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

Completed

• Conditions: Non-small-Cell Lung Cancer

• Registration Number: NCT03645330
• Lead Sponsor: Chugai Pharmaceutical

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

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2018-08-19
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
18 months survival rate	Baseline up to 18 Months	Percentage of participants alive 18 months after initiation of treatment

Secondary Outcome Measures

Name	Time	Method
12 months survival rate	Up to 12 months	Percentage of participants alive 12 months after initiation of treatment
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.
24 months survival rate	Up to 24 months	Percentage of participants alive 24 months after initiation of treatment
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)
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
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
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
Disease Control Rate(DCR)	Up to 4 years	Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
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
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

Trial Locations

Locations (198)

National Hospital Organization Okinawa National Hospital; 🇯🇵 Ginowan, Japan

National Hospital Organization Asahikawa Medical Center; 🇯🇵 Asahikawa, Japan

Asahikawa Medical University Hospital; 🇯🇵 Asahikawa, Japan

Kobe Minimally Invasive Cancer Center; 🇯🇵 Kobe, Japan

Komatsu Municipal Hospital; 🇯🇵 Komatsu, Japan

Ohta Nishinouchi Hospital; 🇯🇵 Kōriyama, Japan

Juntendo University Hospital; 🇯🇵 Bunkyō-Ku, Japan

Gifu University Hospital; 🇯🇵 Gifu, Japan

National Hospital Organization Kyushu Medical Center; 🇯🇵 Fukuoka, Japan

Aomori Prefectural Central Hospital; 🇯🇵 Aomori, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

Kyoto City Hospital; 🇯🇵 Kyoto, Japan

Kimitsu Chuo Hospital; 🇯🇵 Kisarazu, Japan

Kameda Medical Center; 🇯🇵 Kamogawa, Japan

Kobe City Medical Center General Hospital; 🇯🇵 Kobe, Japan

Kumamoto Regional Medical Center; 🇯🇵 Kumamoto, Japan

National Hospital Organization Tokyo Medical Center; 🇯🇵 Meguro, Japan

Oita Prefectural Hospital; 🇯🇵 Oita, Japan

Shiga General Hospital; 🇯🇵 Moriyama, Japan

Tokyo Saiseikai Central Hospital; 🇯🇵 Minato-Ku, Japan

National Hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya, Japan

Gunma Prefectural Cancer Center; 🇯🇵 Ota, Japan

Niigata University Medical and Dental Hospital; 🇯🇵 Niigata, Japan

Okayama Rosai Hospital; 🇯🇵 Okayama, Japan

Tohoku University Hospital; 🇯🇵 Sendai, Japan

Osaka University Hospital; 🇯🇵 Suita, Japan

Osaki Citizen Hospital; 🇯🇵 Osaki, Japan

Takarazuka City Hospital; 🇯🇵 Takarazuka, Japan

Obihiro Kosei Hospital; 🇯🇵 Obihiro, Japan

Osaka Medical College Hospital; 🇯🇵 Osaka, Japan

Osaka General Medical Center; 🇯🇵 Osaka, Japan

Saitama Cancer Center; 🇯🇵 Saitama, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara, Japan

Saitama medical university International medical Center; 🇯🇵 Saitama, Japan

Kanagawa Cardiovascular and Respiratory Center; 🇯🇵 Yokohama, Japan

Yokohama City University Medical Center; 🇯🇵 Yokohama, Japan

Iwate Medical University Hospital; 🇯🇵 Shiwa-gun, Japan

Ogaki Municipal Hospital; 🇯🇵 Ōgaki, Japan

Yokohama Municipal Citizen's Hospital; 🇯🇵 Yokohama, Japan

Tenri Hospital; 🇯🇵 Tenri, Japan

Yokosuka Kyosai Hospital; 🇯🇵 Yokosuka, Japan

TOYOTA Memorial Hospital; 🇯🇵 Toyota, Japan

Ehime University Hospital; 🇯🇵 Tōon, Japan

Oita University hospital; 🇯🇵 Yufu, Japan

Osaka Toneyama Medical Center; 🇯🇵 Toyonaka, Japan

Tottori University Hospital; 🇯🇵 Yonago, Japan

Kindai University Hospital; 🇯🇵 Ōsaka-sayama, Japan

Shiga University of Medical Science Hospital; 🇯🇵 Ōtsu, Japan

National Hospital Organization Kyoto Medical Center; 🇯🇵 Kyoto, Japan

University Hospital, Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Akita University Hospital; 🇯🇵 Akita, Japan

Akashi Medical Center; 🇯🇵 Akashi, Japan

Hyogo Cancer Center; 🇯🇵 Akashi, Japan

Hyogo Prefectural Amagasaki General Medical Center; 🇯🇵 Amagasaki, Japan

Fujisawa City Hospital; 🇯🇵 Fujisawa, Japan

Fukui Prefectural Hospital; 🇯🇵 Fukui, Japan

Gifu Prefectural General Medical Center; 🇯🇵 Gifu, Japan

Osaka Habikino Medical Center; 🇯🇵 Habikino, Japan

Hamamatsu University Hospital; 🇯🇵 Hamamatsu, Japan

National Hospital Organization Hirosaki National Hospital; 🇯🇵 Hirosaki, Japan

Shimane University Hospital; 🇯🇵 Izumo, Japan

Ibaraki Prefectural Central Hospital; 🇯🇵 Kasama, Japan

Kawasaki Municipal Hospital; 🇯🇵 Kawasaki, Japan

Japan Community Health care Organization Kyushu Hospital; 🇯🇵 Kitakyushu, Japan

Fukujuji Hospital; 🇯🇵 Kiyose, Japan

Kitakyushu Municipal Medical Center; 🇯🇵 Kitakyushu, Japan

National Hospital Organization Kure Medical Center and Chugoku Cancer Center; 🇯🇵 Kure, Japan

Kitano Hospital; 🇯🇵 Osaka, Japan

Saitama Red Cross Hospital; 🇯🇵 Saitama, Japan

Jichi Medical University Hospital; 🇯🇵 Shimotsuke, Japan

KKR Takamatsu Hospital; 🇯🇵 Takamatsu, Japan

University of Tsukuba Hospital; 🇯🇵 Tsukuba, Japan

National Hospital Organization Yamaguchi-Ube Medical Center; 🇯🇵 Ube, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama, Japan

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Japan

Funabashi Municipal Medical Center; 🇯🇵 Funabashi, Japan

Chiba Cancer Center; 🇯🇵 Chiba, Japan

Chiba University Hospital; 🇯🇵 Chiba, Japan

Nippon Medical School Hospital; 🇯🇵 Bunkyō-Ku, Japan

National Hospital Organization Himeji Medical Center; 🇯🇵 Himeji, Japan

Tokyo Medical University Ibaraki Medical Center; 🇯🇵 Ibaraki, Japan

Hiroshima Prefectural Hospital; 🇯🇵 Hiroshima, Japan

Hiroshima University Hospital; 🇯🇵 Hiroshima, Japan

Iizuka Hospital; 🇯🇵 Iizuka, Japan

Nippon Medical School Chiba Hokusoh Hospital; 🇯🇵 Inzai, Japan

Kanto Rosai Hospital; 🇯🇵 Kawasaki, Japan

National Hospital Organization Iwakuni Clinical Center; 🇯🇵 Iwakuni, Japan

Juntendo University Shizuoka Hospital; 🇯🇵 Izunokuni, Japan

Kagawa University Hospital; 🇯🇵 Kagawa, Japan

Isesaki Municipal Hospital; 🇯🇵 Isesaki, Japan

Kagoshima University Hospital; 🇯🇵 Kagoshima, Japan

Tokai University Hospital; 🇯🇵 Isehara, Japan

National Hospital Organization Tokyo National Hospital; 🇯🇵 Kiyose, Japan

Dokkyo Medical University Saitama Medical Center; 🇯🇵 Koshigaya, Japan

Cancer Institute Hospital of Japanese Foundation For Cancer Research; 🇯🇵 Koto-Ku, Japan

Matsusaka Municipal Hospital; 🇯🇵 Matsusaka, Japan

Kurume University Hospital; 🇯🇵 Kurume, Japan

Hospital of the University of Occupational and Envioronmental Health, Japan; 🇯🇵 Kitakyushu, Japan

Kobe University Hospital; 🇯🇵 Kobe, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Japan

Japanese Red Cross Kyoto Daiichi Hospital; 🇯🇵 Kyoto, Japan

Japanese Red Cross Kyoto Daini Hospital; 🇯🇵 Kyoto, Japan

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Gunma University Hospital; 🇯🇵 Maebashi, Japan

Kishiwada City Hospital; 🇯🇵 Kishiwada, Japan

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan

The Jikei University Hospital; 🇯🇵 Minato-Ku, Japan

Ehime Prefectural Central Hospital; 🇯🇵 Matsuyama, Japan

Matsuyama Red Cross Hospital; 🇯🇵 Matsuyama, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama, Japan

Kyorin University Hospital; 🇯🇵 Mitaka, Japan

Aichi Medical University Hospital; 🇯🇵 Nagakute, Japan

Miyazaki Prefectural Miyazaki Hospital; 🇯🇵 Miyazaki, Japan

Iwate Prefectural Central Hospital; 🇯🇵 Morioka, Japan

Japanese Red Cross Society Nagano Hospital; 🇯🇵 Nagano, Japan

Nagasaki University Hospital; 🇯🇵 Nagasaki, Japan

Nagaoka Red Cross Hospital; 🇯🇵 Nagaoka, 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

Nara Prefecture General Medical Center; 🇯🇵 Nara, Japan

Miyagi Cancer Center; 🇯🇵 Natori, Japan

The Hospital of Hyogo College of Medicine; 🇯🇵 Nishinomiya, Japan

Kochi Medical School Hospital; 🇯🇵 Nankoku, Japan

Niigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

Japanese Red Cross Okayama Hospital; 🇯🇵 Okayama, Japan

University of Ryukyus Hospital; 🇯🇵 Okinawa, Japan

Osaka City General Hospital; 🇯🇵 Osaka, Japan

Osaka City University Hospital; 🇯🇵 Osaka, Japan

Osaka Police Hospital; 🇯🇵 Osaka, Japan

Osaka Red Cross Hospital; 🇯🇵 Osaka, Japan

Okayama University Hospital; 🇯🇵 Okayama, Japan

Osaka Saiseikai Nakatsu Hospital; 🇯🇵 Osaka, Japan

Saga University Hospital; 🇯🇵 Saga, Japan

Jichi Medical University Saitama Medical Center; 🇯🇵 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

Sendai Medical Association Hospital; 🇯🇵 Satsumasendai, Japan

Sendai Kousei Hospital; 🇯🇵 Sendai, Japan

NTT Medical Center Tokyo; 🇯🇵 Shinagawa-Ku, Japan

Tosei General Hospital; 🇯🇵 Seto, Japan

Showa University Hospital; 🇯🇵 Shinagawa-Ku, Japan

Center Hospital of the National Center for Global; 🇯🇵 Shinjuku-Ku, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku-Ku, Japan

Tokyo Women's Medical University Hospital; 🇯🇵 Shinjuku-Ku, Japan

Shizuoka Cancer Center; 🇯🇵 Shizuoka, Japan

Shizuoka General Hospital; 🇯🇵 Shizuoka, Japan

Gifu Prefectural Tajimi Hospital; 🇯🇵 Tajimi, Japan

Saiseikai Suita Hospital; 🇯🇵 Suita, Japan

Kagawa Prefectural Central Hospital; 🇯🇵 Takamatsu, Japan

Dokkyo Medical University Hospital; 🇯🇵 Tochigi, Japan

JA Toyama Kouseiren Takaoka Hospital; 🇯🇵 Takaoka, Japan

Toyama Prefectural Central Hospital; 🇯🇵 Toyama, Japan

Tokushima Prefectural Central Hospital; 🇯🇵 Tokushima, Japan

Tokushima University Hospital; 🇯🇵 Tokushima, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Japan

Toyohashi Municipal Hospital; 🇯🇵 Toyohashi, Japan

Tsukuba Medical Center Foundation; 🇯🇵 Tsukuba, Japan

Mie University Hospital; 🇯🇵 Tsu, Japan

Uji-TOKUSHUKAI MEDICAL CENTER; 🇯🇵 Uji, Japan

Saiseikai Utsunomiya Hospital; 🇯🇵 Utsunomiya, Japan

Tochigi Cancer Center; 🇯🇵 Utsunomiya, Japan

Japanese Red Cross Wakayama Medical Center; 🇯🇵 Wakayama, Japan

Yamaguchi University Hospital; 🇯🇵 Yamaguchi, Japan

Wakayama Medical University Hospital; 🇯🇵 Wakayama, Japan

Yamagata University Hospital; 🇯🇵 Yamagata, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama, Japan

Juntendo University Urayasu Hospital; 🇯🇵 Urayasu, Japan

Nagahama City Hospital; 🇯🇵 Nagahama, Japan

Tohoku Medical And Pharmaceutical University Hospital; 🇯🇵 Sendai, Japan

Kyoto-Katsura Hospital; 🇯🇵 Kyoto, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Japan

Toranomon Hospital; 🇯🇵 Minato-Ku, Japan

Osaka International Cancer Institute; 🇯🇵 Osaka, Japan

Saitama Medical University Hospital; 🇯🇵 Saitama, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Japan

Teine Keijinkai Hospital; 🇯🇵 Sapporo, Japan

Kasukabe Medical Center; 🇯🇵 Kasukabe, Japan

Shinshu University Hospital; 🇯🇵 Matsumoto, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan

Kawasaki Medical School General Medical Center; 🇯🇵 Okayama, Japan

Tokyo Medical And Dental University, Medical Hospital; 🇯🇵 Bunkyō-Ku, Japan

Japanese Red Cross Ise Hospital; 🇯🇵 Ise, Japan

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital; 🇯🇵 Bunkyō-Ku, Japan

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka, Japan

Fukushima Medical University Hospital; 🇯🇵 Fukushima, Japan

Hirosaki University Hospital; 🇯🇵 Hirosaki, Japan

Hiroshima City Hiroshima Citizens Hospital; 🇯🇵 Hiroshima, Japan

Sapporo Medical University Hospital; 🇯🇵 Sapporo, Japan

Itami City Hospital; 🇯🇵 Itami, Japan

Ishikawa Prefectural Central Hospital; 🇯🇵 Kanazawa, Japan

Kanazawa University Hospital; 🇯🇵 Kanazawa, Japan

Yamanashi Prefectural Central Hospital; 🇯🇵 Kōfu, Japan

Japan Community Health care Organization Hokkaido Hospital; 🇯🇵 Sapporo, Japan

Japanese Red Cross Medical Center; 🇯🇵 Shibuya, Japan