Clinical trial NCT03645330: A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)
Official title: Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small-Cell Lung Cancer
Keywords: Atezolizumab
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Japan Lung Cancer Society
First posted: 2018-08-24
Enrollment: 1026
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are planning to provide Atezolizumab monotherapy as the most appropriate medical care for patients and who meet the Eligibility criteria at registration.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 18 months survival rate
timeFrame: Baseline up to 18 Months
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: Up to death (up to 4 years)
measure: 12 months survival rate
timeFrame: Up to 12 months
measure: 24 months survival rate
timeFrame: Up to 24 months
measure: Progression-Free Survival(PFS)
timeFrame: Up to disease progression or death whichever occurs first (up to 4 years)
measure: Time to treatment failure (TTF)
timeFrame: Up to 4 years
measure: Objective Response Rate(ORR)
timeFrame: Up to disease progression or death whichever occurs first (up to 4 years)
measure: Disease Control Rate(DCR)
timeFrame: Up to 4 years
measure: Duration of Response(DOR)
timeFrame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
measure: Percentage of Participants with adverse events(Adverse Reactions)
timeFrame: Up to 4 years
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
timeFrame: Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)
Other outcomes:
Locations:
city: Akashi
country: Japan
facility: Akashi Medical Center
city: Akashi
country: Japan
facility: Hyogo Cancer Center
city: Akita
country: Japan
facility: Akita University Hospital
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
city: Bunkyō-Ku
country: Japan
facility: Juntendo University Hospital
city: Bunkyō-Ku
country: Japan
facility: Nippon Medical School Hospital
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical And Dental University, Medical Hospital
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Fujisawa
country: Japan
facility: Fujisawa City Hospital
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Funabashi
country: Japan
facility: Funabashi Municipal Medical Center
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Ginowan
country: Japan
facility: National Hospital Organization Okinawa National Hospital
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Ibaraki
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
city: Iizuka
country: Japan
facility: Iizuka Hospital
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital
city: Ise
country: Japan
facility: Japanese Red Cross Ise Hospital
city: Itami
country: Japan
facility: Itami City Hospital
city: Iwakuni
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
city: Izumo
country: Japan
facility: Shimane University Hospital
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kamogawa
country: Japan
facility: Kameda Medical Center
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital
city: Kasukabe
country: Japan
facility: Kasukabe Medical Center
city: Kawasaki
country: Japan
facility: Kanto Rosai Hospital
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Hospital
city: Kisarazu
country: Japan
facility: Kimitsu Chuo Hospital
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Envioronmental Health, Japan
city: Kitakyushu
country: Japan
facility: Japan Community Health care Organization Kyushu Hospital
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center
city: Kiyose
country: Japan
facility: Fukujuji Hospital
city: Kiyose
country: Japan
facility: National Hospital Organization Tokyo National Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kobe
country: Japan
facility: Kobe Minimally Invasive Cancer Center
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Komatsu
country: Japan
facility: Komatsu Municipal Hospital
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of Japanese Foundation For Cancer Research
city: Kumamoto
country: Japan
facility: Kumamoto Regional Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Kyoto
country: Japan
facility: Kyoto City Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto-Katsura Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Kōfu
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kōriyama
country: Japan
facility: Ohta Nishinouchi Hospital
city: Maebashi
country: Japan
facility: Gunma University Hospital
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hospital
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Meguro
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
city: Minato-Ku
country: Japan
facility: Tokyo Saiseikai Central Hospital
city: Minato-Ku
country: Japan
facility: Toranomon Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital
city: Morioka
country: Japan
facility: Iwate Prefectural Central Hospital
city: Moriyama
country: Japan
facility: Shiga General Hospital
city: Nagahama
country: Japan
facility: Nagahama City Hospital
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nagano
country: Japan
facility: Japanese Red Cross Society Nagano Hospital
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
city: Nagoya
country: Japan
facility: Nagoya City West Medical Center
city: Nagoya
country: Japan
facility: Nagoya Ekisaikai Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
city: Nara
country: Japan
facility: Nara Prefecture General Medical Center
city: Natori
country: Japan
facility: Miyagi Cancer Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Obihiro
country: Japan
facility: Obihiro Kosei Hospital
city: Oita
country: Japan
facility: Oita Prefectural Hospital
city: Okayama
country: Japan
facility: Japanese Red Cross Okayama Hospital
city: Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center
city: Okayama
country: Japan
facility: Okayama Rosai Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okinawa
country: Japan
facility: University of Ryukyus Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka Medical College Hospital
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
city: Osaki
country: Japan
facility: Osaki Citizen Hospital
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Saitama
country: Japan
facility: Saitama Medical University Hospital
city: Saitama
country: Japan
facility: Saitama medical university International medical Center
city: Saitama
country: Japan
facility: Saitama Red Cross Hospital
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Sakata
country: Japan
facility: Nihonkai General Hospital
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Japan Community Health care Organization Hokkaido Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
city: Satsumasendai
country: Japan
facility: Sendai Medical Association Hospital
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
city: Sendai
country: Japan
facility: Tohoku Medical And Pharmaceutical University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Seto
country: Japan
facility: Tosei General Hospital
city: Shibuya
country: Japan
facility: Japanese Red Cross Medical Center
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shinagawa-Ku
country: Japan
facility: NTT Medical Center Tokyo
city: Shinagawa-Ku
country: Japan
facility: Showa University Hospital
city: Shinjuku-Ku
country: Japan
facility: Center Hospital of the National Center for Global
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
city: Shinjuku-Ku
country: Japan
facility: Tokyo Medical University Hospital
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
city: Tajimi
country: Japan
facility: Gifu Prefectural Tajimi Hospital
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Takamatsu
country: Japan
facility: KKR Takamatsu Hospital
city: Takaoka
country: Japan
facility: JA Toyama Kouseiren Takaoka Hospital
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital
city: Tenri
country: Japan
facility: Tenri Hospital
city: Tochigi
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
city: Toyonaka
country: Japan
facility: Osaka Toneyama Medical Center
city: Toyota
country: Japan
facility: TOYOTA Memorial Hospital
city: Tsukuba
country: Japan
facility: Tsukuba Medical Center Foundation
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Tōon
country: Japan
facility: Ehime University Hospital
city: Ube
country: Japan
facility: National Hospital Organization Yamaguchi-Ube Medical Center
city: Uji
country: Japan
facility: Uji-TOKUSHUKAI MEDICAL CENTER
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
city: Utsunomiya
country: Japan
facility: Saiseikai Utsunomiya Hospital
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
city: Wakayama
country: Japan
facility: Japanese Red Cross Wakayama Medical Center
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
city: Yonago
country: Japan
facility: Tottori University Hospital
city: Yufu
country: Japan
facility: Oita University hospital
city: Ōgaki
country: Japan
facility: Ogaki Municipal Hospital
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
city: Ōtsu
country: Japan
facility: Shiga University of Medical Science Hospital
Study officials:
affiliation: Kindai University Faculty of Medicine
name: Tetsuya MITSUDOMI, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: