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Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

Primary Purpose

Non-squamous Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Paclitaxel

Carboplatin

Cisplatin

Veliparib

Pemetrexed

About this trial

This is an interventional treatment trial for Non-squamous Non-small Cell Lung Cancer focused on measuring veliparib, carboplatin, paclitaxel, cisplatin, pemetrexed, Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP), Metastatic, Non-squamous, Non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject must be ≥ 18 years of age with life expectancy > 12 weeks.
Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed 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 squamous NSCLC, or an untreated 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 or chemoradiotherapy for NSCLC.

Sites / Locations

Clearview Cancer Institute /ID# 131434
University of South Alabama /ID# 131518
Highlands Oncology Group /ID# 131250
CBCC Global Research, Inc. at /ID# 132709
California Cancer Assoc. R&E /ID# 131392
California Cancer Assoc. R&E /ID# 131949
LA Hem-Oncology Med Group /ID# 131639
St Jude Hospital dba St Joseph /ID# 132943
Icri /Id# 132942
University of Florida - Archer /ID# 132408
NorthShore University HealthSystem - Evanston Hospital /ID# 130200
Goshen Center for Cancer Care /ID# 130216
University of Louisville /ID# 130217
Cancer Center of Acadiana /ID# 133611
Henry Ford Health System /ID# 130234
Herbert Herman Cancer Center /ID# 130239
Washington University-School of Medicine /ID# 131651
MD Anderson Cancer Center at Cooper - Camden /ID# 131490
Gabrail Cancer Center Research /ID# 130205
Univ Oklahoma HSC /ID# 132888
Albert Einstein Medical Center /ID# 134498
Allegheny General Hospital /ID# 134049
The Jones Clinic, PC /ID# 130215
UT Southwestern Medical Center /ID# 130236
Univ Texas HSC San Antonio /ID# 132972
Coiba /Id# 132153
Centro Investigacion Pergamino /ID# 132152
Hospital Britanico /ID# 134874
Instituto de Oncologia de Rosa /ID# 132150
St George Hospital /ID# 132481
Southern Medical Day Care Ctr /ID# 132482
Flinders Centre for Innovation /ID# 134288
Royal Hobart Hospital /ID# 132477
Qe Ii Hsc /Id# 133408
Victoria Hospital /ID# 132161
Windsor Regional Hospital /ID# 135989
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155
Krajska nemocnice Liberec a.s. /ID# 132694
Univ Hosp Ostrava-Poruba /ID# 132690
Multiscan s.r.o. /ID# 132689
Vseobecna Fakultni Nemocnice /ID# 135118
Odense Universitets Hospital /ID# 131912
Satakunnan Sairaanhoitopiiri /ID# 133632
Vaasa Central Hospital /ID# 131930
Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927
Lungen Clinic Grosshansdorf /ID# 131928
Univ Klinik Eppendorf Hamburg /ID# 131926
Klinik Loewenstein GmbH /ID# 131925
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441
Orszagos Koranyi Pulmonologiai Intezet /ID# 132738
Debreceni Egyetem Klinikai Kozpont /ID# 132742
Koch Robert Hospital /ID# 133440
Veszprem Megyei Tudogyogyintez /ID# 132739
Petz Aladar Megyei Oktato Korh /ID# 132741
Matrahaza Gyogyintezet /ID# 132743
Assaf Harofeh Medical Center /ID# 132830
Shaare Zedek Medical Center /ID# 132834
Meir Medical Center /ID# 132832
Sheba Medical Center /ID# 132833
Aichi Cancer Center Hospital /ID# 134129
Kurume University Hospital /ID# 134117
Hokkaido University Hospital /ID# 134123
Kanagawa Cardiovascular and Respiratory Center /ID# 134127
Sendai Kousei Hospital /ID# 135491
Kindai University Hospital /ID# 134112
Osaka City General Hospital /ID# 134115
National Cancer Center Hospital /ID# 135129
The Cancer Institute Hospital Of JFCR /ID# 135492
Yamaguchi - Ube Medical Center /ID# 135284
Hiroshima Citizens Hospital /ID# 135130
Kishiwada City Hospital /ID# 136548
Dong-A University Hospital /ID# 131609
Seoul National Univ Bundang ho /ID# 131610
Inha University Hospital /ID# 147924
Chonnam National University Hospital /ID# 131612
Samsung Medical Center /ID# 132471
Chungbuk National Univ Hosp /ID# 131611
Vrije Universiteit Medisch Centrum /ID# 131967
Catharina Ziekenhuis /ID# 131966
Ziekenhuis St. Jansdal /ID# 131965
St. Antonius Ziekenhuis /ID# 133635
Jeroen Bosch Ziekenhuis /ID# 131968
Canterbury District Health Boa /ID# 132469
Wellington Hospital (Capital and Coast District Health Board) /ID# 132470
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085
Sverdlovsk Regional Oncology Center Dispensary /ID# 132375
archangel Clinical Oncology /ID# 132376
Moscow Regional Onc Dispensary /ID# 132381
Belgorod Oncology Dispensary /ID# 142638
Moscow Res Onc Inst Hertsen /ID# 132370
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087
Orenburg Regional Clinical Onc /ID# 132371
Strategic medical systems LLC /ID# 206383
Ogarev Mordovia State Univ /ID# 132377
LLC BioEq Ltd. /ID# 132372
N.N. Petrov Research Inst Onc /ID# 137084
GVI Oncology /ID# 133268
Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775
Mary Potter Oncology Centre /ID# 131776
The Oncology Centre /ID# 131773
Netcare Oncology Intervent Ctr /ID# 131777
Cape Town Oncology Trials /ID# 132734
GVI Rondebosch Oncology Centre /ID# 132732
Sandton Oncology Medical Group /ID# 131774
Hospital Duran i Reynals /ID# 132879
Hospital Universitario Fundacion Alcorcon /ID# 132909
Hospital General Universitario Alicante /ID# 132881
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876
Hospital Universitario Vall d'Hebron /ID# 132871
MD Anderson Madrid /ID# 132905
Hospital Universitario La Paz /ID# 132870
Hospital Universitario HM Sanchinarro /ID# 132869
Hospital Clinico Universitario de Valencia /ID# 132873
China Medical University Hosp /ID# 131870
Dalin Tzu Chi General Hospital /ID# 131872
Taipei Medical University Hospital /ID# 133817
Taipei Veterans General Hosp /ID# 131871
Hacettepe University Medical Faculty /ID# 131913
Ankara Univ Medical Faculty /ID# 131914
Uludag University Medical Faculty /ID# 131915
Dicle Universitesi Tip /ID# 136570
Gaziantep Universitesi Med /ID# 131917
Dr. Suat Seren Gogus Has /ID# 136568
Inonu University /ID# 136569
Leicester Royal Infirmary /ID# 133930
Cheltenham General Hospital /ID# 131951
Norfolk and Norwich Univ Hosp /ID# 131953
Royal United Hospitals Bath /ID# 132851
Belfast City Hospital /ID# 132858
Heart of England NHS Foundation Trust /ID# 132855
Royal Blackburn Hospital /ID# 132853
Colchester General Hospital /ID# 133929
Castle Hill Hospital /ID# 135489
Scunthorpe General Hospital /ID# 133931
James Paget University Hosp /ID# 131954
Royal Gwent Hospital /ID# 133935
Huddersfield Royal Infirmary /ID# 132854
Charing Cross Hospital /ID# 131959
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661
York Hospital /ID# 132859

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Veliparib + Carboplatin + Paclitaxel

Investigator's Choice Chemotherapy

Arm Description

Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles. After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles: Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m² Cisplatin 75 mg/m² + pemetrexed 500 mg/m² Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m² After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.

Outcomes

Primary Outcome Measures

Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup

Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.

Secondary Outcome Measures

Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first. PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.

Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed. CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.

Overall Survival in All Participants

Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.

Progression Free Survival (PFS) in All Participants

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first. PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.

Objective Response Rate (ORR) in All Participants

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed. CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.

Full Information

NCT ID

NCT02264990

First Posted

October 9, 2014

Last Updated

February 8, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02264990

Brief Title

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

Official Title

A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 30, 2014 (Actual)

Primary Completion Date

November 14, 2019 (Actual)

Study Completion Date

February 21, 2020 (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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-squamous Non-small Cell Lung Cancer

Keywords

veliparib, carboplatin, paclitaxel, cisplatin, pemetrexed, Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP), Metastatic, Non-squamous, Non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

595 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Veliparib + Carboplatin + Paclitaxel

Arm Type

Experimental

Arm Description

Arm Title

Investigator's Choice Chemotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Administered by Intravenous infusion on Day 1 of each 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Administered by Intravenous infusion on Day 1 of each 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Administered by Intravenous infusion on Day 1 of each 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Veliparib

Other Intervention Name(s)

ABT-888

Intervention Description

Oral capsule, administered twice daily for 7 days in each 21-day cycle

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Administered by Intravenous infusion on Day 1 of each 21-day cycle

Primary Outcome Measure Information:

Title

Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup

Description

Time Frame

From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup

Description

Time Frame

From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Title

Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup

Description

Time Frame

Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.

Title

Overall Survival in All Participants

Description

Time Frame

From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Title

Progression Free Survival (PFS) in All Participants

Description

Time Frame

From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Title

Objective Response Rate (ORR) in All Participants

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject must be ≥ 18 years of age with life expectancy > 12 weeks. Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers. Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening. Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed 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 squamous NSCLC, or an untreated 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 or chemoradiotherapy for NSCLC.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Clearview Cancer Institute /ID# 131434

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Facility Name

University of South Alabama /ID# 131518

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36617

Country

United States

Facility Name

Highlands Oncology Group /ID# 131250

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Facility Name

CBCC Global Research, Inc. at /ID# 132709

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

California Cancer Assoc. R&E /ID# 131392

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

California Cancer Assoc. R&E /ID# 131949

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

LA Hem-Oncology Med Group /ID# 131639

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

St Jude Hospital dba St Joseph /ID# 132943

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Icri /Id# 132942

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

University of Florida - Archer /ID# 132408

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

NorthShore University HealthSystem - Evanston Hospital /ID# 130200

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Goshen Center for Cancer Care /ID# 130216

City

Goshen

State/Province

Indiana

ZIP/Postal Code

46526

Country

United States

Facility Name

University of Louisville /ID# 130217

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Cancer Center of Acadiana /ID# 133611

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70503

Country

United States

Facility Name

Henry Ford Health System /ID# 130234

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Herbert Herman Cancer Center /ID# 130239

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

Washington University-School of Medicine /ID# 131651

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

MD Anderson Cancer Center at Cooper - Camden /ID# 131490

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

Gabrail Cancer Center Research /ID# 130205

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Univ Oklahoma HSC /ID# 132888

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Albert Einstein Medical Center /ID# 134498

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Facility Name

Allegheny General Hospital /ID# 134049

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

The Jones Clinic, PC /ID# 130215

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

UT Southwestern Medical Center /ID# 130236

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-7208

Country

United States

Facility Name

Univ Texas HSC San Antonio /ID# 132972

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Coiba /Id# 132153

City

Berazategui, Buenos Aires

ZIP/Postal Code

1884

Country

Argentina

Facility Name

Centro Investigacion Pergamino /ID# 132152

City

Pergamino

ZIP/Postal Code

2700

Country

Argentina

Facility Name

Hospital Britanico /ID# 134874

City

Rosario, Santa FE

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Instituto de Oncologia de Rosa /ID# 132150

City

Rosario, Santa FE

ZIP/Postal Code

2000

Country

Argentina

Facility Name

St George Hospital /ID# 132481

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Southern Medical Day Care Ctr /ID# 132482

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

Flinders Centre for Innovation /ID# 134288

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

Royal Hobart Hospital /ID# 132477

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Qe Ii Hsc /Id# 133408

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Victoria Hospital /ID# 132161

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Windsor Regional Hospital /ID# 135989

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N9C 3Z4

Country

Canada

Facility Name

CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G6V 3Z1

Country

Canada

Facility Name

Krajska nemocnice Liberec a.s. /ID# 132694

City

Liberec

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Univ Hosp Ostrava-Poruba /ID# 132690

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Multiscan s.r.o. /ID# 132689

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Vseobecna Fakultni Nemocnice /ID# 135118

City

Prague

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Odense Universitets Hospital /ID# 131912

City

Odense C

State/Province

Syddanmark

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Satakunnan Sairaanhoitopiiri /ID# 133632

City

Pori

ZIP/Postal Code

28500

Country

Finland

Facility Name

Vaasa Central Hospital /ID# 131930

City

Vaasa

ZIP/Postal Code

65130

Country

Finland

Facility Name

Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Lungen Clinic Grosshansdorf /ID# 131928

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Univ Klinik Eppendorf Hamburg /ID# 131926

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Klinik Loewenstein GmbH /ID# 131925

City

Löwenstein

ZIP/Postal Code

74245

Country

Germany

Facility Name

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Orszagos Koranyi Pulmonologiai Intezet /ID# 132738

City

Budapest XII

State/Province

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont /ID# 132742

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Koch Robert Hospital /ID# 133440

City

Edelény

ZIP/Postal Code

3780

Country

Hungary

Facility Name

Veszprem Megyei Tudogyogyintez /ID# 132739

City

Farkasgyepu

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Petz Aladar Megyei Oktato Korh /ID# 132741

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Matrahaza Gyogyintezet /ID# 132743

City

Kékesteto

ZIP/Postal Code

3233

Country

Hungary

Facility Name

Assaf Harofeh Medical Center /ID# 132830

City

Be'er Ya'akov

ZIP/Postal Code

70300

Country

Israel

Facility Name

Shaare Zedek Medical Center /ID# 132834

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Meir Medical Center /ID# 132832

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Sheba Medical Center /ID# 132833

City

Ramat Gan

ZIP/Postal Code

5239424

Country

Israel

Facility Name

Aichi Cancer Center Hospital /ID# 134129

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Kurume University Hospital /ID# 134117

City

Kurume-shi

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Hokkaido University Hospital /ID# 134123

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Kanagawa Cardiovascular and Respiratory Center /ID# 134127

City

Yokohama-shi

State/Province

Kanagawa

ZIP/Postal Code

236-0051

Country

Japan

Facility Name

Sendai Kousei Hospital /ID# 135491

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

980-0873

Country

Japan

Facility Name

Kindai University Hospital /ID# 134112

City

Osaka-sayama-shi

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Osaka City General Hospital /ID# 134115

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

National Cancer Center Hospital /ID# 135129

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

The Cancer Institute Hospital Of JFCR /ID# 135492

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Yamaguchi - Ube Medical Center /ID# 135284

City

Ube-shi

State/Province

Yamaguchi

ZIP/Postal Code

755-0241

Country

Japan

Facility Name

Hiroshima Citizens Hospital /ID# 135130

City

Hiroshima

ZIP/Postal Code

730-8518

Country

Japan

Facility Name

Kishiwada City Hospital /ID# 136548

City

Kishiwada

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Dong-A University Hospital /ID# 131609

City

Busan

State/Province

Busan Gwang Yeogsi

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Seoul National Univ Bundang ho /ID# 131610

City

Seongnam

State/Province

Gyeonggido

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Inha University Hospital /ID# 147924

City

Jung-gu

State/Province

Incheon Gwang Yeogsi

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital /ID# 131612

City

Gwangju

State/Province

Jeonranamdo

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Samsung Medical Center /ID# 132471

City

Seoul

State/Province

Seoul Teugbyeolsi

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Chungbuk National Univ Hosp /ID# 131611

City

Cheongju

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Vrije Universiteit Medisch Centrum /ID# 131967

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Catharina Ziekenhuis /ID# 131966

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Ziekenhuis St. Jansdal /ID# 131965

City

Harderwijk

ZIP/Postal Code

3844 DG

Country

Netherlands

Facility Name

St. Antonius Ziekenhuis /ID# 133635

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Jeroen Bosch Ziekenhuis /ID# 131968

City

S Hertogenbosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

Canterbury District Health Boa /ID# 132469

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Wellington Hospital (Capital and Coast District Health Board) /ID# 132470

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085

City

Moscow

State/Province

Moskva

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Sverdlovsk Regional Oncology Center Dispensary /ID# 132375

City

Ekaterinburg

State/Province

Sverdlovskaya Oblast

ZIP/Postal Code

620043

Country

Russian Federation

Facility Name

archangel Clinical Oncology /ID# 132376

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Moscow Regional Onc Dispensary /ID# 132381

City

Balashikha

ZIP/Postal Code

143900

Country

Russian Federation

Facility Name

Belgorod Oncology Dispensary /ID# 142638

City

Belgorod

ZIP/Postal Code

308010

Country

Russian Federation

Facility Name

Moscow Res Onc Inst Hertsen /ID# 132370

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087

City

Murmansk

ZIP/Postal Code

183047

Country

Russian Federation

Facility Name

Orenburg Regional Clinical Onc /ID# 132371

City

Orenburg

ZIP/Postal Code

460021

Country

Russian Federation

Facility Name

Strategic medical systems LLC /ID# 206383

City

Sankt-Peterburg

ZIP/Postal Code

192148

Country

Russian Federation

Facility Name

Ogarev Mordovia State Univ /ID# 132377

City

Saransk

ZIP/Postal Code

430005

Country

Russian Federation

Facility Name

LLC BioEq Ltd. /ID# 132372

City

St. Petersburg

ZIP/Postal Code

197342

Country

Russian Federation

Facility Name

N.N. Petrov Research Inst Onc /ID# 137084

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

GVI Oncology /ID# 133268

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6006

Country

South Africa

Facility Name

Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0044

Country

South Africa

Facility Name

Mary Potter Oncology Centre /ID# 131776

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

The Oncology Centre /ID# 131773

City

Durban

State/Province

Kwazulu-Natal

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Netcare Oncology Intervent Ctr /ID# 131777

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7460

Country

South Africa

Facility Name

Cape Town Oncology Trials /ID# 132734

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7570

Country

South Africa

Facility Name

GVI Rondebosch Oncology Centre /ID# 132732

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Sandton Oncology Medical Group /ID# 131774

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Hospital Duran i Reynals /ID# 132879

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Universitario Fundacion Alcorcon /ID# 132909

City

Alcorcon

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital General Universitario Alicante /ID# 132881

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

Hospital Universitario Vall d'Hebron /ID# 132871

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

MD Anderson Madrid /ID# 132905

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Hospital Universitario La Paz /ID# 132870

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Universitario HM Sanchinarro /ID# 132869

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Clinico Universitario de Valencia /ID# 132873

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

China Medical University Hosp /ID# 131870

City

Taichung City

State/Province

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Dalin Tzu Chi General Hospital /ID# 131872

City

Dalin Township

ZIP/Postal Code

622

Country

Taiwan

Facility Name

Taipei Medical University Hospital /ID# 133817

City

Taipei City

ZIP/Postal Code

11031

Country

Taiwan

Facility Name

Taipei Veterans General Hosp /ID# 131871

City

Taipei City

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Hacettepe University Medical Faculty /ID# 131913

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara Univ Medical Faculty /ID# 131914

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Uludag University Medical Faculty /ID# 131915

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Dicle Universitesi Tip /ID# 136570

City

Diyarbakir

ZIP/Postal Code

21200

Country

Turkey

Facility Name

Gaziantep Universitesi Med /ID# 131917

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Dr. Suat Seren Gogus Has /ID# 136568

City

Izmir

ZIP/Postal Code

35110

Country

Turkey

Facility Name

Inonu University /ID# 136569

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

Leicester Royal Infirmary /ID# 133930

City

Leicester

State/Province

England

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Cheltenham General Hospital /ID# 131951

City

Cheltenham

State/Province

Gloucestershire

ZIP/Postal Code

GL53 7AN

Country

United Kingdom

Facility Name

Norfolk and Norwich Univ Hosp /ID# 131953

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Royal United Hospitals Bath /ID# 132851

City

Bath

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

Belfast City Hospital /ID# 132858

City

Belfast

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

Facility Name

Heart of England NHS Foundation Trust /ID# 132855

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Royal Blackburn Hospital /ID# 132853

City

Blackburn

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

Colchester General Hospital /ID# 133929

City

Colchester

ZIP/Postal Code

CO4 5JL

Country

United Kingdom

Facility Name

Castle Hill Hospital /ID# 135489

City

Cottingham

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Scunthorpe General Hospital /ID# 133931

City

Doncaster

ZIP/Postal Code

DN15 7BH

Country

United Kingdom

Facility Name

James Paget University Hosp /ID# 131954

City

Great Yarmouth

ZIP/Postal Code

NR31 6LA

Country

United Kingdom

Facility Name

Royal Gwent Hospital /ID# 133935

City

Gwent

ZIP/Postal Code

NP20 2UB

Country

United Kingdom

Facility Name

Huddersfield Royal Infirmary /ID# 132854

City

Huddersfield

ZIP/Postal Code

HD3 3EA

Country

United Kingdom

Facility Name

Charing Cross Hospital /ID# 131959

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

York Hospital /ID# 132859

City

York

ZIP/Postal Code

YO31 8HE

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

35331641

Citation

Govindan R, Lind M, Insa A, Khan SA, Uskov D, Tafreshi A, Guclu S, Bar J, Kato T, Lee KH, Nakagawa K, Hansen O, Biesma B, Kundu MG, Dunbar M, He L, Ansell P, Sehgal V, Huang X, Glasgow J, Bach BA. Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer. Clin Lung Cancer. 2022 May;23(3):214-225. doi: 10.1016/j.cllc.2022.01.005. Epub 2022 Feb 4.

Results Reference

derived

Learn more about this trial

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