  • Slavonski Brod, Croatia, 35000
    • Opca bolnica Dr. Josip Bencevi /ID# 126539
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinika za plucne bolesti Jordanovac /ID# 126537
  • Osjecko-baranjska Zupanija
    • Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
      • Klinicki bolnicki centar Osijek /ID# 132214
• Czechia
  • Kyjov, Czechia, 697 01
    • Nemocnice Kyjov, prispevkova organizace /ID# 125819
  • Nový Jičín 1, Czechia, 741 01
    • Nemocnice Novy Jicin /ID# 125818
  • Ostrava, Czechia, 703 84
    • Vitkovicka nemocnice a. s. /ID# 127023
  • Olomoucky Kraj
    • Olomouc, Olomoucky Kraj, Czechia, 779 00
      • Fakultni Nemocnice Olomouc /ID# 125820
  • Pribram
    • Nová Ves pod Pleší, Pribram, Czechia, 262 04
      • Nemocnice Na Plesi s.r.o. /ID# 125817
• Denmark
  • Hovedstaden
    • Herlev, Hovedstaden, Denmark, 2730
      • Herlev Hospital /ID# 125995
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense Universitets Hospital /ID# 125996
• Egypt
  • Alexandria, Egypt, 21131
    • University of Alexandria /ID# 128337
  • Cairo, Egypt, 11511
    • Naser Institute for Res & Dev /ID# 129263
  • Cairo, Egypt, 11956
    • Cairo Uni Hosp Al Kasr El Ainy /ID# 128338
  • Cairo, Egypt, 11956
    • Cairo Uni Hosp Al Kasr El Ainy /ID# 128340
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonian Medical Centre /ID# 128215
  • Tartu, Estonia, 51014
    • Tartu University Hospital /ID# 127735
• Finland
  • Helsinki, Finland, 00290
    • Helsinki Univ Central Hospital /ID# 125897
  • Vaasa, Finland, 65130
    • Vaasa Central Hospital /ID# 125896
• France
  • Brest, France, 29200
    • CHRU de Brest - Hopital Morvan /ID# 127903
  • Nice, France, 06189
    • Centre Antoine Lacassagne /ID# 126360
  • Rennes, France, 35033
    • Hospital Pontchaillou /ID# 126356
  • Toulouse, France, 31059
    • Hopital Larrey - CHU de Toulouse /ID# 128394
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13915
      • CHU Hopital Nord /ID# 128388
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Hopital Haut-Lévêque /ID# 135270
  • Hauts-de-France
    • Lille CEDEX, Hauts-de-France, France, 59045
      • CHRU Lille - Hôpital Claude Huriez /ID# 126353
  • Sarthe
    • Le Mans CEDEX 9, Sarthe, France, 72037
      • Centre Hospitalier Le Mans /ID# 127902
  • Val-de-Marne
    • Creteil, Val-de-Marne, France, 94000
      • Centre Hosp Intercommunal de Creteil /ID# 125922
• Germany
  • Berlin, Germany, 12203
    • Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708
  • Grosshansdorf, Germany, 22927
    • Lungen Clinic Grosshansdorf /ID# 126107
  • Kassel, Germany, 34125
    • Klinikum Kassel /ID# 127025
  • Löwenstein, Germany, 74245
    • Klinik Loewenstein GmbH /ID# 126191
  • Mainz, Germany, 55131
    • Univ Johannes Gutenberg /ID# 125603
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879
  • Athens, Greece, 18547
    • Metropolitan Hospital /ID# 125878
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion PA.G.N.I /ID# 125877
  • Thessaloniki
    • Nea Efkarpia, Thessaloniki, Greece, 54603
      • Papageorgiou General Hospital Thessaloniki /ID# 125876
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Központ /ID# 126119
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Tudogyogyintez /ID# 126121
  • Gyor, Hungary, 9023
    • Petz Aladar Megyei Oktato Korh /ID# 126110
  • Gyula, Hungary, 5700
    • Bekes Megyei Pandy Kalman Korhaz /ID# 126117
  • Kékesteto, Hungary, 3233
    • Matrahaza Gyogyintezet /ID# 126109
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Korh /ID# 126118
  • Szolnok, Hungary, 5004
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Toeroekbalint /ID# 126111
  • Borsod-Abauj-Zemplen
    • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
      • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234
  • Budapest
    • Budapest XII, Budapest, Hungary, 1122
      • Orszagos Koranyi Pulmonologiai Intezet /ID# 126112
• Ireland
  • Cork, Ireland, T12 E8YV
    • Cork University Hospital /ID# 126176
  • Dublin, Ireland, D09 XR63
    • Beaumont Hospital /ID# 126218
  • Limerick, Ireland, V94F858
    • University Hospital Limerick /ID# 126175
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford /ID# 126178
  • Dublin
    • Dublin 8, Dublin, Ireland, D08 E9P6
      • St. James's Hospital /ID# 126177
• Israel
  • Be'er Ya'akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 127076
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital /ID# 127077
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 127078
  • Ramat Gan, Israel, 5239424
    • Sheba Medical Center /ID# 127079
• Italy
  • Avellino, Italy, 83100
    • AO San Giuseppe Moscati /ID# 125701
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia /ID# 125702
  • Monza, Italy, 20052
    • Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704
  • Orbassano, Italy, 10043
    • A.O.U. San Luigi Gonzaga /ID# 125700
  • Parma, Italy, 43100
    • Azienda Ospedaliero Uni Parma /ID# 125703
  • Perugia, Italy, 06100
    • Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699
  • Viagrande, Italy, 95029
    • Istituto Oncologico del Medite /ID# 132844
• Latvia
  • Riga, Latvia, 1038
    • Riga East Clinical Univ Hosp /ID# 125597
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical Univ Hosp /ID# 126322
• Lithuania
  • Vilnius, Lithuania, 08660
    • National Cancer Institute /ID# 126323
  • Kaunas
    • Kovno, Kaunas, Lithuania, 50009
      • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176
• Mexico
  • Chihuahua, Mexico, 31000
    • Centro Estatal de Cancerologia /ID# 127583
  • San Luis Potosí, Mexico, 78216
    • Hospital Angeles Centro Medico /ID# 127620
  • Santiago de Querétaro, Mexico, 76178
    • Cancerologia de Queretaro S.C. /ID# 125920
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Vrije Universiteit Medisch Centrum /ID# 125578
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis /ID# 126466
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis /ID# 125577
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St. Jansdal /ID# 125576
  • Heerlen, Netherlands, 6419 PC
    • Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710
  • S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis /ID# 125709
  • Zwolle, Netherlands, 8025 AB
    • Isala /ID# 125579
• New Zealand
  • Wellington, New Zealand, 6021
    • Wellington Hospital (Capital and Coast District Health Board) /ID# 125755
• Norway
  • Bodø, Norway, 8005
    • Nordland Hospital /ID# 126337
  • Kristiansand, Norway, 4615
    • Sorlandet Sykehus HF /ID# 126341
  • Oslo, Norway, 0310
    • Oslo Universitetssykehus, Radiumhospitalet /ID# 126335
  • Stavanger, Norway, 4068
    • Stavanger University Hospital /ID# 126336
  • Tonsberg, Norway, 3116
    • Sykehuset i Vestfold HF /ID# 126340
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital /ID# 126338
• Poland
  • Gdynia, Poland, 81-519
    • Szpital Morski im. PCK /ID# 126547
  • Warsaw, Poland, 04-125
    • NZOZ Magodent Ctr. Med. Ostro /ID# 126545
  • Wieliszew, Poland, 05-135
    • Mazowiecki Szpital Onkologiczn /ID# 126546
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-021
      • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548
• Portugal
  • Braga, Portugal, 4710-243
    • CCA Braga - Hospital de Braga /ID# 125837
  • Coimbra, Portugal, 3000-075
    • Ctr Hosp Univ Coimbra, EPE /ID# 125838
  • Lisbon, Portugal, 1769-001
    • Hospital Pulido Valente /ID# 125835
  • Porto, Portugal, 4200-072
    • IPO Porto FG, EPE /ID# 125836
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE /ID# 125875
  • Braga
    • Guimaraes, Braga, Portugal, 4835-044
      • Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761
• Puerto Rico
  • San Juan, Puerto Rico, 00921-3201
    • VA Caribbean Healthcare System /ID# 124562
• Russian Federation
  • Belgorod, Russian Federation, 308010
    • Belgorod Oncology Dispensary /ID# 129899
  • Irkutsk, Russian Federation, 664035
    • State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460
  • Murmansk, Russian Federation, 183047
    • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461
  • Orenburg, Russian Federation, 460021
    • Orenburg Regional Clinical Onc /ID# 137474
  • Saransk, Russian Federation, 430005
    • Ogarev Mordovia State Univ /ID# 127595
  • Smolensk, Russian Federation, 214009
    • Smolensk Regional Onc Clin Dis /ID# 127144
  • Tomsk, Russian Federation, 634050
    • Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143
  • Moskva
    • Moscow, Moskva, Russian Federation, 115478
      • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458
  • Sverdlovskaya Oblast
    • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
      • Sverdlovsk Regional Oncology Center Dispensary /ID# 128457
  • Volgogradskaya Oblast
    • Volgograd, Volgogradskaya Oblast, Russian Federation, 400138
      • Volgograd Regional Clinical Oncology Dispensary /ID# 126350
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Rad /ID# 128721
  • Belgrade, Serbia, 11080
    • University Hospital Bezanijska /ID# 128761
  • Sremska Kamenica, Serbia, 21204
    • Institute For Pulmonary Diseas /ID# 128737
  • Beograd
    • Belgrade, Beograd, Serbia, 11000
      • Clinical Center Serbia /ID# 128738
  • Nisavski Okrug
    • NIS, Nisavski Okrug, Serbia, 18000
      • Clinical Center of Nis /ID# 128735
• Slovakia
  • Bratislava, Slovakia, 821 01
    • Univerzitna Nemocnica Bratislava /ID# 126342
  • Pieštany, Slovakia, 921 01
    • MEDEON, s.r.o. /ID# 128517
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6006
      • GVI Oncology /ID# 126102
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Wits Clinical Research Site /ID# 126101
    • Johannesburg, Gauteng, South Africa, 2199
      • Sandton Oncology Centre /ID# 126097
    • Pretoria, Gauteng, South Africa, 0001
      • University of Pretoria /ID# 127297
    • Pretoria, Gauteng, South Africa, 0044
      • Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre /ID# 126099
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre /ID# 126096
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7460
      • Netcare Oncology Intervent Ctr /ID# 126100
    • George, Western Cape, South Africa, 6530
      • Cancercare Outeniqua Oncology Unit /ID# 126103
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 125159
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 125162
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 125207
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano Oncologia IVO /ID# 125205
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Duran i Reynals /ID# 125161
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160
• Sweden
  • Gavle, Sweden, 803 24
    • Gavle Sjukhus /ID# 126444
  • Goteborg, Sweden, 413 45
    • Sahlgrenska University Hosp /ID# 129997
  • Linkoping, Sweden, 581 85
    • University Hospital Linkoping /ID# 126443
  • Solna, Sweden, 17176
    • Karolinska Univ Sjukhuset /ID# 126445
• Switzerland
  • Aarau, Switzerland, 5000
    • Hirslanden Medical Center /ID# 128216
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsklinik /ID# 126347
  • Thun, Switzerland, 3600
    • Spital STS AG /ID# 126348
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 126349
• Turkey
  • Antalya, Turkey, 07059
    • Akdeniz University Medical Fac /ID# 126997
  • Istanbul, Turkey, 34098
    • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186
  • Istanbul, Turkey, 34899
    • Marmara University Medical Fac /ID# 126187
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 126189
  • Izmir, Turkey, 35110
    • Dr. Suat Seren Gogus Has /ID# 126190
• Ukraine
  • Cherkasy, Ukraine, 18000
    • Cherkassy Regional Onc Ctr /ID# 128222
  • Chernivtsi, Ukraine, 58013
    • Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220
  • Dnipro, Ukraine, 49102
    • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217
  • Lviv, Ukraine, 79031
    • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223
  • Sumy, Ukraine, 40022
    • Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219
  • Kharkivska Oblast
    • Kharkiv, Kharkivska Oblast, Ukraine, 61070
      • Communal non-profit enterprise Regional Center of Oncology /ID# 128221
• United Kingdom
  • Bangor, United Kingdom, LL57 2PW
    • Betsi Cadwaladr Univ Health Bo /ID# 127177
  • Barnstaple, United Kingdom, ES31 4JB
    • North Devon District Hospital /ID# 125689
  • Bournemouth, United Kingdom, BH7 7DW
    • The Royal Bournemouth Hospital /ID# 125690
  • Canterbury, United Kingdom, CT1 3NG
    • East Kent Hosp Univ NHS Trust /ID# 125698
  • Glasgow, United Kingdom, G12 0YN
    • Gartnavel General Hospital /ID# 126233
  • Great Yarmouth, United Kingdom, NR31 6LA
    • James Paget University Hosp /ID# 125696
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital /ID# 125688
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital /ID# 125693
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228
  • Wirral, United Kingdom, CH63 4JY
    • The Clatterbridge Cancer Ctr /ID# 125695
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
      • Cheltenham General Hospital /ID# 125692
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guy's and St Thomas' NHS Found /ID# 125694
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich Univ Hosp /ID# 125697
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Northeast Arkansas Clinical Ch /ID# 128071
  • California
    • Los Angeles, California, United States, 90017
      • LA Hem-Oncology Med Group /ID# 129178
  • Colorado
    • Aurora, Colorado, United States, 80045
      • VA Eastern Colorado Healthcare System /ID# 128065
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital /ID# 128074
    • Gainesville, Florida, United States, 32610
      • University of Florida - Archer /ID# 126476
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida - Southpoint /ID# 127815
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Winship Cancer Institute of Emory University /ID# 124061
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Mountain States Tumor Institute - Boise /ID# 124059
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Cancer Specialists /ID# 127468
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem - Evanston Hospital /ID# 128585
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hosp /ID# 128360
    • Zion, Illinois, United States, 60099
      • Midwestern Regional CTC /ID# 126124
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 123875
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Health /ID# 126678
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Appalachian Regional Healthcare, Inc (ARH) /ID# 128061
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 126500
    • Lansing, Michigan, United States, 48912
      • Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, PA /ID# 127473
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology Oncology /ID# 127699
    • Lincoln, Nebraska, United States, 68510
      • SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Ctrs Neva /ID# 127491
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 128075
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Univ Med Ctr /ID# 124057
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 127415
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University and Milton S. Hershey Medical Center /ID# 126676
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Jones Clinic, PC /ID# 124062
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology - Austin Midtown /ID# 127477
    • Austin, Texas, United States, 78745
      • Texas Oncology - South Austin /ID# 127476
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hosp Syste /ID# 128518
    • Dallas, Texas, United States, 75246-2003
      • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385
    • Dallas, Texas, United States, 75390-7208
      • UT Southwestern Medical Center /ID# 127876
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center /ID# 127946
    • Paris, Texas, United States, 75460
      • Texas Oncology - Paris /ID# 127484
    • Waco, Texas, United States, 76712
      • Texas Oncology - Waco /ID# 127459
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • University of Vermont Medical Center /ID# 128064
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates /ID# 127458
  • Washington
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C. /ID# 127486
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C. /ID# 127488

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Life expectancy > 12 weeks
2. Subject must have cytologically or histologically confirmed squamous NSCLC.
3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).

Exclusion Criteria:

1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
2. Subject has a known hypersensitivity to platinum compounds.
3. Subject has peripheral neuropathy >= grade 2.
4. Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
5. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veliparib + Carboplatin + Paclitaxel; Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.	Drug: Carboplatin; Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.; Drug: Veliparib; Capsules taken orally twice a day, 12 hours apart.; Other Names: ABT-888; Drug: Paclitaxel; Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Placebo Comparator: Placebo + Carboplatin + Paclitaxel; Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.	Drug: Carboplatin; Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.; Drug: Paclitaxel; Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².; Drug: Placebo to veliparib; Capsules taken orally twice a day, 12 hours apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in current smokers	Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.	Up to 3 years from first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in all subjects	Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.	Up to 3 years from first dose of study drug
Progressive-Free Survival (PFS) in current smokers and in all subjects	Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.	Up to 3 years from first dose of study drug
Objective Response Rate (ORR) in current smokers and in all subjects	Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)	Up to 3 years from first dose of study drug

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).		From Screening (prior to dosing) up to 2 years
Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13).		From Screening (prior to dosing) up to 2 years
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status		From Screening (prior to dosing) up to 2 years
Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)		From Screening (prior to dosing) up to 2 years
Duration of Response	The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.	From complete or partial response to disease progression (up to 3 years from randomization).

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Ramalingam SS, Novello S, Guclu SZ, Bentsion D, Zvirbule Z, Szilasi M, Bernabe R, Syrigos K, Byers LA, Clingan P, Bar J, Vokes EE, Govindan R, Dunbar M, Ansell P, He L, Huang X, Sehgal V, Glasgow J, Bach BA, Mazieres J. Veliparib in Combination With Platinum-Based Chemotherapy for First-Line Treatment of Advanced Squamous Cell Lung Cancer: A Randomized, Multicenter Phase III Study. J Clin Oncol. 2021 Nov 10;39(32):3633-3644. doi: 10.1200/JCO.20.03318. Epub 2021 Aug 26.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2014
• Primary Completion (Actual): January 3, 2017
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: veliparib; ABT-888; non-small cell lung cancer; paclitaxel; carboplatin; Randomized; Advanced; Metastatic; Squamous; placebo controlled; Overall Survival; Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)
• 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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Poly(ADP-ribose) Polymerase Inhibitors; Carboplatin; Paclitaxel; Veliparib
• Other Study ID Numbers: M11-089; 2013-005020-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• product manufactured in and exported from the U.S.: No