Clinical trial NCT02264990: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
timeFrame: 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:
measure: Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
timeFrame: 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.
measure: Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
timeFrame: 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.
measure: Overall Survival in All Participants
timeFrame: 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.
measure: Progression Free Survival (PFS) in All Participants
timeFrame: 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.
measure: Objective Response Rate (ORR) in All Participants
timeFrame: 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.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute /ID# 131434
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama /ID# 131518
state: Alabama
city: Springdale
country: United States
facility: Highlands Oncology Group /ID# 131250
state: Arkansas
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at /ID# 132709
state: California
city: Encinitas
country: United States
facility: California Cancer Assoc. R&E /ID# 131392
state: California
city: Encinitas
country: United States
facility: California Cancer Assoc. R&E /ID# 131949
state: California
city: Los Angeles
country: United States
facility: LA Hem-Oncology Med Group /ID# 131639
state: California
city: Santa Rosa
country: United States
facility: St Jude Hospital dba St Joseph /ID# 132943
state: California
city: Whittier
country: United States
facility: Icri /Id# 132942
state: California
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 132408
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital /ID# 130200
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care /ID# 130216
state: Indiana
city: Louisville
country: United States
facility: University of Louisville /ID# 130217
state: Kentucky
city: Lafayette
country: United States
facility: Cancer Center of Acadiana /ID# 133611
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 130234
state: Michigan
city: Lansing
country: United States
facility: Herbert Herman Cancer Center /ID# 130239
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 131651
state: Missouri
city: Camden
country: United States
facility: MD Anderson Cancer Center at Cooper - Camden /ID# 131490
state: New Jersey
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 130205
state: Ohio
city: Oklahoma City
country: United States
facility: Univ Oklahoma HSC /ID# 132888
state: Oklahoma
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center /ID# 134498
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital /ID# 134049
state: Pennsylvania
city: Germantown
country: United States
facility: The Jones Clinic, PC /ID# 130215
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center /ID# 130236
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 132972
state: Texas
city: Berazategui, Buenos Aires
country: Argentina
facility: Coiba /Id# 132153
city: Pergamino
country: Argentina
facility: Centro Investigacion Pergamino /ID# 132152
city: Rosario, Santa FE
country: Argentina
facility: Hospital Britanico /ID# 134874
city: Rosario, Santa FE
country: Argentina
facility: Instituto de Oncologia de Rosa /ID# 132150
city: Kogarah
country: Australia
facility: St George Hospital /ID# 132481
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Ctr /ID# 132482
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Centre for Innovation /ID# 134288
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital /ID# 132477
state: Tasmania
city: Halifax
country: Canada
facility: Qe Ii Hsc /Id# 133408
state: Nova Scotia
city: London
country: Canada
facility: Victoria Hospital /ID# 132161
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital /ID# 135989
state: Ontario
city: Quebec City
country: Canada
facility: CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155
state: Quebec
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec a.s. /ID# 132694
city: Ostrava
country: Czechia
facility: Univ Hosp Ostrava-Poruba /ID# 132690
city: Pardubice
country: Czechia
facility: Multiscan s.r.o. /ID# 132689
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice /ID# 135118
city: Odense C
country: Denmark
facility: Odense Universitets Hospital /ID# 131912
state: Syddanmark
city: Pori
country: Finland
facility: Satakunnan Sairaanhoitopiiri /ID# 133632
city: Vaasa
country: Finland
facility: Vaasa Central Hospital /ID# 131930
city: Berlin
country: Germany
facility: Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927
city: Grosshansdorf
country: Germany
facility: Lungen Clinic Grosshansdorf /ID# 131928
city: Hamburg
country: Germany
facility: Univ Klinik Eppendorf Hamburg /ID# 131926
city: Löwenstein
country: Germany
facility: Klinik Loewenstein GmbH /ID# 131925
city: Miskolc
country: Hungary
facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441
state: Borsod-Abauj-Zemplen
city: Budapest XII
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 132738
state: Budapest
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 132742
city: Edelény
country: Hungary
facility: Koch Robert Hospital /ID# 133440
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintez /ID# 132739
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korh /ID# 132741
city: Kékesteto
country: Hungary
facility: Matrahaza Gyogyintezet /ID# 132743
city: Be'er Ya'akov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 132830
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 132834
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 132832
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 132833
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 134129
state: Aichi
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 134117
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 134123
state: Hokkaido
city: Yokohama-shi
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center /ID# 134127
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital /ID# 135491
state: Miyagi
city: Osaka-sayama-shi
country: Japan
facility: Kindai University Hospital /ID# 134112
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 134115
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 135129
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 135492
state: Tokyo
city: Ube-shi
country: Japan
facility: Yamaguchi - Ube Medical Center /ID# 135284
state: Yamaguchi
city: Hiroshima
country: Japan
facility: Hiroshima Citizens Hospital /ID# 135130
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital /ID# 136548
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital /ID# 131609
state: Busan Gwang Yeogsi
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ Bundang ho /ID# 131610
state: Gyeonggido
city: Jung-gu
country: Korea, Republic of
facility: Inha University Hospital /ID# 147924
state: Incheon Gwang Yeogsi
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 131612
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 132471
state: Seoul Teugbyeolsi
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National Univ Hosp /ID# 131611
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum /ID# 131967
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis /ID# 131966
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal /ID# 131965
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 133635
city: S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis /ID# 131968
city: Christchurch
country: New Zealand
facility: Canterbury District Health Boa /ID# 132469
city: Wellington
country: New Zealand
facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 132470
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085
state: Moskva
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Center Dispensary /ID# 132375
state: Sverdlovskaya Oblast
city: Arkhangelsk
country: Russian Federation
facility: archangel Clinical Oncology /ID# 132376
city: Balashikha
country: Russian Federation
facility: Moscow Regional Onc Dispensary /ID# 132381
city: Belgorod
country: Russian Federation
facility: Belgorod Oncology Dispensary /ID# 142638
city: Moscow
country: Russian Federation
facility: Moscow Res Onc Inst Hertsen /ID# 132370
city: Murmansk
country: Russian Federation
facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Onc /ID# 132371
city: Sankt-Peterburg
country: Russian Federation
facility: Strategic medical systems LLC /ID# 206383
city: Saransk
country: Russian Federation
facility: Ogarev Mordovia State Univ /ID# 132377
city: St. Petersburg
country: Russian Federation
facility: LLC BioEq Ltd. /ID# 132372
city: St. Petersburg
country: Russian Federation
facility: N.N. Petrov Research Inst Onc /ID# 137084
city: Port Elizabeth
country: South Africa
facility: GVI Oncology /ID# 133268
state: Eastern Cape
city: Pretoria
country: South Africa
facility: Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre /ID# 131776
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre /ID# 131773
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Netcare Oncology Intervent Ctr /ID# 131777
state: Western Cape
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials /ID# 132734
state: Western Cape
city: Cape Town
country: South Africa
facility: GVI Rondebosch Oncology Centre /ID# 132732
state: Western Cape
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group /ID# 131774
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals /ID# 132879
state: Barcelona
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon /ID# 132909
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante /ID# 132881
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 132871
city: Madrid
country: Spain
facility: MD Anderson Madrid /ID# 132905
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 132870
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 132869
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 132873
city: Taichung City
country: Taiwan
facility: China Medical University Hosp /ID# 131870
state: Taichung
city: Dalin Township
country: Taiwan
facility: Dalin Tzu Chi General Hospital /ID# 131872
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital /ID# 133817
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 131871
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty /ID# 131913
city: Ankara
country: Turkey
facility: Ankara Univ Medical Faculty /ID# 131914
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty /ID# 131915
city: Diyarbakir
country: Turkey
facility: Dicle Universitesi Tip /ID# 136570
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Med /ID# 131917
city: Izmir
country: Turkey
facility: Dr. Suat Seren Gogus Has /ID# 136568
city: Malatya
country: Turkey
facility: Inonu University /ID# 136569
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary /ID# 133930
state: England
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital /ID# 131951
state: Gloucestershire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Univ Hosp /ID# 131953
state: Norfolk
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath /ID# 132851
city: Belfast
country: United Kingdom
facility: Belfast City Hospital /ID# 132858
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust /ID# 132855
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital /ID# 132853
city: Colchester
country: United Kingdom
facility: Colchester General Hospital /ID# 133929
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital /ID# 135489
city: Doncaster
country: United Kingdom
facility: Scunthorpe General Hospital /ID# 133931
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hosp /ID# 131954
city: Gwent
country: United Kingdom
facility: Royal Gwent Hospital /ID# 133935
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary /ID# 132854
city: London
country: United Kingdom
facility: Charing Cross Hospital /ID# 131959
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661
city: York
country: United Kingdom
facility: York Hospital /ID# 132859
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.