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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02264990
Other study ID # M14-359
Secondary ID 2014-002565-30
Status Completed
Phase Phase 3
First received
Last updated
Start date September 30, 2014
Est. completion date February 21, 2020

Study information

Verified date February 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 595
Est. completion date February 21, 2020
Est. primary completion date November 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Cisplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Veliparib
Oral capsule, administered twice daily for 7 days in each 21-day cycle
Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Czechia,  Denmark,  Finland,  Germany,  Hungary,  Israel,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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.
Secondary 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.
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.
Secondary 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. 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.
Secondary 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.
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.
Secondary 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.
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.
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