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

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.

Study Overview

• Status: Completed
• Conditions: Non-squamous Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Carboplatin; Drug: Veliparib; Drug: Pemetrexed; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 595
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Berazategui, Buenos Aires, Argentina, 1884
    • Coiba /Id# 132153
  • Pergamino, Argentina, 2700
    • Centro Investigacion Pergamino /ID# 132152
  • Rosario, Santa FE, Argentina, 2000
    • Hospital Britanico /ID# 134874
  • Rosario, Santa FE, Argentina, 2000
    • Instituto de Oncologia de Rosa /ID# 132150
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital /ID# 132481
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Ctr /ID# 132482
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Centre for Innovation /ID# 134288
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital /ID# 132477
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Qe Ii Hsc /Id# 133408
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Victoria Hospital /ID# 132161
    • Windsor, Ontario, Canada, N9C 3Z4
      • Windsor Regional Hospital /ID# 135989
  • Quebec
    • Quebec City, Quebec, Canada, G6V 3Z1
      • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155
• Czechia
  • Liberec, Czechia, 602 00
    • Krajska nemocnice Liberec a.s. /ID# 132694
  • Ostrava, Czechia, 708 52
    • Univ Hosp Ostrava-Poruba /ID# 132690
  • Pardubice, Czechia, 532 03
    • Multiscan s.r.o. /ID# 132689
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice /ID# 135118
• Denmark
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense Universitets Hospital /ID# 131912
• Finland
  • Pori, Finland, 28500
    • Satakunnan Sairaanhoitopiiri /ID# 133632
  • Vaasa, Finland, 65130
    • Vaasa Central Hospital /ID# 131930
• Germany
  • Berlin, Germany, 12203
    • Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927
  • Grosshansdorf, Germany, 22927
    • Lungen Clinic Grosshansdorf /ID# 131928
  • Hamburg, Germany, 20246
    • Univ Klinik Eppendorf Hamburg /ID# 131926
  • Löwenstein, Germany, 74245
    • Klinik Loewenstein GmbH /ID# 131925
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont /ID# 132742
  • Edelény, Hungary, 3780
    • Koch Robert Hospital /ID# 133440
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Tudogyogyintez /ID# 132739
  • Gyor, Hungary, 9023
    • Petz Aladar Megyei Oktato Korh /ID# 132741
  • Kékesteto, Hungary, 3233
    • Matrahaza Gyogyintezet /ID# 132743
  • Borsod-Abauj-Zemplen
    • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
      • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441
  • Budapest
    • Budapest XII, Budapest, Hungary, 1122
      • Orszagos Koranyi Pulmonologiai Intezet /ID# 132738
• Israel
  • Be'er Ya'akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 132830
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 132834
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 132832
  • Ramat Gan, Israel, 5239424
    • Sheba Medical Center /ID# 132833
• Japan
  • Hiroshima, Japan, 730-8518
    • Hiroshima Citizens Hospital /ID# 135130
  • Kishiwada, Japan, 596-8501
    • Kishiwada City Hospital /ID# 136548
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 134129
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 134117
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 134123
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 236-0051
      • Kanagawa Cardiovascular and Respiratory Center /ID# 134127
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital /ID# 135491
  • Osaka
    • Osaka-sayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 134112
    • Osaka-shi, Osaka, Japan, 534-0021
      • Osaka City General Hospital /ID# 134115
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 135129
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 135492
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 755-0241
      • Yamaguchi - Ube Medical Center /ID# 135284
• Korea, Republic of
  • Cheongju, Korea, Republic of, 28644
    • Chungbuk National Univ Hosp /ID# 131611
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
      • Dong-A University Hospital /ID# 131609
  • Gyeonggido
    • Seongnam, Gyeonggido, Korea, Republic of, 13620
      • Seoul National Univ Bundang ho /ID# 131610
  • Incheon Gwang Yeogsi
    • Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
      • Inha University Hospital /ID# 147924
  • Jeonranamdo
    • Gwangju, Jeonranamdo, Korea, Republic of, 61469
      • Chonnam National University Hospital /ID# 131612
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 132471
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Vrije Universiteit Medisch Centrum /ID# 131967
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis /ID# 131966
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St. Jansdal /ID# 131965
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis /ID# 133635
  • S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis /ID# 131968
• New Zealand
  • Christchurch, New Zealand, 8011
    • Canterbury District Health Boa /ID# 132469
  • Wellington, New Zealand, 6021
    • Wellington Hospital (Capital and Coast District Health Board) /ID# 132470
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • archangel Clinical Oncology /ID# 132376
  • Balashikha, Russian Federation, 143900
    • Moscow Regional Onc Dispensary /ID# 132381
  • Belgorod, Russian Federation, 308010
    • Belgorod Oncology Dispensary /ID# 142638
  • Moscow, Russian Federation, 125284
    • Moscow Res Onc Inst Hertsen /ID# 132370
  • Murmansk, Russian Federation, 183047
    • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087
  • Orenburg, Russian Federation, 460021
    • Orenburg Regional Clinical Onc /ID# 132371
  • Sankt-Peterburg, Russian Federation, 192148
    • Strategic medical systems LLC /ID# 206383
  • Saransk, Russian Federation, 430005
    • Ogarev Mordovia State Univ /ID# 132377
  • St. Petersburg, Russian Federation, 197342
    • LLC BioEq Ltd. /ID# 132372
  • St. Petersburg, Russian Federation, 197758
    • N.N. Petrov Research Inst Onc /ID# 137084
  • Moskva
    • Moscow, Moskva, Russian Federation, 115478
      • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085
  • Sverdlovskaya Oblast
    • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
      • Sverdlovsk Regional Oncology Center Dispensary /ID# 132375
• South Africa
  • Johannesburg, South Africa, 2196
    • Sandton Oncology Medical Group /ID# 131774
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6006
      • GVI Oncology /ID# 133268
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0044
      • Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre /ID# 131776
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre /ID# 131773
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7460
      • Netcare Oncology Intervent Ctr /ID# 131777
    • Cape Town, Western Cape, South Africa, 7570
      • Cape Town Oncology Trials /ID# 132734
    • Cape Town, Western Cape, South Africa, 7700
      • GVI Rondebosch Oncology Centre /ID# 132732
• Spain
  • Alcorcon, Spain, 28922
    • Hospital Universitario Fundacion Alcorcon /ID# 132909
  • Alicante, Spain, 03010
    • Hospital General Universitario Alicante /ID# 132881
  • Barcelona, Spain, 08028
    • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 132871
  • Madrid, Spain, 28033
    • MD Anderson Madrid /ID# 132905
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 132870
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 132869
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 132873
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Duran i Reynals /ID# 132879
• Taiwan
  • Dalin Township, Taiwan, 622
    • Dalin Tzu Chi General Hospital /ID# 131872
  • Taipei City, Taiwan, 11031
    • Taipei Medical University Hospital /ID# 133817
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 131871
  • Taichung
    • Taichung City, Taichung, Taiwan, 40447
      • China Medical University Hosp /ID# 131870
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty /ID# 131913
  • Ankara, Turkey, 06590
    • Ankara Univ Medical Faculty /ID# 131914
  • Bursa, Turkey, 16059
    • Uludag University Medical Faculty /ID# 131915
  • Diyarbakir, Turkey, 21200
    • Dicle Universitesi Tip /ID# 136570
  • Gaziantep, Turkey, 27310
    • Gaziantep Universitesi Med /ID# 131917
  • Izmir, Turkey, 35110
    • Dr. Suat Seren Gogus Has /ID# 136568
  • Malatya, Turkey, 44280
    • Inonu University /ID# 136569
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospitals Bath /ID# 132851
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital /ID# 132858
  • Birmingham, United Kingdom, B9 5SS
    • Heart of England NHS Foundation Trust /ID# 132855
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital /ID# 132853
  • Colchester, United Kingdom, CO4 5JL
    • Colchester General Hospital /ID# 133929
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital /ID# 135489
  • Doncaster, United Kingdom, DN15 7BH
    • Scunthorpe General Hospital /ID# 133931
  • Great Yarmouth, United Kingdom, NR31 6LA
    • James Paget University Hosp /ID# 131954
  • Gwent, United Kingdom, NP20 2UB
    • Royal Gwent Hospital /ID# 133935
  • Huddersfield, United Kingdom, HD3 3EA
    • Huddersfield Royal Infirmary /ID# 132854
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital /ID# 131959
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661
  • York, United Kingdom, YO31 8HE
    • York Hospital /ID# 132859
  • England
    • Leicester, England, United Kingdom, LE1 5WW
      • Leicester Royal Infirmary /ID# 133930
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
      • Cheltenham General Hospital /ID# 131951
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich Univ Hosp /ID# 131953
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Clearview Cancer Institute /ID# 131434
    • Mobile, Alabama, United States, 36617
      • University of South Alabama /ID# 131518
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group /ID# 131250
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc. at /ID# 132709
    • Encinitas, California, United States, 92024
      • California Cancer Assoc. R&E /ID# 131392
    • Encinitas, California, United States, 92024
      • California Cancer Assoc. R&E /ID# 131949
    • Los Angeles, California, United States, 90017
      • LA Hem-Oncology Med Group /ID# 131639
    • Santa Rosa, California, United States, 95403
      • St Jude Hospital dba St Joseph /ID# 132943
    • Whittier, California, United States, 90603
      • Icri /Id# 132942
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Archer /ID# 132408
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem - Evanston Hospital /ID# 130200
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 130216
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 130217
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Cancer Center of Acadiana /ID# 133611
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 130234
    • Lansing, Michigan, United States, 48912
      • Herbert Herman Cancer Center /ID# 130239
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 131651
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • MD Anderson Cancer Center at Cooper - Camden /ID# 131490
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 130205
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Univ Oklahoma HSC /ID# 132888
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center /ID# 134498
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital /ID# 134049
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Jones Clinic, PC /ID# 130215
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • UT Southwestern Medical Center /ID# 130236
    • San Antonio, Texas, United States, 78229
      • Univ Texas HSC San Antonio /ID# 132972

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veliparib + Carboplatin + Paclitaxel; 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.	Drug: Paclitaxel; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Drug: Carboplatin; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Drug: Veliparib; Oral capsule, administered twice daily for 7 days in each 21-day cycle; Other Names: ABT-888; Drug: Pemetrexed; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Other Names: Alimta
Active Comparator: Investigator's Choice Chemotherapy; 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.	Drug: Paclitaxel; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Drug: Carboplatin; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Drug: Pemetrexed; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Other Names: Alimta; Drug: Cisplatin; Administered by Intravenous infusion on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2014
• Primary Completion (Actual): November 14, 2019
• Study Completion (Actual): February 21, 2020

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cisplatin; veliparib; paclitaxel; carboplatin; Non-small cell lung cancer; Metastatic; pemetrexed; Non-squamous; Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Poly(ADP-ribose) Polymerase Inhibitors; Folic Acid Antagonists; Carboplatin; Paclitaxel; Veliparib; Pemetrexed
• Other Study ID Numbers: M14-359; 2014-002565-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No