AzTrials
AzTrials

Non-squamous Non-small Cell Lung CancerPhase 3NCT02264990

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 Phase 3 study testing Paclitaxel, Carboplatin and Cisplatin in people with Non-squamous Non-small Cell Lung Cancer, run by AbbVie at 140 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-squamous Non-small Cell Lung Cancer
What is being tested?
Paclitaxel, Carboplatin and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
595 participants
Where
140 sitesin 20 countries
Study dates
30 Sep 2014to 21 Feb 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

140 sites in 20 countries.

140 sites in 20 countries

United States25 sites

  • CBCC Global Research, Inc. at /ID# 132709

    Bakersfield, California, 93309

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

    Camden, New Jersey, 08103

  • Gabrail Cancer Center Research /ID# 130205

    Canton, Ohio, 44718

  • UT Southwestern Medical Center /ID# 130236

    Dallas, Texas, 75390-7208

  • Henry Ford Health System /ID# 130234

    Detroit, Michigan, 48202

  • California Cancer Assoc. R&E /ID# 131392

    Encinitas, California, 92024

  • California Cancer Assoc. R&E /ID# 131949

    Encinitas, California, 92024

  • NorthShore University HealthSystem - Evanston Hospital /ID# 130200

    Evanston, Illinois, 60201

  • University of Florida - Archer /ID# 132408

    Gainesville, Florida, 32610

  • The Jones Clinic, PC /ID# 130215

    Germantown, Tennessee, 38138

  • Goshen Center for Cancer Care /ID# 130216

    Goshen, Indiana, 46526

  • Clearview Cancer Institute /ID# 131434

    Huntsville, Alabama, 35805

  • Cancer Center of Acadiana /ID# 133611

    Lafayette, Louisiana, 70503

  • Herbert Herman Cancer Center /ID# 130239

    Lansing, Michigan, 48912

  • LA Hem-Oncology Med Group /ID# 131639

    Los Angeles, California, 90017

  • University of Louisville /ID# 130217

    Louisville, Kentucky, 40202

  • University of South Alabama /ID# 131518

    Mobile, Alabama, 36617

  • Univ Oklahoma HSC /ID# 132888

    Oklahoma City, Oklahoma, 73104

  • Albert Einstein Medical Center /ID# 134498

    Philadelphia, Pennsylvania, 19141

  • Allegheny General Hospital /ID# 134049

    Pittsburgh, Pennsylvania, 15212

  • Univ Texas HSC San Antonio /ID# 132972

    San Antonio, Texas, 78229

  • St Jude Hospital dba St Joseph /ID# 132943

    Santa Rosa, California, 95403

  • Highlands Oncology Group /ID# 131250

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 131651

    St Louis, Missouri, 63110

  • Icri /Id# 132942

    Whittier, California, 90603

Other trials in United States

United Kingdom16 sites

  • Royal United Hospitals Bath /ID# 132851

    Bath, BA1 3NG

  • Belfast City Hospital /ID# 132858

    Belfast, BT9 7AB

  • Heart of England NHS Foundation Trust /ID# 132855

    Birmingham, B9 5SS

  • Royal Blackburn Hospital /ID# 132853

    Blackburn, BB2 3HH

  • Cheltenham General Hospital /ID# 131951

    Cheltenham, Gloucestershire, GL53 7AN

  • Colchester General Hospital /ID# 133929

    Colchester, CO4 5JL

  • Castle Hill Hospital /ID# 135489

    Cottingham, HU16 5JQ

  • Scunthorpe General Hospital /ID# 133931

    Doncaster, DN15 7BH

  • James Paget University Hosp /ID# 131954

    Great Yarmouth, NR31 6LA

  • Royal Gwent Hospital /ID# 133935

    Gwent, NP20 2UB

  • Huddersfield Royal Infirmary /ID# 132854

    Huddersfield, HD3 3EA

  • Leicester Royal Infirmary /ID# 133930

    Leicester, England, LE1 5WW

  • Charing Cross Hospital /ID# 131959

    London, W6 8RF

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

    Newcastle upon Tyne, NE7 7DN

  • Norfolk and Norwich Univ Hosp /ID# 131953

    Norwich, Norfolk, NR4 7UY

  • York Hospital /ID# 132859

    York, YO31 8HE

Other trials in United Kingdom

Japan12 sites

  • National Cancer Center Hospital /ID# 135129

    Chuo-ku, Tokyo, 104-0045

  • Hiroshima Citizens Hospital /ID# 135130

    Hiroshima, 730-8518

  • Kishiwada City Hospital /ID# 136548

    Kishiwada, 596-8501

  • The Cancer Institute Hospital Of JFCR /ID# 135492

    Koto-ku, Tokyo, 135-8550

  • Kurume University Hospital /ID# 134117

    Kurume-shi, Fukuoka, 830-0011

  • Aichi Cancer Center Hospital /ID# 134129

    Nagoya, Aichi-ken, 464-8681

  • Osaka City General Hospital /ID# 134115

    Osaka, Osaka, 534-0021

  • Kindai University Hospital /ID# 134112

    Osaka-sayama-shi, Osaka, 589-8511

  • Hokkaido University Hospital /ID# 134123

    Sapporo, Hokkaido, 060-8648

  • Sendai Kousei Hospital /ID# 135491

    Sendai, Miyagi, 980-0873

  • Yamaguchi - Ube Medical Center /ID# 135284

    Ube-shi, Yamaguchi, 755-0241

  • Kanagawa Cardiovascular and Respiratory Center /ID# 134127

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

Russia12 sites

  • archangel Clinical Oncology /ID# 132376

    Arkhangelsk, 163045

  • Moscow Regional Onc Dispensary /ID# 132381

    Balashikha, 143900

  • Belgorod Oncology Dispensary /ID# 142638

    Belgorod, 308010

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

    Moscow, Moscow, 115478

  • Moscow Res Onc Inst Hertsen /ID# 132370

    Moscow, 125284

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

    Murmansk, 183047

  • Orenburg Regional Clinical Onc /ID# 132371

    Orenburg, 460021

  • Strategic medical systems LLC /ID# 206383

    Saint Petersburg, 192148

  • LLC BioEq Ltd. /ID# 132372

    Saint Petersburg, 197342

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

    Saint Petersburg, 197758

  • Ogarev Mordovia State Univ /ID# 132377

    Saransk, 430005

  • Sverdlovsk Regional Oncology Center Dispensary /ID# 132375

    Yekaterinburg, Sverdlovsk Oblast, 620043

Other trials in Russia

Spain9 sites

  • Hospital Universitario Fundacion Alcorcon /ID# 132909

    Alcorcón, 28922

  • Hospital General Universitario Alicante /ID# 132881

    Alicante, 03010

  • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876

    Barcelona, 08028

  • Hospital Universitario Vall d'Hebron /ID# 132871

    Barcelona, 08035

  • Hospital Duran i Reynals /ID# 132879

    L'Hospitalet de Llobregat, Barcelona, 08907

  • MD Anderson Madrid /ID# 132905

    Madrid, 28033

  • Hospital Universitario La Paz /ID# 132870

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro /ID# 132869

    Madrid, 28050

  • Hospital Clinico Universitario de Valencia /ID# 132873

    Valencia, 46010

Other trials in Spain

South Africa8 sites

  • Netcare Oncology Intervent Ctr /ID# 131777

    Cape Town, Western Cape, 7460

  • Cape Town Oncology Trials /ID# 132734

    Cape Town, Western Cape, 7570

  • GVI Rondebosch Oncology Centre /ID# 132732

    Cape Town, Western Cape, 7700

  • The Oncology Centre /ID# 131773

    Durban, KwaZulu-Natal, 4091

  • Sandton Oncology Medical Group /ID# 131774

    Johannesburg, 2196

  • GVI Oncology /ID# 133268

    Port Elizabeth, Eastern Cape, 6006

  • Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775

    Pretoria, Gauteng, 0044

  • Mary Potter Oncology Centre /ID# 131776

    Pretoria, Gauteng, 0181

Other trials in South Africa

Hungary7 sites

  • Orszagos Koranyi Pulmonologiai Intezet /ID# 132738

    Budapest XII, Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont /ID# 132742

    Debrecen, 4032

  • Koch Robert Hospital /ID# 133440

    Edelény, 3780

  • Veszprem Megyei Tudogyogyintez /ID# 132739

    Farkasgyepű, 8582

  • Petz Aladar Megyei Oktato Korh /ID# 132741

    Győr, 9023

  • Matrahaza Gyogyintezet /ID# 132743

    Kékesteto, 3233

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441

    Miskolc, Borsod-Abauj Zemplen county, 3529

Other trials in Hungary

Turkey (Türkiye)7 sites

  • Hacettepe University Medical Faculty /ID# 131913

    Ankara, 06100

  • Ankara Univ Medical Faculty /ID# 131914

    Ankara, 06590

  • Uludag University Medical Faculty /ID# 131915

    Bursa, 16059

  • Dicle Universitesi Tip /ID# 136570

    Diyarbakır, 21200

  • Gaziantep Universitesi Med /ID# 131917

    Gaziantep, 27310

  • Dr. Suat Seren Gogus Has /ID# 136568

    Izmir, 35110

  • Inonu University /ID# 136569

    Malatya, 44280

Other trials in Turkey (Türkiye)

South Korea6 sites

  • Dong-A University Hospital /ID# 131609

    Busan, Busan Gwang Yeogsi, 49201

  • Chungbuk National Univ Hosp /ID# 131611

    Cheongju-si, 28644

  • Chonnam National University Hospital /ID# 131612

    Gwangju, Jeonranamdo, 61469

  • Inha University Hospital /ID# 147924

    Junggu, Incheon Gwang Yeogsi, 22332

  • Seoul National Univ Bundang ho /ID# 131610

    Seongnam, Gyeonggido, 13620

  • Samsung Medical Center /ID# 132471

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Netherlands5 sites

  • Jeroen Bosch Ziekenhuis /ID# 131968

    's-Hertogenbosch, 5223 GZ

  • Vrije Universiteit Medisch Centrum /ID# 131967

    Amsterdam, 1081 HV

  • Catharina Ziekenhuis /ID# 131966

    Eindhoven, 5623 EJ

  • Ziekenhuis St. Jansdal /ID# 131965

    Harderwijk, 3844 DG

  • St. Antonius Ziekenhuis /ID# 133635

    Nieuwegein, 3435 CM

Other trials in Netherlands

Argentina4 sites

  • Coiba /Id# 132153

    Berazategui, Buenos Aires, 1884

  • Centro Investigacion Pergamino /ID# 132152

    Pergamino, 2700

  • Hospital Britanico /ID# 134874

    Rosario, Santa FE, 2000

  • Instituto de Oncologia de Rosa /ID# 132150

    Rosario, Santa FE, 2000

Other trials in Argentina

Australia4 sites

  • Flinders Centre for Innovation /ID# 134288

    Bedford Park, South Australia, 5042

  • Royal Hobart Hospital /ID# 132477

    Hobart, Tasmania, 7000

  • St George Hospital /ID# 132481

    Kogarah, New South Wales, 2217

  • Southern Medical Day Care Ctr /ID# 132482

    Wollongong, New South Wales, 2500

Other trials in Australia

Canada4 sites

  • Qe Ii Hsc /Id# 133408

    Halifax, Nova Scotia, B3H 1V7

  • Victoria Hospital /ID# 132161

    London, Ontario, N6A 4L6

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

    Québec, Quebec, G6V 3Z1

  • Windsor Regional Hospital /ID# 135989

    Windsor, Ontario, N9C 3Z4

Other trials in Canada

Czechia4 sites

  • Krajska nemocnice Liberec a.s. /ID# 132694

    Liberec, 602 00

  • Univ Hosp Ostrava-Poruba /ID# 132690

    Ostrava, 708 52

  • Multiscan s.r.o. /ID# 132689

    Pardubice, 532 03

  • Vseobecna Fakultni Nemocnice /ID# 135118

    Prague, 128 08

Other trials in Czechia

Germany4 sites

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

    Berlin, 12203

  • Lungen Clinic Grosshansdorf /ID# 131928

    Großhansdorf, 22927

  • Univ Klinik Eppendorf Hamburg /ID# 131926

    Hamburg, 20246

  • Klinik Loewenstein GmbH /ID# 131925

    Löwenstein, 74245

Other trials in Germany

Israel4 sites

  • Assaf Harofeh Medical Center /ID# 132830

    Be’er Ya‘aqov, 70300

  • Shaare Zedek Medical Center /ID# 132834

    Jerusalem, 91031

  • Meir Medical Center /ID# 132832

    Kfar Saba, 4428164

  • Sheba Medical Center /ID# 132833

    Ramat Gan, 5239424

Other trials in Israel

Taiwan4 sites

  • Dalin Tzu Chi General Hospital /ID# 131872

    Dalin Township, 622

  • China Medical University Hosp /ID# 131870

    Taichung, Taichung, 40447

  • Taipei Medical University Hospital /ID# 133817

    Taipei, 11031

  • Taipei Veterans General Hosp /ID# 131871

    Taipei, 11217

Other trials in Taiwan

Finland2 sites

  • Satakunnan Sairaanhoitopiiri /ID# 133632

    Pori, 28500

  • Vaasa Central Hospital /ID# 131930

    Vaasa, 65130

Other trials in Finland

New Zealand2 sites

  • Canterbury District Health Boa /ID# 132469

    Christchurch, 8011

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

    Wellington, 6021

Other trials in New Zealand

Denmark1 site

  • Odense Universitets Hospital /ID# 131912

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

About this study

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

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.

Being tested
Paclitaxel, Carboplatin, Cisplatin, Veliparib, Pemetrexed
Keywords
veliparib, carboplatin, paclitaxel, cisplatin, pemetrexed, Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP), Metastatic, Non-squamous, Non-small cell lung cancer
Medical subject headings
Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

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

  • CarboplatinDrug

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

  • CisplatinDrug

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

  • VeliparibDrug

    Also called ABT-888

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

  • PemetrexedDrug

    Also called Alimta

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

Study groups in NCT02264990
Study groupRoleWhat they receive
Veliparib + Carboplatin + PaclitaxelExperimentalParticipants 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.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Veliparib; Drug: Pemetrexed
Investigator's Choice ChemotherapyActive 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.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study start30 Sep 2014
  3. Primary completion14 Nov 2019
  4. Study completion21 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264990
Sponsor's protocol ID
M14-359
Other IDs
2014-002565-30, 2014
Status last verified
Feb 2021
First submitted
9 Oct 2014
Last updated
26 Feb 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35331641

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, Carboplatin and Cisplatin in people with Non-squamous Non-small Cell Lung Cancer, run by AbbVie at 140 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, United Kingdom, Japan, Russia, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02264990, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.

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