Back to resultsStudy Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Primary Purpose
Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Veliparib
Paclitaxel
Placebo to veliparib
Sponsored by
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
Arm Type
Experimental
Placebo Comparator
Arm Label
Veliparib + Carboplatin + Paclitaxel
Placebo + Carboplatin + Paclitaxel
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02106546
Brief Title
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
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2014 (Actual)
Primary Completion Date
January 3, 2017 (Actual)
Study Completion Date
November 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non-Small Cell Lung Cancer
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
970 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Veliparib + Carboplatin + Paclitaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Carboplatin + Paclitaxel
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
Intervention Type
Drug
Intervention Name(s)
Veliparib
Other Intervention Name(s)
ABT-888
Intervention Description
Capsules taken orally twice a day, 12 hours apart.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Intervention Type
Drug
Intervention Name(s)
Placebo to veliparib
Intervention Description
Capsules taken orally twice a day, 12 hours apart.
Primary Outcome Measure Information:
Title
Overall Survival (OS) in current smokers
Description
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.
Time Frame
Up to 3 years from first dose of study drug
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in all subjects
Description
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.
Time Frame
Up to 3 years from first dose of study drug
Title
Progressive-Free Survival (PFS) in current smokers and in all subjects
Description
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.
Time Frame
Up to 3 years from first dose of study drug
Title
Objective Response Rate (ORR) in current smokers and in all subjects
Description
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)
Time Frame
Up to 3 years from first dose of study drug
Other Pre-specified Outcome Measures:
Title
Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).
Time Frame
From Screening (prior to dosing) up to 2 years
Title
Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13).
Time Frame
From Screening (prior to dosing) up to 2 years
Title
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame
From Screening (prior to dosing) up to 2 years
Title
Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)
Time Frame
From Screening (prior to dosing) up to 2 years
Title
Duration of Response
Description
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.
Time Frame
From complete or partial response to disease progression (up to 3 years from randomization).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Northeast Arkansas Clinical Ch /ID# 128071
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
LA Hem-Oncology Med Group /ID# 129178
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
VA Eastern Colorado Healthcare System /ID# 128065
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Holy Cross Hospital /ID# 128074
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida - Archer /ID# 126476
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Cancer Specialists of North Florida - Southpoint /ID# 127815
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Winship Cancer Institute of Emory University /ID# 124061
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Boise /ID# 124059
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Illinois Cancer Specialists /ID# 127468
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
NorthShore University HealthSystem - Evanston Hospital /ID# 128585
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 128360
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Midwestern Regional CTC /ID# 126124
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Goshen Center for Cancer Care /ID# 123875
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Franciscan St. Francis Health /ID# 126678
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Appalachian Regional Healthcare, Inc (ARH) /ID# 128061
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Henry Ford Health System /ID# 126500
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Minnesota Oncology Hematology, PA /ID# 127473
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Nebraska Hematology Oncology /ID# 127699
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Comprehensive Cancer Ctrs Neva /ID# 127491
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 128075
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack Univ Med Ctr /ID# 124057
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 127415
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 126676
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
The Jones Clinic, PC /ID# 124062
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology - Austin Midtown /ID# 127477
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology - South Austin /ID# 127476
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Parkland Health and Hosp Syste /ID# 128518
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 127876
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 127946
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Paris /ID# 127484
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
Facility Name
Texas Oncology - Waco /ID# 127459
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
University of Vermont Medical Center /ID# 128064
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1473
Country
United States
Facility Name
Virginia Oncology Associates /ID# 127458
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Cancer Specialists, P.C. /ID# 127486
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Northwest Cancer Specialists, P.C. /ID# 127488
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Southern Medical Day Care Ctr /ID# 125604
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Sunshine Coast University Hosp /ID# 125608
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
The Townsville Hospital /ID# 125609
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Flinders Centre for Innovation /ID# 125605
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 125607
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Barwon Health University Hospital Geelong /ID# 125606
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Bobruysk Interdistrict Onco. /ID# 128999
City
Bobruisk
ZIP/Postal Code
213825
Country
Belarus
Facility Name
Brest Regional Hospital /ID# 125955
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Mogilev Reg Clin Oncology Dis /ID# 128639
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
Vitebsk Reg Clin Onc Disp /ID# 125516
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Hospital Sao Lucas da PUCRS /ID# 127737
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Instituto COI de Educacao e Pesquisa /ID# 127739
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737
City
Sao Paulo
ZIP/Postal Code
01509-000
Country
Brazil
Facility Name
University of Calgary /Id# 126326
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Cross Cancer Institute /ID# 126154
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Juravinski Cancer Clinic /ID# 126153
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Victoria Hospital /ID# 126669
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital /ID# 126522
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre /ID# 126155
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill Univ HC /ID# 130431
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Iucpq-Ul /Id# 126524
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Klinika za plucne bolesti Jordanovac /ID# 126537
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Osijek /ID# 132214
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Opca bolnica Pula /ID# 126540
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Opca bolnica Dr. Josip Bencevi /ID# 126539
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
Fakultni Nemocnice Olomouc /ID# 125820
City
Olomouc
State/Province
Olomoucky Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Nemocnice Na Plesi s.r.o. /ID# 125817
City
Nová Ves pod Pleší
State/Province
Pribram
ZIP/Postal Code
262 04
Country
Czechia
Facility Name
Nemocnice Kyjov, prispevkova organizace /ID# 125819
City
Kyjov
ZIP/Postal Code
697 01
Country
Czechia
Facility Name
Nemocnice Novy Jicin /ID# 125818
City
Nový Jičín 1
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Vitkovicka nemocnice a. s. /ID# 127023
City
Ostrava
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Herlev Hospital /ID# 125995
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitets Hospital /ID# 125996
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
University of Alexandria /ID# 128337
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Naser Institute for Res & Dev /ID# 129263
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Facility Name
Cairo Uni Hosp Al Kasr El Ainy /ID# 128338
City
Cairo
ZIP/Postal Code
11956
Country
Egypt
Facility Name
Cairo Uni Hosp Al Kasr El Ainy /ID# 128340
City
Cairo
ZIP/Postal Code
11956
Country
Egypt
Facility Name
North Estonian Medical Centre /ID# 128215
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital /ID# 127735
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Helsinki Univ Central Hospital /ID# 125897
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Vaasa Central Hospital /ID# 125896
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Facility Name
CHU Hopital Nord /ID# 128388
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13915
Country
France
Facility Name
Hopital Haut-Lévêque /ID# 135270
City
Pessac CEDEX
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hôpital Claude Huriez /ID# 126353
City
Lille CEDEX
State/Province
Hauts-de-France
ZIP/Postal Code
59045
Country
France
Facility Name
Centre Hospitalier Le Mans /ID# 127902
City
Le Mans CEDEX 9
State/Province
Sarthe
ZIP/Postal Code
72037
Country
France
Facility Name
Centre Hosp Intercommunal de Creteil /ID# 125922
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94000
Country
France
Facility Name
CHRU de Brest - Hopital Morvan /ID# 127903
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Antoine Lacassagne /ID# 126360
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hospital Pontchaillou /ID# 126356
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Larrey - CHU de Toulouse /ID# 128394
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Lungen Clinic Grosshansdorf /ID# 126107
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Klinikum Kassel /ID# 127025
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Klinik Loewenstein GmbH /ID# 126191
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Univ Johannes Gutenberg /ID# 125603
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Papageorgiou General Hospital Thessaloniki /ID# 125876
City
Nea Efkarpia
State/Province
Thessaloniki
ZIP/Postal Code
54603
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan Hospital /ID# 125878
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 125877
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Orszagos Koranyi Pulmonologiai Intezet /ID# 126112
City
Budapest XII
State/Province
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ /ID# 126119
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Veszprem Megyei Tudogyogyintez /ID# 126121
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korh /ID# 126110
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz /ID# 126117
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Matrahaza Gyogyintezet /ID# 126109
City
Kékesteto
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korh /ID# 126118
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Tudogyogyintezet Toeroekbalint /ID# 126111
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
St. James's Hospital /ID# 126177
City
Dublin 8
State/Province
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Facility Name
Cork University Hospital /ID# 126176
City
Cork
ZIP/Postal Code
T12 E8YV
Country
Ireland
Facility Name
Beaumont Hospital /ID# 126218
City
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
University Hospital Limerick /ID# 126175
City
Limerick
ZIP/Postal Code
V94F858
Country
Ireland
Facility Name
University Hospital Waterford /ID# 126178
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Assaf Harofeh Medical Center /ID# 127076
City
Be'er Ya'akov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Hadassah University Hospital /ID# 127077
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center /ID# 127078
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center /ID# 127079
City
Ramat Gan
ZIP/Postal Code
5239424
Country
Israel
Facility Name
AO San Giuseppe Moscati /ID# 125701
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Istituto Europeo di Oncologia /ID# 125702
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga /ID# 125700
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliero Uni Parma /ID# 125703
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699
City
Perugia
ZIP/Postal Code
06100
Country
Italy
Facility Name
Istituto Oncologico del Medite /ID# 132844
City
Viagrande
ZIP/Postal Code
95029
Country
Italy
Facility Name
Riga East Clinical Univ Hosp /ID# 125597
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
P. Stradins Clinical Univ Hosp /ID# 126322
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176
City
Kovno
State/Province
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
National Cancer Institute /ID# 126323
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
Centro Estatal de Cancerologia /ID# 127583
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Hospital Angeles Centro Medico /ID# 127620
City
San Luis Potosí
ZIP/Postal Code
78216
Country
Mexico
Facility Name
Cancerologia de Queretaro S.C. /ID# 125920
City
Santiago de Querétaro
ZIP/Postal Code
76178
Country
Mexico
Facility Name
Vrije Universiteit Medisch Centrum /ID# 125578
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amphia Ziekenhuis /ID# 126466
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Catharina Ziekenhuis /ID# 125577
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Ziekenhuis St. Jansdal /ID# 125576
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis /ID# 125709
City
S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Isala /ID# 125579
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Wellington Hospital (Capital and Coast District Health Board) /ID# 125755
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Haukeland University Hospital /ID# 126338
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Nordland Hospital /ID# 126337
City
Bodø
ZIP/Postal Code
8005
Country
Norway
Facility Name
Sorlandet Sykehus HF /ID# 126341
City
Kristiansand
ZIP/Postal Code
4615
Country
Norway
Facility Name
Oslo Universitetssykehus, Radiumhospitalet /ID# 126335
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Stavanger University Hospital /ID# 126336
City
Stavanger
ZIP/Postal Code
4068
Country
Norway
Facility Name
Sykehuset i Vestfold HF /ID# 126340
City
Tonsberg
ZIP/Postal Code
3116
Country
Norway
Facility Name
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Szpital Morski im. PCK /ID# 126547
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
NZOZ Magodent Ctr. Med. Ostro /ID# 126545
City
Warsaw
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Mazowiecki Szpital Onkologiczn /ID# 126546
City
Wieliszew
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
CCA Braga - Hospital de Braga /ID# 125837
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Ctr Hosp Univ Coimbra, EPE /ID# 125838
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Pulido Valente /ID# 125835
City
Lisbon
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
IPO Porto FG, EPE /ID# 125836
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, EPE /ID# 125875
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
VA Caribbean Healthcare System /ID# 124562
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Center Dispensary /ID# 128457
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Dispensary /ID# 126350
City
Volgograd
State/Province
Volgogradskaya Oblast
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Belgorod Oncology Dispensary /ID# 129899
City
Belgorod
ZIP/Postal Code
308010
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Onc /ID# 137474
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Ogarev Mordovia State Univ /ID# 127595
City
Saransk
ZIP/Postal Code
430005
Country
Russian Federation
Facility Name
Smolensk Regional Onc Clin Dis /ID# 127144
City
Smolensk
ZIP/Postal Code
214009
Country
Russian Federation
Facility Name
Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Clinical Center Serbia /ID# 128738
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Nis /ID# 128735
City
NIS
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institute for Oncology and Rad /ID# 128721
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital Bezanijska /ID# 128761
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Institute For Pulmonary Diseas /ID# 128737
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Univerzitna Nemocnica Bratislava /ID# 126342
City
Bratislava
ZIP/Postal Code
821 01
Country
Slovakia
Facility Name
MEDEON, s.r.o. /ID# 128517
City
Pieštany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
GVI Oncology /ID# 126102
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6006
Country
South Africa
Facility Name
Wits Clinical Research Site /ID# 126101
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Sandton Oncology Centre /ID# 126097
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2199
Country
South Africa
Facility Name
University of Pretoria /ID# 127297
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0044
Country
South Africa
Facility Name
Mary Potter Oncology Centre /ID# 126099
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
The Oncology Centre /ID# 126096
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Netcare Oncology Intervent Ctr /ID# 126100
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Cancercare Outeniqua Oncology Unit /ID# 126103
City
George
State/Province
Western Cape
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Hospital Duran i Reynals /ID# 125161
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 125159
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 125162
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 125207
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Fundacion Instituto Valenciano Oncologia IVO /ID# 125205
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Gavle Sjukhus /ID# 126444
City
Gavle
ZIP/Postal Code
803 24
Country
Sweden
Facility Name
Sahlgrenska University Hosp /ID# 129997
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
University Hospital Linkoping /ID# 126443
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Karolinska Univ Sjukhuset /ID# 126445
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Kantonsspital St. Gallen /ID# 126349
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Hirslanden Medical Center /ID# 128216
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
Facility Name
Inselspital, Universitaetsklinik /ID# 126347
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Spital STS AG /ID# 126348
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Akdeniz University Medical Fac /ID# 126997
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Marmara University Medical Fac /ID# 126187
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Ege University Medical Faculty /ID# 126189
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Dr. Suat Seren Gogus Has /ID# 126190
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Communal non-profit enterprise Regional Center of Oncology /ID# 128221
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Cherkassy Regional Onc Ctr /ID# 128222
City
Cherkasy
ZIP/Postal Code
18000
Country
Ukraine
Facility Name
Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Cheltenham General Hospital /ID# 125692
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Found /ID# 125694
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Norfolk and Norwich Univ Hosp /ID# 125697
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Betsi Cadwaladr Univ Health Bo /ID# 127177
City
Bangor
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
North Devon District Hospital /ID# 125689
City
Barnstaple
ZIP/Postal Code
ES31 4JB
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital /ID# 125690
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
East Kent Hosp Univ NHS Trust /ID# 125698
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Gartnavel General Hospital /ID# 126233
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
James Paget University Hosp /ID# 125696
City
Great Yarmouth
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Charing Cross Hospital /ID# 125688
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Maidstone Hospital /ID# 125693
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Ctr /ID# 125695
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34436928
Citation
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.
Results Reference
derived
Learn more about this trial
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
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