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)
2 other identifiers
interventional
970
35 countries
213
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
Longer than P75 for phase_3
213 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedStudy Start
First participant enrolled
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedNovember 17, 2020
October 1, 2020
2.7 years
April 4, 2014
November 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to 3 years from first dose of study drug
Secondary Outcomes (3)
Overall Survival (OS) in all subjects
Up to 3 years from first dose of study drug
Progressive-Free Survival (PFS) in current smokers and in all subjects
Up to 3 years from first dose of study drug
Objective Response Rate (ORR) in current smokers and in all subjects
Up to 3 years from first dose of study drug
Other Outcomes (5)
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
- +2 more other outcomes
Study Arms (2)
Veliparib + Carboplatin + Paclitaxel
EXPERIMENTALParticipants 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.
Placebo + Carboplatin + Paclitaxel
PLACEBO 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.
Interventions
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
Capsules taken orally twice a day, 12 hours apart.
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Capsules taken orally twice a day, 12 hours apart.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (225)
Northeast Arkansas Clinical Ch /ID# 128071
Jonesboro, Arkansas, 72401, United States
LA Hem-Oncology Med Group /ID# 129178
Los Angeles, California, 90017, United States
VA Eastern Colorado Healthcare System /ID# 128065
Aurora, Colorado, 80045, United States
Holy Cross Hospital /ID# 128074
Fort Lauderdale, Florida, 33308, United States
University of Florida - Archer /ID# 126476
Gainesville, Florida, 32610, United States
Cancer Specialists of North Florida - Southpoint /ID# 127815
Jacksonville, Florida, 32256, United States
Winship Cancer Institute of Emory University /ID# 124061
Atlanta, Georgia, 30322-1013, United States
St. Luke's Mountain States Tumor Institute - Boise /ID# 124059
Boise, Idaho, 83712, United States
Illinois Cancer Specialists /ID# 127468
Arlington Heights, Illinois, 60005, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 128585
Evanston, Illinois, 60201, United States
Ingalls Memorial Hosp /ID# 128360
Harvey, Illinois, 60426, United States
Midwestern Regional CTC /ID# 126124
Zion, Illinois, 60099, United States
Goshen Center for Cancer Care /ID# 123875
Goshen, Indiana, 46526, United States
Franciscan St. Francis Health /ID# 126678
Indianapolis, Indiana, 46237, United States
Appalachian Regional Healthcare, Inc (ARH) /ID# 128061
Hazard, Kentucky, 41701, United States
Henry Ford Health System /ID# 126500
Detroit, Michigan, 48202, United States
Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156
Lansing, Michigan, 48912, United States
Minnesota Oncology Hematology, PA /ID# 127473
Minneapolis, Minnesota, 55404, United States
Nebraska Hematology Oncology /ID# 127699
Lincoln, Nebraska, 68506, United States
SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477
Lincoln, Nebraska, 68510, United States
Comprehensive Cancer Ctrs Neva /ID# 127491
Las Vegas, Nevada, 89169, United States
Dartmouth-Hitchcock Medical Center /ID# 128075
Lebanon, New Hampshire, 03756, United States
Hackensack Univ Med Ctr /ID# 124057
Hackensack, New Jersey, 07601, United States
Gabrail Cancer Center Research /ID# 127415
Canton, Ohio, 44718, United States
Penn State University and Milton S. Hershey Medical Center /ID# 126676
Hershey, Pennsylvania, 17033, United States
The Jones Clinic, PC /ID# 124062
Germantown, Tennessee, 38138, United States
Texas Oncology - Austin Midtown /ID# 127477
Austin, Texas, 78705, United States
Texas Oncology - South Austin /ID# 127476
Austin, Texas, 78745, United States
Parkland Health and Hosp Syste /ID# 128518
Dallas, Texas, 75235, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385
Dallas, Texas, 75246-2003, United States
UT Southwestern Medical Center /ID# 127876
Dallas, Texas, 75390-7208, United States
University of Texas MD Anderson Cancer Center /ID# 127946
Houston, Texas, 77030, United States
Texas Oncology - Paris /ID# 127484
Paris, Texas, 75460, United States
Texas Oncology - Waco /ID# 127459
Waco, Texas, 76712, United States
University of Vermont Medical Center /ID# 128064
Burlington, Vermont, 05401-1473, United States
Virginia Oncology Associates /ID# 127458
Norfolk, Virginia, 23502, United States
Northwest Cancer Specialists, P.C. /ID# 127486
Vancouver, Washington, 98684, United States
Northwest Cancer Specialists, P.C. /ID# 127488
Vancouver, Washington, 98684, United States
Southern Medical Day Care Ctr /ID# 125604
Wollongong, New South Wales, 2500, Australia
Sunshine Coast University Hosp /ID# 125608
Birtinya, Queensland, 4575, Australia
The Townsville Hospital /ID# 125609
Douglas, Queensland, 4814, Australia
Flinders Centre for Innovation /ID# 125605
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital /ID# 125607
Woodville, South Australia, 5011, Australia
Barwon Health University Hospital Geelong /ID# 125606
Geelong, Victoria, 3220, Australia
Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183
Linz, 4020, Austria
Bobruysk Interdistrict Onco. /ID# 128999
Babruysk, 213825, Belarus
Brest Regional Hospital /ID# 125955
Brest, 224027, Belarus
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815
Lesnoy, 223040, Belarus
Mogilev Reg Clin Oncology Dis /ID# 128639
Mogilev, 212018, Belarus
Vitebsk Reg Clin Onc Disp /ID# 125516
Vitebsk, 210603, Belarus
Hospital Sao Lucas da PUCRS /ID# 127737
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738
Itajaí, Santa Catarina, 88301-220, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736
Barretos, São Paulo, 14784-400, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309
Rio de Janeiro, 20231-050, Brazil
Instituto COI de Educacao e Pesquisa /ID# 127739
Rio de Janeiro, 22793-080, Brazil
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737
São Paulo, 01509-000, Brazil
University of Calgary /Id# 126326
Calgary, Alberta, T2N 4Z6, Canada
Cross Cancer Institute /ID# 126154
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Clinic /ID# 126153
Hamilton, Ontario, L8V 1C3, Canada
Victoria Hospital /ID# 126669
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital /ID# 126522
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre /ID# 126155
Toronto, Ontario, M5G 2M9, Canada
McGill Univ HC /ID# 130431
Montreal, Quebec, H3G 1A4, Canada
Iucpq-Ul /Id# 126524
Québec, Quebec, G1V 4G5, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149
Québec, Quebec, G6V 3Z1, Canada
Klinika za plucne bolesti Jordanovac /ID# 126537
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Osijek /ID# 132214
Osijek, County of Osijek-Baranja, 31000, Croatia
Opca bolnica Pula /ID# 126540
Pula, 52100, Croatia
Opca bolnica Dr. Josip Bencevi /ID# 126539
Slavonski Brod, 35000, Croatia
Fakultni Nemocnice Olomouc /ID# 125820
Olomouc, Olomoucký kraj, 779 00, Czechia
Nemocnice Na Plesi s.r.o. /ID# 125817
Nová Ves pod Pleší, Pribram, 262 04, Czechia
Nemocnice Kyjov, prispevkova organizace /ID# 125819
Kyjov, 697 01, Czechia
Nemocnice Novy Jicin /ID# 125818
Nový Jičín, 741 01, Czechia
Vitkovicka nemocnice a. s. /ID# 127023
Ostrava, 703 84, Czechia
Herlev Hospital /ID# 125995
Herlev, Capital Region, 2730, Denmark
Odense Universitets Hospital /ID# 125996
Odense C, Region Syddanmark, 5000, Denmark
University of Alexandria /ID# 128337
Alexandria, 21131, Egypt
Naser Institute for Res & Dev /ID# 129263
Cairo, 11511, Egypt
Cairo Uni Hosp Al Kasr El Ainy /ID# 128338
Cairo, 11956, Egypt
Cairo Uni Hosp Al Kasr El Ainy /ID# 128340
Cairo, 11956, Egypt
North Estonian Medical Centre /ID# 128215
Tallinn, 13419, Estonia
Tartu University Hospital /ID# 127735
Tartu, 51014, Estonia
Helsinki Univ Central Hospital /ID# 125897
Helsinki, 00290, Finland
Vaasa Central Hospital /ID# 125896
Vaasa, 65130, Finland
CHU Hopital Nord /ID# 128388
Marseille, Bouches-du-Rhone, 13915, France
Hopital Haut-Lévêque /ID# 135270
Pessac, Gironde, 33604, France
CHRU Lille - Hôpital Claude Huriez /ID# 126353
Lille, Hauts-de-France, 59045, France
Centre Hospitalier Le Mans /ID# 127902
Le Mans, Sarthe, 72037, France
Centre Hosp Intercommunal de Creteil /ID# 125922
Créteil, Val-de-Marne, 94000, France
CHRU de Brest - Hopital Morvan /ID# 127903
Brest, 29200, France
Centre Antoine Lacassagne /ID# 126360
Nice, 06189, France
Hospital Pontchaillou /ID# 126356
Rennes, 35033, France
Hopital Larrey - CHU de Toulouse /ID# 128394
Toulouse, 31059, France
Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708
Berlin, 12203, Germany
Lungen Clinic Grosshansdorf /ID# 126107
Großhansdorf, 22927, Germany
Klinikum Kassel /ID# 127025
Kassel, 34125, Germany
Klinik Loewenstein GmbH /ID# 126191
Löwenstein, 74245, Germany
Univ Johannes Gutenberg /ID# 125603
Mainz, 55131, Germany
Papageorgiou General Hospital Thessaloniki /ID# 125876
Nea Efkarpia, Thessaloniki, 54603, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879
Athens, 11527, Greece
Metropolitan Hospital /ID# 125878
Athens, 18547, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 125877
Heraklion, 71110, Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 126112
Budapest XII, Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Központ /ID# 126119
Debrecen, 4032, Hungary
Veszprem Megyei Tudogyogyintez /ID# 126121
Farkasgyepű, 8582, Hungary
Petz Aladar Megyei Oktato Korh /ID# 126110
Győr, 9023, Hungary
Bekes Megyei Pandy Kalman Korhaz /ID# 126117
Gyula, 5700, Hungary
Matrahaza Gyogyintezet /ID# 126109
Kékesteto, 3233, Hungary
Fejer Megyei Szent Gyorgy Korh /ID# 126118
Székesfehérvár, 8000, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120
Szolnok, 5004, Hungary
Tudogyogyintezet Toeroekbalint /ID# 126111
Törökbálint, 2045, Hungary
St. James's Hospital /ID# 126177
Dublin, Dublin, D08 E9P6, Ireland
Cork University Hospital /ID# 126176
Cork, T12 E8YV, Ireland
Beaumont Hospital /ID# 126218
Dublin, D09 XR63, Ireland
University Hospital Limerick /ID# 126175
Limerick, V94F858, Ireland
University Hospital Waterford /ID# 126178
Waterford, X91 ER8E, Ireland
Assaf Harofeh Medical Center /ID# 127076
Be’er Ya‘aqov, 70300, Israel
Hadassah University Hospital /ID# 127077
Jerusalem, 91120, Israel
Meir Medical Center /ID# 127078
Kfar Saba, 4428164, Israel
Sheba Medical Center /ID# 127079
Ramat Gan, 5239424, Israel
AO San Giuseppe Moscati /ID# 125701
Avellino, 83100, Italy
Istituto Europeo di Oncologia /ID# 125702
Milan, 20141, Italy
Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704
Monza, 20052, Italy
A.O.U. San Luigi Gonzaga /ID# 125700
Orbassano, 10043, Italy
Azienda Ospedaliero Uni Parma /ID# 125703
Parma, 43100, Italy
Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699
Perugia, 06100, Italy
Istituto Oncologico del Medite /ID# 132844
Viagrande, 95029, Italy
Riga East Clinical Univ Hosp /ID# 125597
Riga, 1038, Latvia
P. Stradins Clinical Univ Hosp /ID# 126322
Riga, LV-1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176
Kaunas, Kaunas County, 50009, Lithuania
National Cancer Institute /ID# 126323
Vilnius, 08660, Lithuania
Centro Estatal de Cancerologia /ID# 127583
Chihuahua City, 31000, Mexico
Cancerologia de Queretaro S.C. /ID# 125920
Querétaro City, 76178, Mexico
Hospital Angeles Centro Medico /ID# 127620
San Luis Potosí City, 78216, Mexico
Jeroen Bosch Ziekenhuis /ID# 125709
's-Hertogenbosch, 5223 GZ, Netherlands
Vrije Universiteit Medisch Centrum /ID# 125578
Amsterdam, 1081 HV, Netherlands
Amphia Ziekenhuis /ID# 126466
Breda, 4818 CK, Netherlands
Catharina Ziekenhuis /ID# 125577
Eindhoven, 5623 EJ, Netherlands
Ziekenhuis St. Jansdal /ID# 125576
Harderwijk, 3844 DG, Netherlands
Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710
Heerlen, 6419 PC, Netherlands
Isala /ID# 125579
Zwolle, 8025 AB, Netherlands
Wellington Hospital (Capital and Coast District Health Board) /ID# 125755
Wellington, 6021, New Zealand
Haukeland University Hospital /ID# 126338
Bergen, Hordaland, 5021, Norway
Nordland Hospital /ID# 126337
Bodø, 8005, Norway
Sorlandet Sykehus HF /ID# 126341
Kristiansand, 4615, Norway
Oslo Universitetssykehus, Radiumhospitalet /ID# 126335
Oslo, 0310, Norway
Stavanger University Hospital /ID# 126336
Stavanger, 4068, Norway
Sykehuset i Vestfold HF /ID# 126340
Tønsberg, 3116, Norway
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Szpital Morski im. PCK /ID# 126547
Gdynia, 81-519, Poland
NZOZ Magodent Ctr. Med. Ostro /ID# 126545
Warsaw, 04-125, Poland
Mazowiecki Szpital Onkologiczn /ID# 126546
Wieliszew, 05-135, Poland
Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761
Guimarães, Braga District, 4835-044, Portugal
CCA Braga - Hospital de Braga /ID# 125837
Braga, 4710-243, Portugal
Ctr Hosp Univ Coimbra, EPE /ID# 125838
Coimbra, 3000-075, Portugal
Hospital Pulido Valente /ID# 125835
Lisbon, 1769-001, Portugal
IPO Porto FG, EPE /ID# 125836
Porto, 4200-072, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 125875
Porto, 4200-319, Portugal
VA Caribbean Healthcare System /ID# 124562
San Juan, 00921-3201, Puerto Rico
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458
Moscow, Moscow, 115478, Russia
Sverdlovsk Regional Oncology Center Dispensary /ID# 128457
Yekaterinburg, Sverdlovsk Oblast, 620043, Russia
Volgograd Regional Clinical Oncology Dispensary /ID# 126350
Volgograd, Volgograd Oblast, 400138, Russia
Belgorod Oncology Dispensary /ID# 129899
Belgorod, 308010, Russia
State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460
Irkutsk, 664035, Russia
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461
Murmansk, 183047, Russia
Orenburg Regional Clinical Onc /ID# 137474
Orenburg, 460021, Russia
Ogarev Mordovia State Univ /ID# 127595
Saransk, 430005, Russia
Smolensk Regional Onc Clin Dis /ID# 127144
Smolensk, 214009, Russia
Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143
Tomsk, 634050, Russia
Clinical Center Serbia /ID# 128738
Belgrade, Beograd, 11000, Serbia
Clinical Center of Nis /ID# 128735
Niš, Nisavski Okrug, 18000, Serbia
Institute for Oncology and Rad /ID# 128721
Belgrade, 11000, Serbia
University Hospital Bezanijska /ID# 128761
Belgrade, 11080, Serbia
Institute For Pulmonary Diseas /ID# 128737
Kamenitz, 21204, Serbia
Univerzitna Nemocnica Bratislava /ID# 126342
Bratislava, 821 01, Slovakia
MEDEON, s.r.o. /ID# 128517
Pieštany, 921 01, Slovakia
GVI Oncology /ID# 126102
Port Elizabeth, Eastern Cape, 6006, South Africa
Wits Clinical Research Site /ID# 126101
Johannesburg, Gauteng, 2193, South Africa
Sandton Oncology Centre /ID# 126097
Johannesburg, Gauteng, 2199, South Africa
University of Pretoria /ID# 127297
Pretoria, Gauteng, 0001, South Africa
Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098
Pretoria, Gauteng, 0044, South Africa
Mary Potter Oncology Centre /ID# 126099
Pretoria, Gauteng, 0181, South Africa
The Oncology Centre /ID# 126096
Durban, KwaZulu-Natal, 4091, South Africa
Netcare Oncology Intervent Ctr /ID# 126100
Cape Town, Western Cape, 7460, South Africa
Cancercare Outeniqua Oncology Unit /ID# 126103
George, Western Cape, 6530, South Africa
Hospital Duran i Reynals /ID# 125161
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Vall d'Hebron /ID# 125159
Barcelona, 08035, Spain
Hospital Universitario HM Sanchinarro /ID# 125162
Madrid, 28050, Spain
Hospital Universitario Virgen del Rocio /ID# 125207
Seville, 41013, Spain
Fundacion Instituto Valenciano Oncologia IVO /ID# 125205
Valencia, 46009, Spain
Gavle Sjukhus /ID# 126444
Gävle, 803 24, Sweden
Sahlgrenska University Hosp /ID# 129997
Gothenburg, 413 45, Sweden
University Hospital Linkoping /ID# 126443
Linköping, 581 85, Sweden
Karolinska Univ Sjukhuset /ID# 126445
Solna, 17176, Sweden
Kantonsspital St. Gallen /ID# 126349
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Hirslanden Medical Center /ID# 128216
Aarau, 5000, Switzerland
Inselspital, Universitaetsklinik /ID# 126347
Bern, 3010, Switzerland
Spital STS AG /ID# 126348
Thun, 3600, Switzerland
Akdeniz University Medical Fac /ID# 126997
Antalya, 07059, Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186
Istanbul, 34098, Turkey (Türkiye)
Marmara University Medical Fac /ID# 126187
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty /ID# 126189
Izmir, 35040, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 126190
Izmir, 35110, Turkey (Türkiye)
Communal non-profit enterprise Regional Center of Oncology /ID# 128221
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
Cherkassy Regional Onc Ctr /ID# 128222
Cherkasy, 18000, Ukraine
Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220
Chernivtsi, 58013, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217
Dnipro, 49102, Ukraine
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218
Lviv, 79031, Ukraine
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223
Poltava, 36011, Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219
Sumy, 40022, Ukraine
Cheltenham General Hospital /ID# 125692
Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
Guy's and St Thomas' NHS Found /ID# 125694
London, London, City of, SE1 9RT, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 125697
Norwich, Norfolk, NR4 7UY, United Kingdom
Betsi Cadwaladr Univ Health Bo /ID# 127177
Bangor, LL57 2PW, United Kingdom
North Devon District Hospital /ID# 125689
Barnstaple, ES31 4JB, United Kingdom
The Royal Bournemouth Hospital /ID# 125690
Bournemouth, BH7 7DW, United Kingdom
East Kent Hosp Univ NHS Trust /ID# 125698
Canterbury, CT1 3NG, United Kingdom
Gartnavel General Hospital /ID# 126233
Glasgow, G12 0YN, United Kingdom
James Paget University Hosp /ID# 125696
Great Yarmouth, NR31 6LA, United Kingdom
Charing Cross Hospital /ID# 125688
London, W6 8RF, United Kingdom
Maidstone Hospital /ID# 125693
Maidstone, ME16 9QQ, United Kingdom
The Clatterbridge Cancer Ctr /ID# 125695
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (1)
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.
PMID: 34436928DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 8, 2014
Study Start
April 10, 2014
Primary Completion
January 3, 2017
Study Completion
November 20, 2019
Last Updated
November 17, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- 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.
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.