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NCT03117049CompletedPhase 3

Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

A Multicenter, Randomized, Double-Blind Trial in Subjects With Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

Source: ClinicalTrials.gov · Last updated 6 May 2024

Brief summary (registry, in English)

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
550 (actual)
First submitted
12 Apr 2017
Start date
Jun 2017
Primary completion date
Feb 2020
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Diseases
Lung cancer
NCT number
NCT03117049

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 550
  • From Jun 2017 to the primary completion date, Feb 2020
  • 134 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
  • Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
  • Subjects with multiple cancer.

Lab values

  • Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations.

Other

  • Subjects with known ALK translocations.

Who the study is looking for

  • Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
  • Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy
  • Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
  • Subjects who are able to provide tumor tissue specimens.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (134)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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AkashiJapanUnknown status
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AmagasakiJapanUnknown status
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AsahikawaJapanUnknown status
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BeppuJapanUnknown status
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Bunkyo-kuJapanUnknown status
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Bunkyo-kuJapanUnknown status
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ChibaJapanUnknown status
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ChibaJapanUnknown status
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Chuo-kuJapanUnknown status
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Chuo-kuJapanUnknown status
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FuchūJapanUnknown status
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FukuiJapanUnknown status
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FukuokaJapanUnknown status
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FukuokaJapanUnknown status
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FukuokaJapanUnknown status
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FukuokaJapanUnknown status
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GifuJapanUnknown status
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GifuJapanUnknown status
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HabikinoJapanUnknown status
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HamamatsuJapanUnknown status
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HidakaJapanUnknown status
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HigashiibarakiJapanUnknown status
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HimejiJapanUnknown status
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HirakataJapanUnknown status
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HirosakiJapanUnknown status
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HirosakiJapanUnknown status
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HiroshimaJapanUnknown status
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HiroshimaJapanUnknown status
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IizukaJapanUnknown status
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IkomaJapanUnknown status
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IseharaJapanUnknown status
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ItamiJapanUnknown status
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IwakuniJapanUnknown status
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IzumoJapanUnknown status
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JōyōJapanUnknown status
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KanazawaJapanUnknown status
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KanazawaJapanUnknown status
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KanazawaJapanUnknown status
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KasamaJapanUnknown status
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KawasakiJapanUnknown status
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KawasakiJapanUnknown status
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KishiwadaJapanUnknown status
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Kitaadachi-gunJapanUnknown status
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KitakyushuJapanUnknown status
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KiyoseJapanUnknown status
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KobeJapanUnknown status
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KochiJapanUnknown status
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KogaJapanUnknown status
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KōriyamaJapanUnknown status
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KōshiJapanUnknown status
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Koto-kuJapanUnknown status
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KumamotoJapanUnknown status
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KurumeJapanUnknown status
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KyotoJapanUnknown status
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MatsumotoJapanUnknown status
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MatsuyamaJapanUnknown status
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Meguro CityJapanUnknown status
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Minato-kuJapanUnknown status
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Mitaka-shiJapanUnknown status
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MoriokaJapanUnknown status
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NagaokaJapanUnknown status
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NagasakiJapanUnknown status
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NagoyaJapanUnknown status
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NagoyaJapanUnknown status
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NagoyaJapanUnknown status
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NagoyaJapanUnknown status
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Natori-shiJapanUnknown status
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NiigataJapanUnknown status
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NiigataJapanUnknown status
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NishinomiyaJapanUnknown status
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ŌitaJapanUnknown status
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OkayamaJapanUnknown status
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OkayamaJapanUnknown status
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ŌmuraJapanUnknown status
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OsakaJapanUnknown status
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OsakaJapanUnknown status
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OsakaJapanUnknown status
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ŌtaJapanUnknown status
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SagamiharaJapanUnknown status
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SakaiJapanUnknown status
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SapporoJapanUnknown status
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SapporoJapanUnknown status
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SayamaJapanUnknown status
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SendaiJapanUnknown status
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ShibukawaJapanUnknown status
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Shibuya CityJapanUnknown status
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Shinjuku-kuJapanUnknown status
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Shinjuku-KuJapanUnknown status
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Shinjuku-KuJapanUnknown status
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Sunto-gunJapanUnknown status
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tabashi CityJapanUnknown status
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TachikawaJapanUnknown status
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TakarazukaJapanUnknown status
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TokushimaJapanUnknown status
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ToyamaJapanUnknown status
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ToyamaJapanUnknown status
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ToyoakeJapanUnknown status
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ToyonakaJapanUnknown status
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TsuJapanUnknown status
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TsuchiuraJapanUnknown status
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UreshinoJapanUnknown status
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WakayamaJapanUnknown status
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YachiyoJapanUnknown status
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YamaguchiJapanUnknown status
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YokohamaJapanUnknown status
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YokohamaJapanUnknown status
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YokohamaJapanUnknown status
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YonagoJapanUnknown status
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YufuJapanUnknown status
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BusanSouth KoreaUnknown status
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Cheongju-siSouth KoreaUnknown status
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DaeguSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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JinjuSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SuwonSouth KoreaUnknown status
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WŏnjuSouth KoreaUnknown status
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ChanghuaTaiwanUnknown status
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Chiayi CityTaiwanUnknown status
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Kaohsiung CityTaiwanUnknown status
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Kaohsiung CityTaiwanUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.