AzTrials
AzTrials

Squamous Non-Small Cell Lung CancerPhase 3NCT02106546

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

A Phase 3 study testing Carboplatin, Veliparib and Paclitaxel in people with Squamous Non-Small Cell Lung Cancer, run by AbbVie at 225 sites in 38 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

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). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Squamous Non-Small Cell Lung Cancer
What is being tested?
Carboplatin, Veliparib and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
970 participants
Where
225 sitesin 38 countries
Study dates
10 Apr 2014to 20 Nov 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

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

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy > 12 weeks
  • Subject must have cytologically or histologically confirmed squamous NSCLC.
  • 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.
  • Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
  • 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).

Who cannot join

  • Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
  • Subject has a known hypersensitivity to platinum compounds.
  • Subject has peripheral neuropathy >= grade 2.
  • 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.
  • Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Trial locations and contacts

225 sites in 38 countries.

225 sites in 38 countries

United States38 sites

  • Illinois Cancer Specialists /ID# 127468

    Arlington Heights, Illinois, 60005

  • Winship Cancer Institute of Emory University /ID# 124061

    Atlanta, Georgia, 30322-1013

  • VA Eastern Colorado Healthcare System /ID# 128065

    Aurora, Colorado, 80045

  • Texas Oncology - Austin Midtown /ID# 127477

    Austin, Texas, 78705

  • Texas Oncology - South Austin /ID# 127476

    Austin, Texas, 78745

  • St. Luke's Mountain States Tumor Institute - Boise /ID# 124059

    Boise, Idaho, 83712

  • University of Vermont Medical Center /ID# 128064

    Burlington, Vermont, 05401-1473

  • Gabrail Cancer Center Research /ID# 127415

    Canton, Ohio, 44718

  • Parkland Health and Hosp Syste /ID# 128518

    Dallas, Texas, 75235

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385

    Dallas, Texas, 75246-2003

  • UT Southwestern Medical Center /ID# 127876

    Dallas, Texas, 75390-7208

  • Henry Ford Health System /ID# 126500

    Detroit, Michigan, 48202

  • NorthShore University HealthSystem - Evanston Hospital /ID# 128585

    Evanston, Illinois, 60201

  • Holy Cross Hospital /ID# 128074

    Fort Lauderdale, Florida, 33308

  • University of Florida - Archer /ID# 126476

    Gainesville, Florida, 32610

  • The Jones Clinic, PC /ID# 124062

    Germantown, Tennessee, 38138

  • Goshen Center for Cancer Care /ID# 123875

    Goshen, Indiana, 46526

  • Hackensack Univ Med Ctr /ID# 124057

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hosp /ID# 128360

    Harvey, Illinois, 60426

  • Appalachian Regional Healthcare, Inc (ARH) /ID# 128061

    Hazard, Kentucky, 41701

  • Penn State University and Milton S. Hershey Medical Center /ID# 126676

    Hershey, Pennsylvania, 17033

  • University of Texas MD Anderson Cancer Center /ID# 127946

    Houston, Texas, 77030

  • Franciscan St. Francis Health /ID# 126678

    Indianapolis, Indiana, 46237

  • Cancer Specialists of North Florida - Southpoint /ID# 127815

    Jacksonville, Florida, 32256

  • Northeast Arkansas Clinical Ch /ID# 128071

    Jonesboro, Arkansas, 72401

  • Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156

    Lansing, Michigan, 48912

  • Comprehensive Cancer Ctrs Neva /ID# 127491

    Las Vegas, Nevada, 89169

  • Dartmouth-Hitchcock Medical Center /ID# 128075

    Lebanon, New Hampshire, 03756

  • Nebraska Hematology Oncology /ID# 127699

    Lincoln, Nebraska, 68506

  • SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477

    Lincoln, Nebraska, 68510

  • LA Hem-Oncology Med Group /ID# 129178

    Los Angeles, California, 90017

  • Minnesota Oncology Hematology, PA /ID# 127473

    Minneapolis, Minnesota, 55404

  • Virginia Oncology Associates /ID# 127458

    Norfolk, Virginia, 23502

  • Texas Oncology - Paris /ID# 127484

    Paris, Texas, 75460

  • Northwest Cancer Specialists, P.C. /ID# 127486

    Vancouver, Washington, 98684

  • Northwest Cancer Specialists, P.C. /ID# 127488

    Vancouver, Washington, 98684

  • Texas Oncology - Waco /ID# 127459

    Waco, Texas, 76712

  • Midwestern Regional CTC /ID# 126124

    Zion, Illinois, 60099

Other trials in United States

United Kingdom13 sites

  • Betsi Cadwaladr Univ Health Bo /ID# 127177

    Bangor, LL57 2PW

  • North Devon District Hospital /ID# 125689

    Barnstaple, ES31 4JB

  • The Royal Bournemouth Hospital /ID# 125690

    Bournemouth, BH7 7DW

  • East Kent Hosp Univ NHS Trust /ID# 125698

    Canterbury, CT1 3NG

  • Cheltenham General Hospital /ID# 125692

    Cheltenham, Gloucestershire, GL53 7AN

  • Gartnavel General Hospital /ID# 126233

    Glasgow, G12 0YN

  • James Paget University Hosp /ID# 125696

    Great Yarmouth, NR31 6LA

  • Guy's and St Thomas' NHS Found /ID# 125694

    London, London, City of, SE1 9RT

  • Charing Cross Hospital /ID# 125688

    London, W6 8RF

  • Maidstone Hospital /ID# 125693

    Maidstone, ME16 9QQ

  • The Clatterbridge Cancer Ctr /ID# 125695

    Metropolitan Borough of Wirral, CH63 4JY

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228

    Newcastle upon Tyne, NE7 7DN

  • Norfolk and Norwich Univ Hosp /ID# 125697

    Norwich, Norfolk, NR4 7UY

Other trials in United Kingdom

Hungary10 sites

  • Orszagos Koranyi Pulmonologiai Intezet /ID# 126112

    Budapest XII, Budapest, 1122

  • Debreceni Egyetem Klinikai Központ /ID# 126119

    Debrecen, 4032

  • Veszprem Megyei Tudogyogyintez /ID# 126121

    Farkasgyepű, 8582

  • Petz Aladar Megyei Oktato Korh /ID# 126110

    Győr, 9023

  • Bekes Megyei Pandy Kalman Korhaz /ID# 126117

    Gyula, 5700

  • Matrahaza Gyogyintezet /ID# 126109

    Kékesteto, 3233

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Fejer Megyei Szent Gyorgy Korh /ID# 126118

    Székesfehérvár, 8000

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120

    Szolnok, 5004

  • Tudogyogyintezet Toeroekbalint /ID# 126111

    Törökbálint, 2045

Other trials in Hungary

Russia10 sites

  • Belgorod Oncology Dispensary /ID# 129899

    Belgorod, 308010

  • State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460

    Irkutsk, 664035

  • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458

    Moscow, Moscow, 115478

  • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461

    Murmansk, 183047

  • Orenburg Regional Clinical Onc /ID# 137474

    Orenburg, 460021

  • Ogarev Mordovia State Univ /ID# 127595

    Saransk, 430005

  • Smolensk Regional Onc Clin Dis /ID# 127144

    Smolensk, 214009

  • Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143

    Tomsk, 634050

  • Volgograd Regional Clinical Oncology Dispensary /ID# 126350

    Volgograd, Volgograd Oblast, 400138

  • Sverdlovsk Regional Oncology Center Dispensary /ID# 128457

    Yekaterinburg, Sverdlovsk Oblast, 620043

Other trials in Russia

Canada9 sites

  • University of Calgary /Id# 126326

    Calgary, Alberta, T2N 4Z6

  • Cross Cancer Institute /ID# 126154

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Clinic /ID# 126153

    Hamilton, Ontario, L8V 1C3

  • Victoria Hospital /ID# 126669

    London, Ontario, N6A 4L6

  • McGill Univ HC /ID# 130431

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital /ID# 126522

    Ottawa, Ontario, K1H 8L6

  • Iucpq-Ul /Id# 126524

    Québec, Quebec, G1V 4G5

  • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149

    Québec, Quebec, G6V 3Z1

  • Princess Margaret Cancer Centre /ID# 126155

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France9 sites

  • CHRU de Brest - Hopital Morvan /ID# 127903

    Brest, 29200

  • Centre Hosp Intercommunal de Creteil /ID# 125922

    Créteil, Val-de-Marne, 94000

  • Centre Hospitalier Le Mans /ID# 127902

    Le Mans, Sarthe, 72037

  • CHRU Lille - Hôpital Claude Huriez /ID# 126353

    Lille, Hauts-de-France, 59045

  • CHU Hopital Nord /ID# 128388

    Marseille, Bouches-du-Rhone, 13915

  • Centre Antoine Lacassagne /ID# 126360

    Nice, 06189

  • Hopital Haut-Lévêque /ID# 135270

    Pessac, Gironde, 33604

  • Hospital Pontchaillou /ID# 126356

    Rennes, 35033

  • Hopital Larrey - CHU de Toulouse /ID# 128394

    Toulouse, 31059

Other trials in France

South Africa9 sites

  • Netcare Oncology Intervent Ctr /ID# 126100

    Cape Town, Western Cape, 7460

  • The Oncology Centre /ID# 126096

    Durban, KwaZulu-Natal, 4091

  • Cancercare Outeniqua Oncology Unit /ID# 126103

    George, Western Cape, 6530

  • Wits Clinical Research Site /ID# 126101

    Johannesburg, Gauteng, 2193

  • Sandton Oncology Centre /ID# 126097

    Johannesburg, Gauteng, 2199

  • GVI Oncology /ID# 126102

    Port Elizabeth, Eastern Cape, 6006

  • University of Pretoria /ID# 127297

    Pretoria, Gauteng, 0001

  • Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098

    Pretoria, Gauteng, 0044

  • Mary Potter Oncology Centre /ID# 126099

    Pretoria, Gauteng, 0181

Other trials in South Africa

Italy7 sites

  • AO San Giuseppe Moscati /ID# 125701

    Avellino, 83100

  • Istituto Europeo di Oncologia /ID# 125702

    Milan, 20141

  • Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704

    Monza, 20052

  • A.O.U. San Luigi Gonzaga /ID# 125700

    Orbassano, 10043

  • Azienda Ospedaliero Uni Parma /ID# 125703

    Parma, 43100

  • Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699

    Perugia, 06100

  • Istituto Oncologico del Medite /ID# 132844

    Viagrande, 95029

Other trials in Italy

Netherlands7 sites

  • Jeroen Bosch Ziekenhuis /ID# 125709

    's-Hertogenbosch, 5223 GZ

  • Vrije Universiteit Medisch Centrum /ID# 125578

    Amsterdam, 1081 HV

  • Amphia Ziekenhuis /ID# 126466

    Breda, 4818 CK

  • Catharina Ziekenhuis /ID# 125577

    Eindhoven, 5623 EJ

  • Ziekenhuis St. Jansdal /ID# 125576

    Harderwijk, 3844 DG

  • Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710

    Heerlen, 6419 PC

  • Isala /ID# 125579

    Zwolle, 8025 AB

Other trials in Netherlands

Ukraine7 sites

  • Cherkassy Regional Onc Ctr /ID# 128222

    Cherkasy, 18000

  • Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220

    Chernivtsi, 58013

  • Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217

    Dnipro, 49102

  • Communal non-profit enterprise Regional Center of Oncology /ID# 128221

    Kharkiv, Kharkiv Oblast, 61070

  • Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218

    Lviv, 79031

  • Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223

    Poltava, 36011

  • Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219

    Sumy, 40022

Other trials in Ukraine

Australia6 sites

  • Flinders Centre for Innovation /ID# 125605

    Bedford Park, South Australia, 5042

  • Sunshine Coast University Hosp /ID# 125608

    Birtinya, Queensland, 4575

  • The Townsville Hospital /ID# 125609

    Douglas, Queensland, 4814

  • Barwon Health University Hospital Geelong /ID# 125606

    Geelong, Victoria, 3220

  • Southern Medical Day Care Ctr /ID# 125604

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital /ID# 125607

    Woodville, South Australia, 5011

Other trials in Australia

Brazil6 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736

    Barretos, São Paulo, 14784-400

  • Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738

    Itajaí, Santa Catarina, 88301-220

  • Hospital Sao Lucas da PUCRS /ID# 127737

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309

    Rio de Janeiro, 20231-050

  • Instituto COI de Educacao e Pesquisa /ID# 127739

    Rio de Janeiro, 22793-080

  • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737

    São Paulo, 01509-000

Other trials in Brazil

Norway6 sites

  • Haukeland University Hospital /ID# 126338

    Bergen, Hordaland, 5021

  • Nordland Hospital /ID# 126337

    Bodø, 8005

  • Sorlandet Sykehus HF /ID# 126341

    Kristiansand, 4615

  • Oslo Universitetssykehus, Radiumhospitalet /ID# 126335

    Oslo, 0310

  • Stavanger University Hospital /ID# 126336

    Stavanger, 4068

  • Sykehuset i Vestfold HF /ID# 126340

    Tønsberg, 3116

Other trials in Norway

Portugal6 sites

  • CCA Braga - Hospital de Braga /ID# 125837

    Braga, 4710-243

  • Ctr Hosp Univ Coimbra, EPE /ID# 125838

    Coimbra, 3000-075

  • Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761

    Guimarães, Braga District, 4835-044

  • Hospital Pulido Valente /ID# 125835

    Lisbon, 1769-001

  • IPO Porto FG, EPE /ID# 125836

    Porto, 4200-072

  • Centro Hospitalar de Sao Joao, EPE /ID# 125875

    Porto, 4200-319

Other trials in Portugal

Spain6 sites

  • Hospital Universitario Vall d'Hebron /ID# 125159

    Barcelona, 08035

  • Hospital Duran i Reynals /ID# 125161

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario HM Sanchinarro /ID# 125162

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen del Rocio /ID# 125207

    Seville, 41013

  • Fundacion Instituto Valenciano Oncologia IVO /ID# 125205

    Valencia, 46009

Other trials in Spain

Belarus5 sites

  • Bobruysk Interdistrict Onco. /ID# 128999

    Babruysk, 213825

  • Brest Regional Hospital /ID# 125955

    Brest, 224027

  • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815

    Lesnoy, 223040

  • Mogilev Reg Clin Oncology Dis /ID# 128639

    Mogilev, 212018

  • Vitebsk Reg Clin Onc Disp /ID# 125516

    Vitebsk, 210603

Other trials in Belarus

Czechia5 sites

  • Nemocnice Kyjov, prispevkova organizace /ID# 125819

    Kyjov, 697 01

  • Nemocnice Na Plesi s.r.o. /ID# 125817

    Nová Ves pod Pleší, Pribram, 262 04

  • Nemocnice Novy Jicin /ID# 125818

    Nový Jičín, 741 01

  • Fakultni Nemocnice Olomouc /ID# 125820

    Olomouc, Olomouc Region, 779 00

  • Vitkovicka nemocnice a. s. /ID# 127023

    Ostrava, 703 84

Other trials in Czechia

Germany5 sites

  • Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708

    Berlin, 12203

  • Lungen Clinic Grosshansdorf /ID# 126107

    Großhansdorf, 22927

  • Klinikum Kassel /ID# 127025

    Kassel, 34125

  • Klinik Loewenstein GmbH /ID# 126191

    Löwenstein, 74245

  • Univ Johannes Gutenberg /ID# 125603

    Mainz, 55131

Other trials in Germany

Ireland5 sites

  • Cork University Hospital /ID# 126176

    Cork, T12 E8YV

  • St. James's Hospital /ID# 126177

    Dublin, Dublin, D08 E9P6

  • Beaumont Hospital /ID# 126218

    Dublin, D09 XR63

  • University Hospital Limerick /ID# 126175

    Limerick, V94F858

  • University Hospital Waterford /ID# 126178

    Waterford, X91 ER8E

Other trials in Ireland

Serbia5 sites

  • Clinical Center Serbia /ID# 128738

    Belgrade, Beograd, 11000

  • Institute for Oncology and Rad /ID# 128721

    Belgrade, 11000

  • University Hospital Bezanijska /ID# 128761

    Belgrade, 11080

  • Institute For Pulmonary Diseas /ID# 128737

    Kamenitz, 21204

  • Clinical Center of Nis /ID# 128735

    Niš, Nisavski Okrug, 18000

Other trials in Serbia

Turkey (Türkiye)5 sites

  • Akdeniz University Medical Fac /ID# 126997

    Antalya, 07059

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186

    Istanbul, 34098

  • Marmara University Medical Fac /ID# 126187

    Istanbul, 34899

  • Ege University Medical Faculty /ID# 126189

    Izmir, 35040

  • Dr. Suat Seren Gogus Has /ID# 126190

    Izmir, 35110

Other trials in Turkey (Türkiye)

Croatia4 sites

  • Klinicki bolnicki centar Osijek /ID# 132214

    Osijek, County of Osijek-Baranja, 31000

  • Opca bolnica Pula /ID# 126540

    Pula, 52100

  • Opca bolnica Dr. Josip Bencevi /ID# 126539

    Slavonski Brod, 35000

  • Klinika za plucne bolesti Jordanovac /ID# 126537

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Egypt4 sites

  • University of Alexandria /ID# 128337

    Alexandria, 21131

  • Naser Institute for Res & Dev /ID# 129263

    Cairo, 11511

  • Cairo Uni Hosp Al Kasr El Ainy /ID# 128338

    Cairo, 11956

  • Cairo Uni Hosp Al Kasr El Ainy /ID# 128340

    Cairo, 11956

Other trials in Egypt

Greece4 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879

    Athens, 11527

  • Metropolitan Hospital /ID# 125878

    Athens, 18547

  • University General Hospital of Heraklion PA.G.N.I /ID# 125877

    Heraklion, 71110

  • Papageorgiou General Hospital Thessaloniki /ID# 125876

    Nea Efkarpia, Thessaloniki, 54603

Other trials in Greece

Israel4 sites

  • Assaf Harofeh Medical Center /ID# 127076

    Be’er Ya‘aqov, 70300

  • Hadassah University Hospital /ID# 127077

    Jerusalem, 91120

  • Meir Medical Center /ID# 127078

    Kfar Saba, 4428164

  • Sheba Medical Center /ID# 127079

    Ramat Gan, 5239424

Other trials in Israel

Poland4 sites

  • Szpital Morski im. PCK /ID# 126547

    Gdynia, 81-519

  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548

    Rzeszów, Podkarpackie Voivodeship, 35-021

  • NZOZ Magodent Ctr. Med. Ostro /ID# 126545

    Warsaw, 04-125

  • Mazowiecki Szpital Onkologiczn /ID# 126546

    Wieliszew, 05-135

Other trials in Poland

Sweden4 sites

  • Gavle Sjukhus /ID# 126444

    Gävle, 803 24

  • Sahlgrenska University Hosp /ID# 129997

    Gothenburg, 413 45

  • University Hospital Linkoping /ID# 126443

    Linköping, 581 85

  • Karolinska Univ Sjukhuset /ID# 126445

    Solna, 17176

Other trials in Sweden

Switzerland4 sites

  • Hirslanden Medical Center /ID# 128216

    Aarau, 5000

  • Inselspital, Universitaetsklinik /ID# 126347

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 126349

    Sankt Gallen, Canton of St. Gallen, 9007

  • Spital STS AG /ID# 126348

    Thun, 3600

Other trials in Switzerland

Mexico3 sites

  • Centro Estatal de Cancerologia /ID# 127583

    Chihuahua City, 31000

  • Cancerologia de Queretaro S.C. /ID# 125920

    Querétaro City, 76178

  • Hospital Angeles Centro Medico /ID# 127620

    San Luis Potosí City, 78216

Other trials in Mexico

Denmark2 sites

  • Herlev Hospital /ID# 125995

    Herlev, Capital Region, 2730

  • Odense Universitets Hospital /ID# 125996

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Estonia2 sites

  • North Estonian Medical Centre /ID# 128215

    Tallinn, 13419

  • Tartu University Hospital /ID# 127735

    Tartu, 51014

Other trials in Estonia

Finland2 sites

  • Helsinki Univ Central Hospital /ID# 125897

    Helsinki, 00290

  • Vaasa Central Hospital /ID# 125896

    Vaasa, 65130

Other trials in Finland

Latvia2 sites

  • Riga East Clinical Univ Hosp /ID# 125597

    Riga, 1038

  • P. Stradins Clinical Univ Hosp /ID# 126322

    Riga, LV-1002

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176

    Kaunas, Kaunas County, 50009

  • National Cancer Institute /ID# 126323

    Vilnius, 08660

Other trials in Lithuania

Slovakia2 sites

  • Univerzitna Nemocnica Bratislava /ID# 126342

    Bratislava, 821 01

  • MEDEON, s.r.o. /ID# 128517

    Pieštany, 921 01

Other trials in Slovakia

Austria1 site

  • Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183

    Linz, 4020

Other trials in Austria

New Zealand1 site

  • Wellington Hospital (Capital and Coast District Health Board) /ID# 125755

    Wellington, 6021

Other trials in New Zealand

Puerto Rico1 site

  • VA Caribbean Healthcare System /ID# 124562

    San Juan, 00921-3201

Other trials in Puerto Rico

About this study

Official title: 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).

Being tested
Carboplatin, Veliparib, Paclitaxel, Placebo to veliparib
Keywords
veliparib, carboplatin, paclitaxel, Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP), Overall Survival, Advanced, Metastatic, ABT-888, Squamous, Randomized, non-small cell lung cancer, placebo controlled
Medical subject headings
Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CarboplatinDrug

    Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

  • VeliparibDrug

    Also called ABT-888

    Capsules taken orally twice a day, 12 hours apart.

  • PaclitaxelDrug

    Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².

  • Placebo to veliparibDrug

    Capsules taken orally twice a day, 12 hours apart.

Study groups in NCT02106546
Study groupRoleWhat they receive
Veliparib + Carboplatin + PaclitaxelExperimentalParticipants 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.
Receives: Drug: Carboplatin; Drug: Veliparib; Drug: Paclitaxel
Placebo + Carboplatin + PaclitaxelPlacebo comparatorParticipants 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.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo to veliparib

What is being measured

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

  1. 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.

    Measured: Up to 3 years from first dose of study drug

Secondary outcomes (3)

  1. 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.

    Measured: Up to 3 years from first dose of study drug

  2. 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.

    Measured: Up to 3 years from first dose of study drug

  3. 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)

    Measured: Up to 3 years from first dose of study drug

Timeline

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

  1. First posted8 Apr 2014 (estimated)
  2. Study start10 Apr 2014
  3. Primary completion3 Jan 2017
  4. Study completion20 Nov 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
970 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02106546
Sponsor's protocol ID
M11-089
Other IDs
2013-005020-42
Status last verified
Oct 2020
First submitted
4 Apr 2014
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
Individual data sharing
Yes: 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.
Expanded access
Available

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.

    PubMed 34436928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Veliparib and Paclitaxel in people with Squamous Non-Small Cell Lung Cancer, run by AbbVie at 225 sites in 38 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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 225 sites in United States, United Kingdom, Hungary, Russia, Canada and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

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

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

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

What does the primary outcome measure?

Overall Survival (OS) in current smokers (time frame: Up to 3 years from first dose of study drug). 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 NCT02106546, which also lists 1 linked publication.

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 17 Nov 2020.

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