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
Squamous Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Squamous Non-Small Cell Lung Cancer focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Northeast Arkansas Clinical Ch /ID# 128071
- LA Hem-Oncology Med Group /ID# 129178
- VA Eastern Colorado Healthcare System /ID# 128065
- Holy Cross Hospital /ID# 128074
- University of Florida - Archer /ID# 126476
- Cancer Specialists of North Florida - Southpoint /ID# 127815
- Winship Cancer Institute of Emory University /ID# 124061
- St. Luke's Mountain States Tumor Institute - Boise /ID# 124059
- Illinois Cancer Specialists /ID# 127468
- NorthShore University HealthSystem - Evanston Hospital /ID# 128585
- Ingalls Memorial Hosp /ID# 128360
- Midwestern Regional CTC /ID# 126124
- Goshen Center for Cancer Care /ID# 123875
- Franciscan St. Francis Health /ID# 126678
- Appalachian Regional Healthcare, Inc (ARH) /ID# 128061
- Henry Ford Health System /ID# 126500
- Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156
- Minnesota Oncology Hematology, PA /ID# 127473
- Nebraska Hematology Oncology /ID# 127699
- SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477
- Comprehensive Cancer Ctrs Neva /ID# 127491
- Dartmouth-Hitchcock Medical Center /ID# 128075
- Hackensack Univ Med Ctr /ID# 124057
- Gabrail Cancer Center Research /ID# 127415
- Penn State University and Milton S. Hershey Medical Center /ID# 126676
- The Jones Clinic, PC /ID# 124062
- Texas Oncology - Austin Midtown /ID# 127477
- Texas Oncology - South Austin /ID# 127476
- Parkland Health and Hosp Syste /ID# 128518
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385
- UT Southwestern Medical Center /ID# 127876
- University of Texas MD Anderson Cancer Center /ID# 127946
- Texas Oncology - Paris /ID# 127484
- Texas Oncology - Waco /ID# 127459
- University of Vermont Medical Center /ID# 128064
- Virginia Oncology Associates /ID# 127458
- Northwest Cancer Specialists, P.C. /ID# 127486
- Northwest Cancer Specialists, P.C. /ID# 127488
- Southern Medical Day Care Ctr /ID# 125604
- Sunshine Coast University Hosp /ID# 125608
- The Townsville Hospital /ID# 125609
- Flinders Centre for Innovation /ID# 125605
- The Queen Elizabeth Hospital /ID# 125607
- Barwon Health University Hospital Geelong /ID# 125606
- Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183
- Bobruysk Interdistrict Onco. /ID# 128999
- Brest Regional Hospital /ID# 125955
- State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815
- Mogilev Reg Clin Oncology Dis /ID# 128639
- Vitebsk Reg Clin Onc Disp /ID# 125516
- Hospital Sao Lucas da PUCRS /ID# 127737
- Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738
- Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736
- Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309
- Instituto COI de Educacao e Pesquisa /ID# 127739
- Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737
- University of Calgary /Id# 126326
- Cross Cancer Institute /ID# 126154
- Juravinski Cancer Clinic /ID# 126153
- Victoria Hospital /ID# 126669
- The Ottawa Hospital /ID# 126522
- Princess Margaret Cancer Centre /ID# 126155
- McGill Univ HC /ID# 130431
- CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149
- Iucpq-Ul /Id# 126524
- Klinika za plucne bolesti Jordanovac /ID# 126537
- Klinicki bolnicki centar Osijek /ID# 132214
- Opca bolnica Pula /ID# 126540
- Opca bolnica Dr. Josip Bencevi /ID# 126539
- Fakultni Nemocnice Olomouc /ID# 125820
- Nemocnice Na Plesi s.r.o. /ID# 125817
- Nemocnice Kyjov, prispevkova organizace /ID# 125819
- Nemocnice Novy Jicin /ID# 125818
- Vitkovicka nemocnice a. s. /ID# 127023
- Herlev Hospital /ID# 125995
- Odense Universitets Hospital /ID# 125996
- University of Alexandria /ID# 128337
- Naser Institute for Res & Dev /ID# 129263
- Cairo Uni Hosp Al Kasr El Ainy /ID# 128338
- Cairo Uni Hosp Al Kasr El Ainy /ID# 128340
- North Estonian Medical Centre /ID# 128215
- Tartu University Hospital /ID# 127735
- Helsinki Univ Central Hospital /ID# 125897
- Vaasa Central Hospital /ID# 125896
- CHU Hopital Nord /ID# 128388
- Hopital Haut-Lévêque /ID# 135270
- CHRU Lille - Hôpital Claude Huriez /ID# 126353
- Centre Hospitalier Le Mans /ID# 127902
- Centre Hosp Intercommunal de Creteil /ID# 125922
- CHRU de Brest - Hopital Morvan /ID# 127903
- Centre Antoine Lacassagne /ID# 126360
- Hospital Pontchaillou /ID# 126356
- Hopital Larrey - CHU de Toulouse /ID# 128394
- Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708
- Lungen Clinic Grosshansdorf /ID# 126107
- Klinikum Kassel /ID# 127025
- Klinik Loewenstein GmbH /ID# 126191
- Univ Johannes Gutenberg /ID# 125603
- Papageorgiou General Hospital Thessaloniki /ID# 125876
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879
- Metropolitan Hospital /ID# 125878
- University General Hospital of Heraklion PA.G.N.I /ID# 125877
- CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234
- Orszagos Koranyi Pulmonologiai Intezet /ID# 126112
- Debreceni Egyetem Klinikai Központ /ID# 126119
- Veszprem Megyei Tudogyogyintez /ID# 126121
- Petz Aladar Megyei Oktato Korh /ID# 126110
- Bekes Megyei Pandy Kalman Korhaz /ID# 126117
- Matrahaza Gyogyintezet /ID# 126109
- Fejer Megyei Szent Gyorgy Korh /ID# 126118
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120
- Tudogyogyintezet Toeroekbalint /ID# 126111
- St. James's Hospital /ID# 126177
- Cork University Hospital /ID# 126176
- Beaumont Hospital /ID# 126218
- University Hospital Limerick /ID# 126175
- University Hospital Waterford /ID# 126178
- Assaf Harofeh Medical Center /ID# 127076
- Hadassah University Hospital /ID# 127077
- Meir Medical Center /ID# 127078
- Sheba Medical Center /ID# 127079
- AO San Giuseppe Moscati /ID# 125701
- Istituto Europeo di Oncologia /ID# 125702
- Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704
- A.O.U. San Luigi Gonzaga /ID# 125700
- Azienda Ospedaliero Uni Parma /ID# 125703
- Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699
- Istituto Oncologico del Medite /ID# 132844
- Riga East Clinical Univ Hosp /ID# 125597
- P. Stradins Clinical Univ Hosp /ID# 126322
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176
- National Cancer Institute /ID# 126323
- Centro Estatal de Cancerologia /ID# 127583
- Hospital Angeles Centro Medico /ID# 127620
- Cancerologia de Queretaro S.C. /ID# 125920
- Vrije Universiteit Medisch Centrum /ID# 125578
- Amphia Ziekenhuis /ID# 126466
- Catharina Ziekenhuis /ID# 125577
- Ziekenhuis St. Jansdal /ID# 125576
- Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710
- Jeroen Bosch Ziekenhuis /ID# 125709
- Isala /ID# 125579
- Wellington Hospital (Capital and Coast District Health Board) /ID# 125755
- Haukeland University Hospital /ID# 126338
- Nordland Hospital /ID# 126337
- Sorlandet Sykehus HF /ID# 126341
- Oslo Universitetssykehus, Radiumhospitalet /ID# 126335
- Stavanger University Hospital /ID# 126336
- Sykehuset i Vestfold HF /ID# 126340
- Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548
- Szpital Morski im. PCK /ID# 126547
- NZOZ Magodent Ctr. Med. Ostro /ID# 126545
- Mazowiecki Szpital Onkologiczn /ID# 126546
- Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761
- CCA Braga - Hospital de Braga /ID# 125837
- Ctr Hosp Univ Coimbra, EPE /ID# 125838
- Hospital Pulido Valente /ID# 125835
- IPO Porto FG, EPE /ID# 125836
- Centro Hospitalar de Sao Joao, EPE /ID# 125875
- VA Caribbean Healthcare System /ID# 124562
- Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458
- Sverdlovsk Regional Oncology Center Dispensary /ID# 128457
- Volgograd Regional Clinical Oncology Dispensary /ID# 126350
- Belgorod Oncology Dispensary /ID# 129899
- State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460
- State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461
- Orenburg Regional Clinical Onc /ID# 137474
- Ogarev Mordovia State Univ /ID# 127595
- Smolensk Regional Onc Clin Dis /ID# 127144
- Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143
- Clinical Center Serbia /ID# 128738
- Clinical Center of Nis /ID# 128735
- Institute for Oncology and Rad /ID# 128721
- University Hospital Bezanijska /ID# 128761
- Institute For Pulmonary Diseas /ID# 128737
- Univerzitna Nemocnica Bratislava /ID# 126342
- MEDEON, s.r.o. /ID# 128517
- GVI Oncology /ID# 126102
- Wits Clinical Research Site /ID# 126101
- Sandton Oncology Centre /ID# 126097
- University of Pretoria /ID# 127297
- Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098
- Mary Potter Oncology Centre /ID# 126099
- The Oncology Centre /ID# 126096
- Netcare Oncology Intervent Ctr /ID# 126100
- Cancercare Outeniqua Oncology Unit /ID# 126103
- Hospital Duran i Reynals /ID# 125161
- Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160
- Hospital Universitario Vall d'Hebron /ID# 125159
- Hospital Universitario HM Sanchinarro /ID# 125162
- Hospital Universitario Virgen del Rocio /ID# 125207
- Fundacion Instituto Valenciano Oncologia IVO /ID# 125205
- Gavle Sjukhus /ID# 126444
- Sahlgrenska University Hosp /ID# 129997
- University Hospital Linkoping /ID# 126443
- Karolinska Univ Sjukhuset /ID# 126445
- Kantonsspital St. Gallen /ID# 126349
- Hirslanden Medical Center /ID# 128216
- Inselspital, Universitaetsklinik /ID# 126347
- Spital STS AG /ID# 126348
- Akdeniz University Medical Fac /ID# 126997
- Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186
- Marmara University Medical Fac /ID# 126187
- Ege University Medical Faculty /ID# 126189
- Dr. Suat Seren Gogus Has /ID# 126190
- Communal non-profit enterprise Regional Center of Oncology /ID# 128221
- Cherkassy Regional Onc Ctr /ID# 128222
- Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220
- Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217
- Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218
- Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223
- Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219
- Cheltenham General Hospital /ID# 125692
- Guy's and St Thomas' NHS Found /ID# 125694
- Norfolk and Norwich Univ Hosp /ID# 125697
- Betsi Cadwaladr Univ Health Bo /ID# 127177
- North Devon District Hospital /ID# 125689
- The Royal Bournemouth Hospital /ID# 125690
- East Kent Hosp Univ NHS Trust /ID# 125698
- Gartnavel General Hospital /ID# 126233
- James Paget University Hosp /ID# 125696
- Charing Cross Hospital /ID# 125688
- Maidstone Hospital /ID# 125693
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228
- The Clatterbridge Cancer Ctr /ID# 125695
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Veliparib + Carboplatin + Paclitaxel
Placebo + 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.
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.