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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

2021年2月8日 更新者：AbbVie

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

595

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Huntsville、Alabama、アメリカ、35805
        • Clearview Cancer Institute /ID# 131434
      • Mobile、Alabama、アメリカ、36617
        • University of South Alabama /ID# 131518
    • Arkansas
      • Springdale、Arkansas、アメリカ、72762
        • Highlands Oncology Group /ID# 131250
    • California
      • Bakersfield、California、アメリカ、93309
        • CBCC Global Research, Inc. at /ID# 132709
      • Encinitas、California、アメリカ、92024
        • California Cancer Assoc. R&E /ID# 131392
      • Encinitas、California、アメリカ、92024
        • California Cancer Assoc. R&E /ID# 131949
      • Los Angeles、California、アメリカ、90017
        • LA Hem-Oncology Med Group /ID# 131639
      • Santa Rosa、California、アメリカ、95403
        • St Jude Hospital dba St Joseph /ID# 132943
      • Whittier、California、アメリカ、90603
        • Icri /Id# 132942
    • Florida
      • Gainesville、Florida、アメリカ、32610
        • University of Florida - Archer /ID# 132408
    • Illinois
      • Evanston、Illinois、アメリカ、60201
        • NorthShore University HealthSystem - Evanston Hospital /ID# 130200
    • Indiana
      • Goshen、Indiana、アメリカ、46526
        • Goshen Center for Cancer Care /ID# 130216
    • Kentucky
      • Louisville、Kentucky、アメリカ、40202
        • University of Louisville /ID# 130217
    • Louisiana
      • Lafayette、Louisiana、アメリカ、70503
        • Cancer Center of Acadiana /ID# 133611
    • Michigan
      • Detroit、Michigan、アメリカ、48202
        • Henry Ford Health System /ID# 130234
      • Lansing、Michigan、アメリカ、48912
        • Herbert Herman Cancer Center /ID# 130239
    • Missouri
      • Saint Louis、Missouri、アメリカ、63110
        • Washington University-School of Medicine /ID# 131651
    • New Jersey
      • Camden、New Jersey、アメリカ、08103
        • MD Anderson Cancer Center at Cooper - Camden /ID# 131490
    • Ohio
      • Canton、Ohio、アメリカ、44718
        • Gabrail Cancer Center Research /ID# 130205
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73104
        • Univ Oklahoma HSC /ID# 132888
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19141
        • Albert Einstein Medical Center /ID# 134498
      • Pittsburgh、Pennsylvania、アメリカ、15212
        • Allegheny General Hospital /ID# 134049
    • Tennessee
      • Germantown、Tennessee、アメリカ、38138
        • The Jones Clinic, PC /ID# 130215
    • Texas
      • Dallas、Texas、アメリカ、75390-7208
        • UT Southwestern Medical Center /ID# 130236
      • San Antonio、Texas、アメリカ、78229
        • Univ Texas HSC San Antonio /ID# 132972
  • アルゼンチン
      • Berazategui, Buenos Aires、アルゼンチン、1884
        • Coiba /Id# 132153
      • Pergamino、アルゼンチン、2700
        • Centro Investigacion Pergamino /ID# 132152
      • Rosario, Santa FE、アルゼンチン、2000
        • Hospital Britanico /ID# 134874
      • Rosario, Santa FE、アルゼンチン、2000
        • Instituto de Oncologia de Rosa /ID# 132150
  • イギリス
      • Bath、イギリス、BA1 3NG
        • Royal United Hospitals Bath /ID# 132851
      • Belfast、イギリス、BT9 7AB
        • Belfast City Hospital /ID# 132858
      • Birmingham、イギリス、B9 5SS
        • Heart of England NHS Foundation Trust /ID# 132855
      • Blackburn、イギリス、BB2 3HH
        • Royal Blackburn Hospital /ID# 132853
      • Colchester、イギリス、CO4 5JL
        • Colchester General Hospital /ID# 133929
      • Cottingham、イギリス、HU16 5JQ
        • Castle Hill Hospital /ID# 135489
      • Doncaster、イギリス、DN15 7BH
        • Scunthorpe General Hospital /ID# 133931
      • Great Yarmouth、イギリス、NR31 6LA
        • James Paget University Hosp /ID# 131954
      • Gwent、イギリス、NP20 2UB
        • Royal Gwent Hospital /ID# 133935
      • Huddersfield、イギリス、HD3 3EA
        • Huddersfield Royal Infirmary /ID# 132854
      • London、イギリス、W6 8RF
        • Charing Cross Hospital /ID# 131959
      • Newcastle Upon Tyne、イギリス、NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661
      • York、イギリス、YO31 8HE
        • York Hospital /ID# 132859
    • England
      • Leicester、England、イギリス、LE1 5WW
        • Leicester Royal Infirmary /ID# 133930
    • Gloucestershire
      • Cheltenham、Gloucestershire、イギリス、GL53 7AN
        • Cheltenham General Hospital /ID# 131951
    • Norfolk
      • Norwich、Norfolk、イギリス、NR4 7UY
        • Norfolk and Norwich Univ Hosp /ID# 131953
  • イスラエル
      • Be'er Ya'akov、イスラエル、70300
        • Assaf Harofeh Medical Center /ID# 132830
      • Jerusalem、イスラエル、91031
        • Shaare Zedek Medical Center /ID# 132834
      • Kfar Saba、イスラエル、4428164
        • Meir Medical Center /ID# 132832
      • Ramat Gan、イスラエル、5239424
        • Sheba Medical Center /ID# 132833
  • オランダ
      • Amsterdam、オランダ、1081 HV
        • Vrije Universiteit Medisch Centrum /ID# 131967
      • Eindhoven、オランダ、5623 EJ
        • Catharina Ziekenhuis /ID# 131966
      • Harderwijk、オランダ、3844 DG
        • Ziekenhuis St. Jansdal /ID# 131965
      • Nieuwegein、オランダ、3435 CM
        • St. Antonius Ziekenhuis /ID# 133635
      • S Hertogenbosch、オランダ、5223 GZ
        • Jeroen Bosch Ziekenhuis /ID# 131968
  • オーストラリア
    • New South Wales
      • Kogarah、New South Wales、オーストラリア、2217
        • St George Hospital /ID# 132481
      • Wollongong、New South Wales、オーストラリア、2500
        • Southern Medical Day Care Ctr /ID# 132482
    • South Australia
      • Bedford Park、South Australia、オーストラリア、5042
        • Flinders Centre for Innovation /ID# 134288
    • Tasmania
      • Hobart、Tasmania、オーストラリア、7000
        • Royal Hobart Hospital /ID# 132477
  • カナダ
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 1V7
        • Qe Ii Hsc /Id# 133408
    • Ontario
      • London、Ontario、カナダ、N6A 4L6
        • Victoria Hospital /ID# 132161
      • Windsor、Ontario、カナダ、N9C 3Z4
        • Windsor Regional Hospital /ID# 135989
    • Quebec
      • Quebec City、Quebec、カナダ、G6V 3Z1
        • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155
  • スペイン
      • Alcorcon、スペイン、28922
        • Hospital Universitario Fundacion Alcorcon /ID# 132909
      • Alicante、スペイン、03010
        • Hospital General Universitario Alicante /ID# 132881
      • Barcelona、スペイン、08028
        • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876
      • Barcelona、スペイン、08035
        • Hospital Universitario Vall d'Hebron /ID# 132871
      • Madrid、スペイン、28033
        • MD Anderson Madrid /ID# 132905
      • Madrid、スペイン、28046
        • Hospital Universitario La Paz /ID# 132870
      • Madrid、スペイン、28050
        • Hospital Universitario HM Sanchinarro /ID# 132869
      • Valencia、スペイン、46010
        • Hospital Clinico Universitario de Valencia /ID# 132873
    • Barcelona
      • L'Hospitalet de Llobregat、Barcelona、スペイン、08907
        • Hospital Duran i Reynals /ID# 132879
  • チェコ
      • Liberec、チェコ、602 00
        • Krajska nemocnice Liberec a.s. /ID# 132694
      • Ostrava、チェコ、708 52
        • Univ Hosp Ostrava-Poruba /ID# 132690
      • Pardubice、チェコ、532 03
        • Multiscan s.r.o. /ID# 132689
      • Prague、チェコ、128 08
        • Vseobecna Fakultni Nemocnice /ID# 135118
  • デンマーク
    • Syddanmark
      • Odense C、Syddanmark、デンマーク、5000
        • Odense Universitets Hospital /ID# 131912
  • ドイツ
      • Berlin、ドイツ、12203
        • Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927
      • Grosshansdorf、ドイツ、22927
        • Lungen Clinic Grosshansdorf /ID# 131928
      • Hamburg、ドイツ、20246
        • Univ Klinik Eppendorf Hamburg /ID# 131926
      • Löwenstein、ドイツ、74245
        • Klinik Loewenstein GmbH /ID# 131925
  • ニュージーランド
      • Christchurch、ニュージーランド、8011
        • Canterbury District Health Boa /ID# 132469
      • Wellington、ニュージーランド、6021
        • Wellington Hospital (Capital and Coast District Health Board) /ID# 132470
  • ハンガリー
      • Debrecen、ハンガリー、4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 132742
      • Edelény、ハンガリー、3780
        • Koch Robert Hospital /ID# 133440
      • Farkasgyepu、ハンガリー、8582
        • Veszprem Megyei Tudogyogyintez /ID# 132739
      • Gyor、ハンガリー、9023
        • Petz Aladar Megyei Oktato Korh /ID# 132741
      • Kékesteto、ハンガリー、3233
        • Matrahaza Gyogyintezet /ID# 132743
    • Borsod-Abauj-Zemplen
      • Miskolc、Borsod-Abauj-Zemplen、ハンガリー、3529
        • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441
    • Budapest
      • Budapest XII、Budapest、ハンガリー、1122
        • Orszagos Koranyi Pulmonologiai Intezet /ID# 132738
  • フィンランド
      • Pori、フィンランド、28500
        • Satakunnan Sairaanhoitopiiri /ID# 133632
      • Vaasa、フィンランド、65130
        • Vaasa Central Hospital /ID# 131930
  • ロシア連邦
      • Arkhangelsk、ロシア連邦、163045
        • archangel Clinical Oncology /ID# 132376
      • Balashikha、ロシア連邦、143900
        • Moscow Regional Onc Dispensary /ID# 132381
      • Belgorod、ロシア連邦、308010
        • Belgorod Oncology Dispensary /ID# 142638
      • Moscow、ロシア連邦、125284
        • Moscow Res Onc Inst Hertsen /ID# 132370
      • Murmansk、ロシア連邦、183047
        • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087
      • Orenburg、ロシア連邦、460021
        • Orenburg Regional Clinical Onc /ID# 132371
      • Sankt-Peterburg、ロシア連邦、192148
        • Strategic medical systems LLC /ID# 206383
      • Saransk、ロシア連邦、430005
        • Ogarev Mordovia State Univ /ID# 132377
      • St. Petersburg、ロシア連邦、197342
        • LLC BioEq Ltd. /ID# 132372
      • St. Petersburg、ロシア連邦、197758
        • N.N. Petrov Research Inst Onc /ID# 137084
    • Moskva
      • Moscow、Moskva、ロシア連邦、115478
        • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085
    • Sverdlovskaya Oblast
      • Ekaterinburg、Sverdlovskaya Oblast、ロシア連邦、620043
        • Sverdlovsk Regional Oncology Center Dispensary /ID# 132375
  • 七面鳥
      • Ankara、七面鳥、06100
        • Hacettepe University Medical Faculty /ID# 131913
      • Ankara、七面鳥、06590
        • Ankara Univ Medical Faculty /ID# 131914
      • Bursa、七面鳥、16059
        • Uludag University Medical Faculty /ID# 131915
      • Diyarbakir、七面鳥、21200
        • Dicle Universitesi Tip /ID# 136570
      • Gaziantep、七面鳥、27310
        • Gaziantep Universitesi Med /ID# 131917
      • Izmir、七面鳥、35110
        • Dr. Suat Seren Gogus Has /ID# 136568
      • Malatya、七面鳥、44280
        • Inonu University /ID# 136569
  • 南アフリカ
      • Johannesburg、南アフリカ、2196
        • Sandton Oncology Medical Group /ID# 131774
    • Eastern Cape
      • Port Elizabeth、Eastern Cape、南アフリカ、6006
        • GVI Oncology /ID# 133268
    • Gauteng
      • Pretoria、Gauteng、南アフリカ、0044
        • Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775
      • Pretoria、Gauteng、南アフリカ、0181
        • Mary Potter Oncology Centre /ID# 131776
    • Kwazulu-Natal
      • Durban、Kwazulu-Natal、南アフリカ、4091
        • The Oncology Centre /ID# 131773
    • Western Cape
      • Cape Town、Western Cape、南アフリカ、7460
        • Netcare Oncology Intervent Ctr /ID# 131777
      • Cape Town、Western Cape、南アフリカ、7570
        • Cape Town Oncology Trials /ID# 132734
      • Cape Town、Western Cape、南アフリカ、7700
        • GVI Rondebosch Oncology Centre /ID# 132732
  • 台湾
      • Dalin Township、台湾、622
        • Dalin Tzu Chi General Hospital /ID# 131872
      • Taipei City、台湾、11031
        • Taipei Medical University Hospital /ID# 133817
      • Taipei City、台湾、11217
        • Taipei Veterans General Hosp /ID# 131871
    • Taichung
      • Taichung City、Taichung、台湾、40447
        • China Medical University Hosp /ID# 131870
  • 大韓民国
      • Cheongju、大韓民国、28644
        • Chungbuk National Univ Hosp /ID# 131611
    • Busan Gwang Yeogsi
      • Busan、Busan Gwang Yeogsi、大韓民国、49201
        • Dong-A University Hospital /ID# 131609
    • Gyeonggido
      • Seongnam、Gyeonggido、大韓民国、13620
        • Seoul National Univ Bundang ho /ID# 131610
    • Incheon Gwang Yeogsi
      • Jung-gu、Incheon Gwang Yeogsi、大韓民国、22332
        • Inha University Hospital /ID# 147924
    • Jeonranamdo
      • Gwangju、Jeonranamdo、大韓民国、61469
        • Chonnam National University Hospital /ID# 131612
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、大韓民国、06351
        • Samsung Medical Center /ID# 132471
  • 日本
      • Hiroshima、日本、730-8518
        • Hiroshima Citizens Hospital /ID# 135130
      • Kishiwada、日本、596-8501
        • Kishiwada City Hospital /ID# 136548
    • Aichi
      • Nagoya-shi、Aichi、日本、464-8681
        • Aichi Cancer Center Hospital /ID# 134129
    • Fukuoka
      • Kurume-shi、Fukuoka、日本、830-0011
        • Kurume University Hospital /ID# 134117
    • Hokkaido
      • Sapporo-shi、Hokkaido、日本、060-8648
        • Hokkaido University Hospital /ID# 134123
    • Kanagawa
      • Yokohama-shi、Kanagawa、日本、236-0051
        • Kanagawa Cardiovascular and Respiratory Center /ID# 134127
    • Miyagi
      • Sendai-shi、Miyagi、日本、980-0873
        • Sendai Kousei Hospital /ID# 135491
    • Osaka
      • Osaka-sayama-shi、Osaka、日本、589-8511
        • Kindai University Hospital /ID# 134112
      • Osaka-shi、Osaka、日本、534-0021
        • Osaka City General Hospital /ID# 134115
    • Tokyo
      • Chuo-ku、Tokyo、日本、104-0045
        • National Cancer Center Hospital /ID# 135129
      • Koto-ku、Tokyo、日本、135-8550
        • The Cancer Institute Hospital Of JFCR /ID# 135492
    • Yamaguchi
      • Ube-shi、Yamaguchi、日本、755-0241
        • Yamaguchi - Ube Medical Center /ID# 135284

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
薬：Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
薬：Veliparib
Oral capsule, administered twice daily for 7 days in each 21-day cycle
他の名前：
  • ABT-888
薬：Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
他の名前：
  • アリムタ
アクティブコンパレータ：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.
薬：Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
薬：Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
薬：Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
他の名前：
  • アリムタ
薬：Cisplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
時間枠：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.
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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
時間枠：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.

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
時間枠：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.

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
時間枠：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.
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
時間枠：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.

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
時間枠：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.

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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AbbVie

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年9月30日

一次修了 (実際)

2019年11月14日

研究の完了 (実際)

2020年2月21日

試験登録日

最初に提出

2014年10月9日

QC基準を満たした最初の提出物

2014年10月9日

最初の投稿 (見積もり)

2014年10月15日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月26日

QC基準を満たした最後の更新が送信されました

2021年2月8日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • M14-359
  • 2014-002565-30 (EudraCT番号)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

非扁平上皮非小細胞肺がんの臨床試験

  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    全身性肥満細胞症の患者報告アウトカムアンケート
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ

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