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

Non-small-Cell Lung Cancer Clinical Trial

Official title:

Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645330
• Other study ID #: J-TAIL
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2022
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1026
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-Cell Lung Cancer

Locations

Country	Name	City	State
Japan	Akashi Medical Center	Akashi
Japan	Hyogo Cancer Center	Akashi
Japan	Akita University Hospital	Akita
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki
Japan	Aomori Prefectural Central Hospital	Aomori
Japan	Asahikawa Medical University Hospital	Asahikawa
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa
Japan	Juntendo University Hospital	Bunkyo-Ku
Japan	Nippon Medical School Hospital	Bunkyo-Ku
Japan	Tokyo Medical And Dental University, Medical Hospital	Bunkyo-Ku
Japan	Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital	Bunkyo-Ku
Japan	Chiba Cancer Center	Chiba
Japan	Chiba University Hospital	Chiba
Japan	National Cancer Center Hospital	Chuo Ku
Japan	Fujisawa City Hospital	Fujisawa
Japan	Fukui Prefectural Hospital	Fukui
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Funabashi Municipal Medical Center	Funabashi
Japan	Gifu Prefectural General Medical Center	Gifu
Japan	Gifu University Hospital	Gifu
Japan	National Hospital Organization Okinawa National Hospital	Ginowan
Japan	Osaka Habikino Medical Center	Habikino
Japan	Hamamatsu University Hospital	Hamamatsu
Japan	National Hospital Organization Himeji Medical Center	Himeji
Japan	Hirosaki University Hospital	Hirosaki
Japan	National Hospital Organization Hirosaki National Hospital	Hirosaki
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Tokyo Medical University Ibaraki Medical Center	Ibaraki
Japan	Iizuka Hospital	Iizuka
Japan	Nippon Medical School Chiba Hokusoh Hospital	Inzai
Japan	Japanese Red Cross Ise Hospital	Ise
Japan	Tokai University Hospital	Isehara
Japan	Isesaki Municipal Hospital	Isesaki
Japan	Itami City Hospital	Itami
Japan	National Hospital Organization Iwakuni Clinical Center	Iwakuni
Japan	Shimane University Hospital	Izumo
Japan	Juntendo University Shizuoka Hospital	Izunokuni
Japan	Kagawa University Hospital	Kagawa
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kameda Medical Center	Kamogawa
Japan	Ishikawa Prefectural Central Hospital	Kanazawa
Japan	Kanazawa University Hospital	Kanazawa
Japan	Ibaraki Prefectural Central Hospital	Kasama
Japan	Kasukabe Medical Center	Kasukabe
Japan	Kanto Rosai Hospital	Kawasaki
Japan	Kawasaki Municipal Hospital	Kawasaki
Japan	Kimitsu Chuo Hospital	Kisarazu
Japan	Kishiwada City Hospital	Kishiwada
Japan	Hospital of the University of Occupational and Envioronmental Health, Japan	Kitakyushu
Japan	Japan Community Health care Organization Kyushu Hospital	Kitakyushu
Japan	Kitakyushu Municipal Medical Center	Kitakyushu
Japan	Fukujuji Hospital	Kiyose
Japan	National Hospital Organization Tokyo National Hospital	Kiyose
Japan	Kobe City Medical Center General Hospital	Kobe
Japan	Kobe Minimally Invasive Cancer Center	Kobe
Japan	Kobe University Hospital	Kobe
Japan	Yamanashi Prefectural Central Hospital	Kofu
Japan	Komatsu Municipal Hospital	Komatsu
Japan	Ohta Nishinouchi Hospital	Koriyama
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya
Japan	Cancer Institute Hospital of Japanese Foundation For Cancer Research	Koto-Ku
Japan	Kumamoto Regional Medical Center	Kumamoto
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki
Japan	National Hospital Organization Kure Medical Center and Chugoku Cancer Center	Kure
Japan	Kurume University Hospital	Kurume
Japan	Japanese Red Cross Kyoto Daiichi Hospital	Kyoto
Japan	Japanese Red Cross Kyoto Daini Hospital	Kyoto
Japan	Kyoto City Hospital	Kyoto
Japan	Kyoto University Hospital	Kyoto
Japan	Kyoto-Katsura Hospital	Kyoto
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	Gunma University Hospital	Maebashi
Japan	Shinshu University Hospital	Matsumoto
Japan	Matsusaka Municipal Hospital	Matsusaka
Japan	Ehime Prefectural Central Hospital	Matsuyama
Japan	Matsuyama Red Cross Hospital	Matsuyama
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama
Japan	National Hospital Organization Tokyo Medical Center	Meguro
Japan	The Jikei University Hospital	Minato-Ku
Japan	Tokyo Saiseikai Central Hospital	Minato-Ku
Japan	Toranomon Hospital	Minato-Ku
Japan	Kyorin University Hospital	Mitaka
Japan	Miyazaki Prefectural Miyazaki Hospital	Miyazaki
Japan	Iwate Prefectural Central Hospital	Morioka
Japan	Shiga General Hospital	Moriyama
Japan	Nagahama City Hospital	Nagahama
Japan	Aichi Medical University Hospital	Nagakute
Japan	Japanese Red Cross Society Nagano Hospital	Nagano
Japan	Nagaoka Red Cross Hospital	Nagaoka
Japan	Nagasaki University Hospital	Nagasaki
Japan	Aichi Cancer Center	Nagoya
Japan	Japanese Red Cross Nagoya Daini Hospital	Nagoya
Japan	Nagoya City West Medical Center	Nagoya
Japan	Nagoya Ekisaikai Hospital	Nagoya
Japan	Nagoya University Hospital	Nagoya
Japan	National Hospital Organization Nagoya Medical Center	Nagoya
Japan	Kochi Medical School Hospital	Nankoku
Japan	Nara Prefecture General Medical Center	Nara
Japan	Miyagi Cancer Center	Natori
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	The Hospital of Hyogo College of Medicine	Nishinomiya
Japan	Obihiro Kosei Hospital	Obihiro
Japan	Ogaki Municipal Hospital	Ogaki
Japan	Oita Prefectural Hospital	Oita
Japan	Japanese Red Cross Okayama Hospital	Okayama
Japan	Kawasaki Medical School General Medical Center	Okayama
Japan	Okayama Rosai Hospital	Okayama
Japan	Okayama University Hospital	Okayama
Japan	University of Ryukyus Hospital	Okinawa
Japan	Kitano Hospital	Osaka
Japan	Osaka City General Hospital	Osaka
Japan	Osaka City University Hospital	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Osaka Medical College Hospital	Osaka
Japan	Osaka Police Hospital	Osaka
Japan	Osaka Red Cross Hospital	Osaka
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Kindai University Hospital	Osaka-sayama
Japan	Osaki Citizen Hospital	Osaki
Japan	Gunma Prefectural Cancer Center	Ota
Japan	Shiga University of Medical Science Hospital	Otsu
Japan	Saga University Hospital	Saga
Japan	Kitasato University Hospital	Sagamihara
Japan	Jichi Medical University Saitama Medical Center	Saitama
Japan	Saitama Cancer Center	Saitama
Japan	Saitama Medical University Hospital	Saitama
Japan	Saitama medical university International medical Center	Saitama
Japan	Saitama Red Cross Hospital	Saitama
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai
Japan	Nihonkai General Hospital	Sakata
Japan	Hokkaido Cancer Center	Sapporo
Japan	Hokkaido University Hospital	Sapporo
Japan	Japan Community Health care Organization Hokkaido Hospital	Sapporo
Japan	Sapporo Medical University Hospital	Sapporo
Japan	Teine Keijinkai Hospital	Sapporo
Japan	Sendai Medical Association Hospital	Satsumasendai
Japan	Sendai Kousei Hospital	Sendai
Japan	Tohoku Medical And Pharmaceutical University Hospital	Sendai
Japan	Tohoku University Hospital	Sendai
Japan	Tosei General Hospital	Seto
Japan	Japanese Red Cross Medical Center	Shibuya
Japan	Jichi Medical University Hospital	Shimotsuke
Japan	NTT Medical Center Tokyo	Shinagawa-Ku
Japan	Showa University Hospital	Shinagawa-Ku
Japan	Center Hospital of the National Center for Global	Shinjuku-Ku
Japan	Keio University Hospital	Shinjuku-Ku
Japan	Tokyo Medical University Hospital	Shinjuku-Ku
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku
Japan	Iwate Medical University Hospital	Shiwa-gun
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Shizuoka General Hospital	Shizuoka
Japan	Osaka University Hospital	Suita
Japan	Saiseikai Suita Hospital	Suita
Japan	Gifu Prefectural Tajimi Hospital	Tajimi
Japan	Kagawa Prefectural Central Hospital	Takamatsu
Japan	KKR Takamatsu Hospital	Takamatsu
Japan	JA Toyama Kouseiren Takaoka Hospital	Takaoka
Japan	Takarazuka City Hospital	Takarazuka
Japan	Tenri Hospital	Tenri
Japan	Dokkyo Medical University Hospital	Tochigi
Japan	Tokushima Prefectural Central Hospital	Tokushima
Japan	Tokushima University Hospital	Tokushima
Japan	Ehime University Hospital	Toon
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Fujita Health University Hospital	Toyoake
Japan	Toyohashi Municipal Hospital	Toyohashi
Japan	Osaka Toneyama Medical Center	Toyonaka
Japan	TOYOTA Memorial Hospital	Toyota
Japan	Mie University Hospital	Tsu
Japan	Tsukuba Medical Center Foundation	Tsukuba
Japan	University of Tsukuba Hospital	Tsukuba
Japan	National Hospital Organization Yamaguchi-Ube Medical Center	Ube
Japan	Uji-TOKUSHUKAI MEDICAL CENTER	Uji
Japan	Juntendo University Urayasu Hospital	Urayasu
Japan	Saiseikai Utsunomiya Hospital	Utsunomiya
Japan	Tochigi Cancer Center	Utsunomiya
Japan	Japanese Red Cross Wakayama Medical Center	Wakayama
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Yamagata University Hospital	Yamagata
Japan	Yamaguchi University Hospital	Yamaguchi
Japan	Kanagawa Cancer Center	Yokohama
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama
Japan	Yokohama City University Hospital	Yokohama
Japan	Yokohama City University Medical Center	Yokohama
Japan	Yokohama Municipal Citizen's Hospital	Yokohama
Japan	Yokosuka Kyosai Hospital	Yokosuka
Japan	Tottori University Hospital	Yonago
Japan	Oita University hospital	Yufu

Sponsors (2)

Lead Sponsor	Collaborator
Chugai Pharmaceutical	Japan Lung Cancer Society

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18 months survival rate	Percentage of participants alive 18 months after initiation of treatment	Baseline up to 18 Months
Secondary	Overall Survival(OS)	OS was defined as the time from the first day of study treatment to death due to any cause	Up to death (up to 4 years)
Secondary	12 months survival rate	Percentage of participants alive 12 months after initiation of treatment	Up to 12 months
Secondary	24 months survival rate	Percentage of participants alive 24 months after initiation of treatment	Up to 24 months
Secondary	Progression-Free Survival(PFS)	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)	Up to disease progression or death whichever occurs first (up to 4 years)
Secondary	Time to treatment failure (TTF)	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	Up to 4 years
Secondary	Objective Response Rate(ORR)	Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1	Up to disease progression or death whichever occurs first (up to 4 years)
Secondary	Disease Control Rate(DCR)	Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1	Up to 4 years
Secondary	Duration of Response(DOR)	Duration of Response as Assessed by the Investigator According to RECIST v1.1	From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
Secondary	Percentage of Participants with adverse events(Adverse Reactions)	The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v4.0	Up to 4 years
Secondary	EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire	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.	Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)