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
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
2 other identifiers
interventional
595
20 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2014
Longer than P75 for phase_3
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2014
CompletedFirst Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedResults Posted
Study results publicly available
February 26, 2021
CompletedFebruary 26, 2021
February 1, 2021
5.1 years
October 9, 2014
February 8, 2021
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (5)
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
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.
Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
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.
Overall Survival in All Participants
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.
Progression Free Survival (PFS) in All Participants
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.
Objective Response Rate (ORR) in All Participants
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 6.7 and 5.9 months in each group, respectively.
Study Arms (2)
Veliparib + Carboplatin + Paclitaxel
EXPERIMENTALParticipants 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.
Investigator's Choice Chemotherapy
ACTIVE COMPARATORParticipants 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.
Interventions
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Oral capsule, administered twice daily for 7 days in each 21-day cycle
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
- Subject has a known hypersensitivity to platinum compounds.
- Subject has peripheral neuropathy ≥ grade 2.
- Subject has 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (140)
Clearview Cancer Institute /ID# 131434
Huntsville, Alabama, 35805, United States
University of South Alabama /ID# 131518
Mobile, Alabama, 36617, United States
Highlands Oncology Group /ID# 131250
Springdale, Arkansas, 72762, United States
CBCC Global Research, Inc. at /ID# 132709
Bakersfield, California, 93309, United States
California Cancer Assoc. R&E /ID# 131392
Encinitas, California, 92024, United States
California Cancer Assoc. R&E /ID# 131949
Encinitas, California, 92024, United States
LA Hem-Oncology Med Group /ID# 131639
Los Angeles, California, 90017, United States
St Jude Hospital dba St Joseph /ID# 132943
Santa Rosa, California, 95403, United States
Icri /Id# 132942
Whittier, California, 90603, United States
University of Florida - Archer /ID# 132408
Gainesville, Florida, 32610, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 130200
Evanston, Illinois, 60201, United States
Goshen Center for Cancer Care /ID# 130216
Goshen, Indiana, 46526, United States
University of Louisville /ID# 130217
Louisville, Kentucky, 40202, United States
Cancer Center of Acadiana /ID# 133611
Lafayette, Louisiana, 70503, United States
Henry Ford Health System /ID# 130234
Detroit, Michigan, 48202, United States
Herbert Herman Cancer Center /ID# 130239
Lansing, Michigan, 48912, United States
Washington University-School of Medicine /ID# 131651
St Louis, Missouri, 63110, United States
MD Anderson Cancer Center at Cooper - Camden /ID# 131490
Camden, New Jersey, 08103, United States
Gabrail Cancer Center Research /ID# 130205
Canton, Ohio, 44718, United States
Univ Oklahoma HSC /ID# 132888
Oklahoma City, Oklahoma, 73104, United States
Albert Einstein Medical Center /ID# 134498
Philadelphia, Pennsylvania, 19141, United States
Allegheny General Hospital /ID# 134049
Pittsburgh, Pennsylvania, 15212, United States
The Jones Clinic, PC /ID# 130215
Germantown, Tennessee, 38138, United States
UT Southwestern Medical Center /ID# 130236
Dallas, Texas, 75390-7208, United States
Univ Texas HSC San Antonio /ID# 132972
San Antonio, Texas, 78229, United States
Coiba /Id# 132153
Berazategui, Buenos Aires, 1884, Argentina
Centro Investigacion Pergamino /ID# 132152
Pergamino, 2700, Argentina
Hospital Britanico /ID# 134874
Rosario, Santa FE, 2000, Argentina
Instituto de Oncologia de Rosa /ID# 132150
Rosario, Santa FE, 2000, Argentina
St George Hospital /ID# 132481
Kogarah, New South Wales, 2217, Australia
Southern Medical Day Care Ctr /ID# 132482
Wollongong, New South Wales, 2500, Australia
Flinders Centre for Innovation /ID# 134288
Bedford Park, South Australia, 5042, Australia
Royal Hobart Hospital /ID# 132477
Hobart, Tasmania, 7000, Australia
Qe Ii Hsc /Id# 133408
Halifax, Nova Scotia, B3H 1V7, Canada
Victoria Hospital /ID# 132161
London, Ontario, N6A 4L6, Canada
Windsor Regional Hospital /ID# 135989
Windsor, Ontario, N9C 3Z4, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155
Québec, Quebec, G6V 3Z1, Canada
Krajska nemocnice Liberec a.s. /ID# 132694
Liberec, 602 00, Czechia
Univ Hosp Ostrava-Poruba /ID# 132690
Ostrava, 708 52, Czechia
Multiscan s.r.o. /ID# 132689
Pardubice, 532 03, Czechia
Vseobecna Fakultni Nemocnice /ID# 135118
Prague, 128 08, Czechia
Odense Universitets Hospital /ID# 131912
Odense C, Region Syddanmark, 5000, Denmark
Satakunnan Sairaanhoitopiiri /ID# 133632
Pori, 28500, Finland
Vaasa Central Hospital /ID# 131930
Vaasa, 65130, Finland
Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927
Berlin, 12203, Germany
Lungen Clinic Grosshansdorf /ID# 131928
Großhansdorf, 22927, Germany
Univ Klinik Eppendorf Hamburg /ID# 131926
Hamburg, 20246, Germany
Klinik Loewenstein GmbH /ID# 131925
Löwenstein, 74245, Germany
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 132738
Budapest XII, Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 132742
Debrecen, 4032, Hungary
Koch Robert Hospital /ID# 133440
Edelény, 3780, Hungary
Veszprem Megyei Tudogyogyintez /ID# 132739
Farkasgyepű, 8582, Hungary
Petz Aladar Megyei Oktato Korh /ID# 132741
Győr, 9023, Hungary
Matrahaza Gyogyintezet /ID# 132743
Kékesteto, 3233, Hungary
Assaf Harofeh Medical Center /ID# 132830
Be’er Ya‘aqov, 70300, Israel
Shaare Zedek Medical Center /ID# 132834
Jerusalem, 91031, Israel
Meir Medical Center /ID# 132832
Kfar Saba, 4428164, Israel
Sheba Medical Center /ID# 132833
Ramat Gan, 5239424, Israel
Aichi Cancer Center Hospital /ID# 134129
Nagoya, Aichi-ken, 464-8681, Japan
Kurume University Hospital /ID# 134117
Kurume-shi, Fukuoka, 830-0011, Japan
Hokkaido University Hospital /ID# 134123
Sapporo, Hokkaido, 060-8648, Japan
Kanagawa Cardiovascular and Respiratory Center /ID# 134127
Yokohama, Kanagawa, 236-0051, Japan
Sendai Kousei Hospital /ID# 135491
Sendai, Miyagi, 980-0873, Japan
Osaka City General Hospital /ID# 134115
Osaka, Osaka, 534-0021, Japan
Kindai University Hospital /ID# 134112
Osaka-sayama-shi, Osaka, 589-8511, Japan
National Cancer Center Hospital /ID# 135129
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 135492
Koto-ku, Tokyo, 135-8550, Japan
Yamaguchi - Ube Medical Center /ID# 135284
Ube-shi, Yamaguchi, 755-0241, Japan
Hiroshima Citizens Hospital /ID# 135130
Hiroshima, 730-8518, Japan
Kishiwada City Hospital /ID# 136548
Kishiwada, 596-8501, Japan
Jeroen Bosch Ziekenhuis /ID# 131968
's-Hertogenbosch, 5223 GZ, Netherlands
Vrije Universiteit Medisch Centrum /ID# 131967
Amsterdam, 1081 HV, Netherlands
Catharina Ziekenhuis /ID# 131966
Eindhoven, 5623 EJ, Netherlands
Ziekenhuis St. Jansdal /ID# 131965
Harderwijk, 3844 DG, Netherlands
St. Antonius Ziekenhuis /ID# 133635
Nieuwegein, 3435 CM, Netherlands
Canterbury District Health Boa /ID# 132469
Christchurch, 8011, New Zealand
Wellington Hospital (Capital and Coast District Health Board) /ID# 132470
Wellington, 6021, New Zealand
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085
Moscow, Moscow, 115478, Russia
Sverdlovsk Regional Oncology Center Dispensary /ID# 132375
Yekaterinburg, Sverdlovsk Oblast, 620043, Russia
archangel Clinical Oncology /ID# 132376
Arkhangelsk, 163045, Russia
Moscow Regional Onc Dispensary /ID# 132381
Balashikha, 143900, Russia
Belgorod Oncology Dispensary /ID# 142638
Belgorod, 308010, Russia
Moscow Res Onc Inst Hertsen /ID# 132370
Moscow, 125284, Russia
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087
Murmansk, 183047, Russia
Orenburg Regional Clinical Onc /ID# 132371
Orenburg, 460021, Russia
Strategic medical systems LLC /ID# 206383
Saint Petersburg, 192148, Russia
LLC BioEq Ltd. /ID# 132372
Saint Petersburg, 197342, Russia
N.N. Petrov Research Inst Onc /ID# 137084
Saint Petersburg, 197758, Russia
Ogarev Mordovia State Univ /ID# 132377
Saransk, 430005, Russia
GVI Oncology /ID# 133268
Port Elizabeth, Eastern Cape, 6006, South Africa
Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775
Pretoria, Gauteng, 0044, South Africa
Mary Potter Oncology Centre /ID# 131776
Pretoria, Gauteng, 0181, South Africa
The Oncology Centre /ID# 131773
Durban, KwaZulu-Natal, 4091, South Africa
Netcare Oncology Intervent Ctr /ID# 131777
Cape Town, Western Cape, 7460, South Africa
Cape Town Oncology Trials /ID# 132734
Cape Town, Western Cape, 7570, South Africa
GVI Rondebosch Oncology Centre /ID# 132732
Cape Town, Western Cape, 7700, South Africa
Sandton Oncology Medical Group /ID# 131774
Johannesburg, 2196, South Africa
Dong-A University Hospital /ID# 131609
Busan, Busan Gwang Yeogsi, 49201, South Korea
Seoul National Univ Bundang ho /ID# 131610
Seongnam, Gyeonggido, 13620, South Korea
Inha University Hospital /ID# 147924
Junggu, Incheon Gwang Yeogsi, 22332, South Korea
Chonnam National University Hospital /ID# 131612
Gwangju, Jeonranamdo, 61469, South Korea
Samsung Medical Center /ID# 132471
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Chungbuk National Univ Hosp /ID# 131611
Cheongju-si, 28644, South Korea
Hospital Duran i Reynals /ID# 132879
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Fundacion Alcorcon /ID# 132909
Alcorcón, 28922, Spain
Hospital General Universitario Alicante /ID# 132881
Alicante, 03010, Spain
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876
Barcelona, 08028, Spain
Hospital Universitario Vall d'Hebron /ID# 132871
Barcelona, 08035, Spain
MD Anderson Madrid /ID# 132905
Madrid, 28033, Spain
Hospital Universitario La Paz /ID# 132870
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro /ID# 132869
Madrid, 28050, Spain
Hospital Clinico Universitario de Valencia /ID# 132873
Valencia, 46010, Spain
China Medical University Hosp /ID# 131870
Taichung, Taichung, 40447, Taiwan
Dalin Tzu Chi General Hospital /ID# 131872
Dalin Township, 622, Taiwan
Taipei Medical University Hospital /ID# 133817
Taipei, 11031, Taiwan
Taipei Veterans General Hosp /ID# 131871
Taipei, 11217, Taiwan
Hacettepe University Medical Faculty /ID# 131913
Ankara, 06100, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 131914
Ankara, 06590, Turkey (Türkiye)
Uludag University Medical Faculty /ID# 131915
Bursa, 16059, Turkey (Türkiye)
Dicle Universitesi Tip /ID# 136570
Diyarbakır, 21200, Turkey (Türkiye)
Gaziantep Universitesi Med /ID# 131917
Gaziantep, 27310, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 136568
Izmir, 35110, Turkey (Türkiye)
Inonu University /ID# 136569
Malatya, 44280, Turkey (Türkiye)
Leicester Royal Infirmary /ID# 133930
Leicester, England, LE1 5WW, United Kingdom
Cheltenham General Hospital /ID# 131951
Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 131953
Norwich, Norfolk, NR4 7UY, United Kingdom
Royal United Hospitals Bath /ID# 132851
Bath, BA1 3NG, United Kingdom
Belfast City Hospital /ID# 132858
Belfast, BT9 7AB, United Kingdom
Heart of England NHS Foundation Trust /ID# 132855
Birmingham, B9 5SS, United Kingdom
Royal Blackburn Hospital /ID# 132853
Blackburn, BB2 3HH, United Kingdom
Colchester General Hospital /ID# 133929
Colchester, CO4 5JL, United Kingdom
Castle Hill Hospital /ID# 135489
Cottingham, HU16 5JQ, United Kingdom
Scunthorpe General Hospital /ID# 133931
Doncaster, DN15 7BH, United Kingdom
James Paget University Hosp /ID# 131954
Great Yarmouth, NR31 6LA, United Kingdom
Royal Gwent Hospital /ID# 133935
Gwent, NP20 2UB, United Kingdom
Huddersfield Royal Infirmary /ID# 132854
Huddersfield, HD3 3EA, United Kingdom
Charing Cross Hospital /ID# 131959
London, W6 8RF, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661
Newcastle upon Tyne, NE7 7DN, United Kingdom
York Hospital /ID# 132859
York, YO31 8HE, United Kingdom
Related Publications (1)
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.
PMID: 35331641DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
October 15, 2014
Study Start
September 30, 2014
Primary Completion
November 14, 2019
Study Completion
February 21, 2020
Last Updated
February 26, 2021
Results First Posted
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.