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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small-Cell Lung Cancer

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 Type: Observational
• Enrollment (Actual): 1026

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18 months survival rate	Percentage of participants alive 18 months after initiation of treatment	Baseline up to 18 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Collaborators: Japan Lung Cancer Society
• Investigators: Principal Investigator: Tetsuya MITSUDOMI, MD/PhD, Kindai University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): July 8, 2021
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: August 19, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Atezolizumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: J-TAIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: After the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No