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A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)

Sponsor
Chugai Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT03645330
Collaborator
Japan Lung Cancer Society (Other)
1,026
Enrollment
198
Locations
34.8
Actual Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary endpoint: 18 months OS, Secondary endpoints: Overall Survival(OS), 12 months survival rate(12mo OS), 24 months survival rate(24mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1026 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)
    Actual Study Start Date :
    Aug 15, 2018
    Actual Primary Completion Date :
    Jul 8, 2021
    Actual Study Completion Date :
    Jul 8, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 18 months survival rate [Baseline up to 18 Months]

      Percentage of participants alive 18 months after initiation of treatment

    Secondary Outcome Measures

    1. Overall Survival(OS) [Up to death (up to 4 years)]

      OS was defined as the time from the first day of study treatment to death due to any cause

    2. 12 months survival rate [Up to 12 months]

      Percentage of participants alive 12 months after initiation of treatment

    3. 24 months survival rate [Up to 24 months]

      Percentage of participants alive 24 months after initiation of treatment

    4. Progression-Free Survival(PFS) [Up to disease progression or death whichever occurs first (up to 4 years)]

      PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)

    5. Time to treatment failure (TTF) [Up to 4 years]

      TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death

    6. Objective Response Rate(ORR) [Up to disease progression or death whichever occurs first (up to 4 years)]

      Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1

    7. Disease Control Rate(DCR) [Up to 4 years]

      Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1

    8. Duration of Response(DOR) [From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)]

      Duration of Response as Assessed by the Investigator According to RECIST v1.1

    9. Percentage of Participants with adverse events(Adverse Reactions) [Up to 4 years]

      The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v4.0

    10. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire [Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)]

      EQ-5D-5L consists of five standardized questions. Evaluate the quality of life by converting the result obtained into scores (range: 1.000 to - 0.025). Higher values give better results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients 20 years of age or older at the time of signed consent.

    • Patients with locally advanced or metastatic non-small cell lung cancer.

    • Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline.

    • Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

    Exclusion Criteria:
    • Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akashi Medical Center Akashi Japan
    2 Hyogo Cancer Center Akashi Japan
    3 Akita University Hospital Akita Japan
    4 Hyogo Prefectural Amagasaki General Medical Center Amagasaki Japan
    5 Aomori Prefectural Central Hospital Aomori Japan
    6 Asahikawa Medical University Hospital Asahikawa Japan
    7 National Hospital Organization Asahikawa Medical Center Asahikawa Japan
    8 Juntendo University Hospital Bunkyō-Ku Japan
    9 Nippon Medical School Hospital Bunkyō-Ku Japan
    10 Tokyo Medical And Dental University, Medical Hospital Bunkyō-Ku Japan
    11 Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital Bunkyō-Ku Japan
    12 Chiba Cancer Center Chiba Japan
    13 Chiba University Hospital Chiba Japan
    14 National Cancer Center Hospital Chuo Ku Japan
    15 Fujisawa City Hospital Fujisawa Japan
    16 Fukui Prefectural Hospital Fukui Japan
    17 Fukuoka University Hospital Fukuoka Japan
    18 Kyushu University Hospital Fukuoka Japan
    19 National Hospital Organization Kyushu Cancer Center Fukuoka Japan
    20 National Hospital Organization Kyushu Medical Center Fukuoka Japan
    21 Fukushima Medical University Hospital Fukushima Japan
    22 Funabashi Municipal Medical Center Funabashi Japan
    23 Gifu Prefectural General Medical Center Gifu Japan
    24 Gifu University Hospital Gifu Japan
    25 National Hospital Organization Okinawa National Hospital Ginowan Japan
    26 Osaka Habikino Medical Center Habikino Japan
    27 Hamamatsu University Hospital Hamamatsu Japan
    28 National Hospital Organization Himeji Medical Center Himeji Japan
    29 Hirosaki University Hospital Hirosaki Japan
    30 National Hospital Organization Hirosaki National Hospital Hirosaki Japan
    31 Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan
    32 Hiroshima Prefectural Hospital Hiroshima Japan
    33 Hiroshima University Hospital Hiroshima Japan
    34 Tokyo Medical University Ibaraki Medical Center Ibaraki Japan
    35 Iizuka Hospital Iizuka Japan
    36 Nippon Medical School Chiba Hokusoh Hospital Inzai Japan
    37 Tokai University Hospital Isehara Japan
    38 Isesaki Municipal Hospital Isesaki Japan
    39 Japanese Red Cross Ise Hospital Ise Japan
    40 Itami City Hospital Itami Japan
    41 National Hospital Organization Iwakuni Clinical Center Iwakuni Japan
    42 Shimane University Hospital Izumo Japan
    43 Juntendo University Shizuoka Hospital Izunokuni Japan
    44 Kagawa University Hospital Kagawa Japan
    45 Kagoshima University Hospital Kagoshima Japan
    46 Kameda Medical Center Kamogawa Japan
    47 Ishikawa Prefectural Central Hospital Kanazawa Japan
    48 Kanazawa University Hospital Kanazawa Japan
    49 Ibaraki Prefectural Central Hospital Kasama Japan
    50 Kasukabe Medical Center Kasukabe Japan
    51 Kanto Rosai Hospital Kawasaki Japan
    52 Kawasaki Municipal Hospital Kawasaki Japan
    53 Kimitsu Chuo Hospital Kisarazu Japan
    54 Kishiwada City Hospital Kishiwada Japan
    55 Hospital of the University of Occupational and Envioronmental Health, Japan Kitakyushu Japan
    56 Japan Community Health care Organization Kyushu Hospital Kitakyushu Japan
    57 Kitakyushu Municipal Medical Center Kitakyushu Japan
    58 Fukujuji Hospital Kiyose Japan
    59 National Hospital Organization Tokyo National Hospital Kiyose Japan
    60 Kobe City Medical Center General Hospital Kobe Japan
    61 Kobe Minimally Invasive Cancer Center Kobe Japan
    62 Kobe University Hospital Kobe Japan
    63 Komatsu Municipal Hospital Komatsu Japan
    64 Dokkyo Medical University Saitama Medical Center Koshigaya Japan
    65 Cancer Institute Hospital of Japanese Foundation For Cancer Research Koto-Ku Japan
    66 Kumamoto Regional Medical Center Kumamoto Japan
    67 Kumamoto University Hospital Kumamoto Japan
    68 Kurashiki Central Hospital Kurashiki Japan
    69 National Hospital Organization Kure Medical Center and Chugoku Cancer Center Kure Japan
    70 Kurume University Hospital Kurume Japan
    71 Japanese Red Cross Kyoto Daiichi Hospital Kyoto Japan
    72 Japanese Red Cross Kyoto Daini Hospital Kyoto Japan
    73 Kyoto City Hospital Kyoto Japan
    74 Kyoto University Hospital Kyoto Japan
    75 Kyoto-Katsura Hospital Kyoto Japan
    76 National Hospital Organization Kyoto Medical Center Kyoto Japan
    77 University Hospital, Kyoto Prefectural University of Medicine Kyoto Japan
    78 Yamanashi Prefectural Central Hospital Kōfu Japan
    79 Ohta Nishinouchi Hospital Kōriyama Japan
    80 Gunma University Hospital Maebashi Japan
    81 Shinshu University Hospital Matsumoto Japan
    82 Matsusaka Municipal Hospital Matsusaka Japan
    83 Ehime Prefectural Central Hospital Matsuyama Japan
    84 Matsuyama Red Cross Hospital Matsuyama Japan
    85 National Hospital Organization Shikoku Cancer Center Matsuyama Japan
    86 National Hospital Organization Tokyo Medical Center Meguro Japan
    87 The Jikei University Hospital Minato-Ku Japan
    88 Tokyo Saiseikai Central Hospital Minato-Ku Japan
    89 Toranomon Hospital Minato-Ku Japan
    90 Kyorin University Hospital Mitaka Japan
    91 Miyazaki Prefectural Miyazaki Hospital Miyazaki Japan
    92 Iwate Prefectural Central Hospital Morioka Japan
    93 Shiga General Hospital Moriyama Japan
    94 Nagahama City Hospital Nagahama Japan
    95 Aichi Medical University Hospital Nagakute Japan
    96 Japanese Red Cross Society Nagano Hospital Nagano Japan
    97 Nagaoka Red Cross Hospital Nagaoka Japan
    98 Nagasaki University Hospital Nagasaki Japan
    99 Aichi Cancer Center Nagoya Japan
    100 Japanese Red Cross Nagoya Daini Hospital Nagoya Japan
    101 Nagoya City West Medical Center Nagoya Japan
    102 Nagoya Ekisaikai Hospital Nagoya Japan
    103 Nagoya University Hospital Nagoya Japan
    104 National Hospital Organization Nagoya Medical Center Nagoya Japan
    105 Kochi Medical School Hospital Nankoku Japan
    106 Nara Prefecture General Medical Center Nara Japan
    107 Miyagi Cancer Center Natori Japan
    108 Niigata Cancer Center Hospital Niigata Japan
    109 Niigata University Medical and Dental Hospital Niigata Japan
    110 The Hospital of Hyogo College of Medicine Nishinomiya Japan
    111 Obihiro Kosei Hospital Obihiro Japan
    112 Oita Prefectural Hospital Oita Japan
    113 Japanese Red Cross Okayama Hospital Okayama Japan
    114 Kawasaki Medical School General Medical Center Okayama Japan
    115 Okayama Rosai Hospital Okayama Japan
    116 Okayama University Hospital Okayama Japan
    117 University of Ryukyus Hospital Okinawa Japan
    118 Kitano Hospital Osaka Japan
    119 Osaka City General Hospital Osaka Japan
    120 Osaka City University Hospital Osaka Japan
    121 Osaka General Medical Center Osaka Japan
    122 Osaka International Cancer Institute Osaka Japan
    123 Osaka Medical College Hospital Osaka Japan
    124 Osaka Police Hospital Osaka Japan
    125 Osaka Red Cross Hospital Osaka Japan
    126 Osaka Saiseikai Nakatsu Hospital Osaka Japan
    127 Osaki Citizen Hospital Osaki Japan
    128 Gunma Prefectural Cancer Center Ota Japan
    129 Kitasato University Hospital Sagamihara Japan
    130 Saga University Hospital Saga Japan
    131 Jichi Medical University Saitama Medical Center Saitama Japan
    132 Saitama Cancer Center Saitama Japan
    133 Saitama Medical University Hospital Saitama Japan
    134 Saitama medical university International medical Center Saitama Japan
    135 Saitama Red Cross Hospital Saitama Japan
    136 National Hospital Organization Kinki-Chuo Chest Medical Center Sakai Japan
    137 Nihonkai General Hospital Sakata Japan
    138 Hokkaido Cancer Center Sapporo Japan
    139 Hokkaido University Hospital Sapporo Japan
    140 Japan Community Health care Organization Hokkaido Hospital Sapporo Japan
    141 Sapporo Medical University Hospital Sapporo Japan
    142 Teine Keijinkai Hospital Sapporo Japan
    143 Sendai Medical Association Hospital Satsumasendai Japan
    144 Sendai Kousei Hospital Sendai Japan
    145 Tohoku Medical And Pharmaceutical University Hospital Sendai Japan
    146 Tohoku University Hospital Sendai Japan
    147 Tosei General Hospital Seto Japan
    148 Japanese Red Cross Medical Center Shibuya Japan
    149 Jichi Medical University Hospital Shimotsuke Japan
    150 NTT Medical Center Tokyo Shinagawa-Ku Japan
    151 Showa University Hospital Shinagawa-Ku Japan
    152 Center Hospital of the National Center for Global Shinjuku-Ku Japan
    153 Keio University Hospital Shinjuku-Ku Japan
    154 Tokyo Medical University Hospital Shinjuku-Ku Japan
    155 Tokyo Women's Medical University Hospital Shinjuku-Ku Japan
    156 Iwate Medical University Hospital Shiwa-gun Japan
    157 Shizuoka Cancer Center Shizuoka Japan
    158 Shizuoka General Hospital Shizuoka Japan
    159 Osaka University Hospital Suita Japan
    160 Saiseikai Suita Hospital Suita Japan
    161 Gifu Prefectural Tajimi Hospital Tajimi Japan
    162 Kagawa Prefectural Central Hospital Takamatsu Japan
    163 KKR Takamatsu Hospital Takamatsu Japan
    164 JA Toyama Kouseiren Takaoka Hospital Takaoka Japan
    165 Takarazuka City Hospital Takarazuka Japan
    166 Tenri Hospital Tenri Japan
    167 Dokkyo Medical University Hospital Tochigi Japan
    168 Tokushima Prefectural Central Hospital Tokushima Japan
    169 Tokushima University Hospital Tokushima Japan
    170 Toyama Prefectural Central Hospital Toyama Japan
    171 Fujita Health University Hospital Toyoake Japan
    172 Toyohashi Municipal Hospital Toyohashi Japan
    173 Osaka Toneyama Medical Center Toyonaka Japan
    174 TOYOTA Memorial Hospital Toyota Japan
    175 Tsukuba Medical Center Foundation Tsukuba Japan
    176 University of Tsukuba Hospital Tsukuba Japan
    177 Mie University Hospital Tsu Japan
    178 Ehime University Hospital Tōon Japan
    179 National Hospital Organization Yamaguchi-Ube Medical Center Ube Japan
    180 Uji-TOKUSHUKAI MEDICAL CENTER Uji Japan
    181 Juntendo University Urayasu Hospital Urayasu Japan
    182 Saiseikai Utsunomiya Hospital Utsunomiya Japan
    183 Tochigi Cancer Center Utsunomiya Japan
    184 Japanese Red Cross Wakayama Medical Center Wakayama Japan
    185 Wakayama Medical University Hospital Wakayama Japan
    186 Yamagata University Hospital Yamagata Japan
    187 Yamaguchi University Hospital Yamaguchi Japan
    188 Kanagawa Cancer Center Yokohama Japan
    189 Kanagawa Cardiovascular and Respiratory Center Yokohama Japan
    190 Yokohama City University Hospital Yokohama Japan
    191 Yokohama City University Medical Center Yokohama Japan
    192 Yokohama Municipal Citizen's Hospital Yokohama Japan
    193 Yokosuka Kyosai Hospital Yokosuka Japan
    194 Tottori University Hospital Yonago Japan
    195 Oita University hospital Yufu Japan
    196 Ogaki Municipal Hospital Ōgaki Japan
    197 Kindai University Hospital Ōsaka-sayama Japan
    198 Shiga University of Medical Science Hospital Ōtsu Japan

    Sponsors and Collaborators

    • Chugai Pharmaceutical
    • Japan Lung Cancer Society

    Investigators

    • Principal Investigator: Tetsuya MITSUDOMI, MD/PhD, Kindai University Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chugai Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT03645330
    Other Study ID Numbers:
    • J-TAIL
    First Posted:
    Aug 24, 2018
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chugai Pharmaceutical
    Atezolizumab
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 22, 2022