NCT03645330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,026

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

198 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2.9 years

First QC Date

August 19, 2018

Last Update Submit

July 20, 2022

Conditions

Keywords

Atezolizumab

Outcome Measures

Primary Outcomes (1)

  • 18 months survival rate

    Percentage of participants alive 18 months after initiation of treatment

    Baseline up to 18 Months

Secondary Outcomes (10)

  • Overall Survival(OS)

    Up to death (up to 4 years)

  • 12 months survival rate

    Up to 12 months

  • 24 months survival rate

    Up to 24 months

  • Progression-Free Survival(PFS)

    Up to disease progression or death whichever occurs first (up to 4 years)

  • Time to treatment failure (TTF)

    Up to 4 years

  • +5 more secondary outcomes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (198)

Akashi Medical Center

Akashi, Japan

Location

Hyogo Cancer Center

Akashi, Japan

Location

Akita University Hospital

Akita, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Japan

Location

Aomori Prefectural Central Hospital

Aomori, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Japan

Location

National Hospital Organization Asahikawa Medical Center

Asahikawa, Japan

Location

Juntendo University Hospital

Bunkyō City, Japan

Location

Nippon Medical School Hospital

Bunkyō City, Japan

Location

Tokyo Medical And Dental University, Medical Hospital

Bunkyō City, Japan

Location

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Bunkyō City, Japan

Location

Chiba Cancer Center

Chiba, Japan

Location

Chiba University Hospital

Chiba, Japan

Location

National Cancer Center Hospital

Chūōku, Japan

Location

Fujisawa City Hospital

Fujisawa, Japan

Location

Fukui Prefectural Hospital

Fukui, Japan

Location

Fukuoka University Hospital

Fukuoka, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Location

Fukushima Medical University Hospital

Fukushima, Japan

Location

Funabashi Municipal Medical Center

Funabashi, Japan

Location

Gifu Prefectural General Medical Center

Gifu, Japan

Location

Gifu University Hospital

Gifu, Japan

Location

National Hospital Organization Okinawa National Hospital

Ginowan, Japan

Location

Osaka Habikino Medical Center

Habikino, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Japan

Location

National Hospital Organization Himeji Medical Center

Himeji, Japan

Location

Hirosaki University Hospital

Hirosaki, Japan

Location

National Hospital Organization Hirosaki National Hospital

Hirosaki, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, Japan

Location

Hiroshima University Hospital

Hiroshima, Japan

Location

Tokyo Medical University Ibaraki Medical Center

Ibaraki, Japan

Location

Iizuka Hospital

Iizuka, Japan

Location

Nippon Medical School Chiba Hokusoh Hospital

Inzai, Japan

Location

Japanese Red Cross Ise Hospital

Ise, Japan

Location

Tokai University Hospital

Isehara, Japan

Location

Isesaki Municipal Hospital

Isesaki, Japan

Location

Itami City Hospital

Itami, Japan

Location

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Japan

Location

Shimane University Hospital

Izumo, Japan

Location

Juntendo University Shizuoka Hospital

Izunokuni, Japan

Location

Kagawa University Hospital

Kagawa, Japan

Location

Kagoshima University Hospital

Kagoshima, Japan

Location

Kameda Medical Center

Kamogawa, Japan

Location

Ishikawa Prefectural Central Hospital

Kanazawa, Japan

Location

Kanazawa University Hospital

Kanazawa, Japan

Location

Ibaraki Prefectural Central Hospital

Kasama, Japan

Location

Kasukabe Medical Center

Kasukabe, Japan

Location

Kanto Rosai Hospital

Kawasaki, Japan

Location

Kawasaki Municipal Hospital

Kawasaki, Japan

Location

Kimitsu Chuo Hospital

Kisarazu, Japan

Location

Kishiwada City Hospital

Kishiwada, Japan

Location

Hospital of the University of Occupational and Envioronmental Health, Japan

Kitakyushu, Japan

Location

Japan Community Health care Organization Kyushu Hospital

Kitakyushu, Japan

Location

Kitakyushu Municipal Medical Center

Kitakyushu, Japan

Location

Fukujuji Hospital

Kiyose, Japan

Location

National Hospital Organization Tokyo National Hospital

Kiyose, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Japan

Location

Kobe Minimally Invasive Cancer Center

Kobe, Japan

Location

Kobe University Hospital

Kobe, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Japan

Location

Komatsu Municipal Hospital

Komatsu, Japan

Location

Dokkyo Medical University Saitama Medical Center

Koshigaya, Japan

Location

Ohta Nishinouchi Hospital

Kōriyama, Japan

Location

Cancer Institute Hospital of Japanese Foundation For Cancer Research

Kōtoku, Japan

Location

Kumamoto Regional Medical Center

Kumamoto, Japan

Location

Kumamoto University Hospital

Kumamoto, Japan

Location

Kurashiki Central Hospital

Kurashiki, Japan

Location

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure, Japan

Location

Kurume University Hospital

Kurume, Japan

Location

Japanese Red Cross Kyoto Daiichi Hospital

Kyoto, Japan

Location

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

Location

Kyoto City Hospital

Kyoto, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

Kyoto-Katsura Hospital

Kyoto, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Japan

Location

Gunma University Hospital

Maebashi, Japan

Location

Shinshu University Hospital

Matsumoto, Japan

Location

Matsusaka Municipal Hospital

Matsusaka, Japan

Location

Ehime Prefectural Central Hospital

Matsuyama, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Location

National Hospital Organization Tokyo Medical Center

Meguro City, Japan

Location

The Jikei University Hospital

Minatoku, Japan

Location

Tokyo Saiseikai Central Hospital

Minatoku, Japan

Location

Toranomon Hospital

Minatoku, Japan

Location

Kyorin University Hospital

Mitaka, Japan

Location

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan

Location

Iwate Prefectural Central Hospital

Morioka, Japan

Location

Shiga General Hospital

Moriyama, Japan

Location

Nagahama City Hospital

Nagahama, Japan

Location

Aichi Medical University Hospital

Nagakute, Japan

Location

Japanese Red Cross Society Nagano Hospital

Nagano, Japan

Location

Nagaoka Red Cross Hospital

Nagaoka, Japan

Location

Nagasaki University Hospital

Nagasaki, Japan

Location

Aichi Cancer Center

Nagoya, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, Japan

Location

Nagoya City West Medical Center

Nagoya, Japan

Location

Nagoya Ekisaikai Hospital

Nagoya, Japan

Location

Nagoya University Hospital

Nagoya, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Location

Kochi Medical School Hospital

Nankoku, Japan

Location

Nara Prefecture General Medical Center

Nara, Japan

Location

Miyagi Cancer Center

Natori, Japan

Location

Niigata Cancer Center Hospital

Niigata, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, Japan

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, Japan

Location

Obihiro Kosei Hospital

Obihiro, Japan

Location

Japanese Red Cross Okayama Hospital

Okayama, Japan

Location

Kawasaki Medical School General Medical Center

Okayama, Japan

Location

Okayama Rosai Hospital

Okayama, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

University of Ryukyus Hospital

Okinawa, Japan

Location

Kitano Hospital

Osaka, Japan

Location

Osaka City General Hospital

Osaka, Japan

Location

Osaka City University Hospital

Osaka, Japan

Location

Osaka General Medical Center

Osaka, Japan

Location

Osaka International Cancer Institute

Osaka, Japan

Location

Osaka Medical College Hospital

Osaka, Japan

Location

Osaka Police Hospital

Osaka, Japan

Location

Osaka Red Cross Hospital

Osaka, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Japan

Location

Oita Prefectural Hospital

Ōita, Japan

Location

Kindai University Hospital

Ōsaka-sayama, Japan

Location

Osaki Citizen Hospital

Ōsaki, Japan

Location

Gunma Prefectural Cancer Center

Ōta-ku, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Japan

Location

Saga University Hospital

Saga, Japan

Location

Kitasato University Hospital

Sagamihara, Japan

Location

Jichi Medical University Saitama Medical Center

Saitama, Japan

Location

Saitama Cancer Center

Saitama, Japan

Location

Saitama Medical University Hospital

Saitama, Japan

Location

Saitama medical university International medical Center

Saitama, Japan

Location

Saitama Red Cross Hospital

Saitama, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, Japan

Location

Nihonkai General Hospital

Sakata, Japan

Location

Hokkaido Cancer Center

Sapporo, Japan

Location

Hokkaido University Hospital

Sapporo, Japan

Location

Japan Community Health care Organization Hokkaido Hospital

Sapporo, Japan

Location

Sapporo Medical University Hospital

Sapporo, Japan

Location

Teine Keijinkai Hospital

Sapporo, Japan

Location

Sendai Medical Association Hospital

Sendai, Japan

Location

Sendai Kousei Hospital

Sendai, Japan

Location

Tohoku Medical And Pharmaceutical University Hospital

Sendai, Japan

Location

Tohoku University Hospital

Sendai, Japan

Location

Tosei General Hospital

Seto, Japan

Location

Japanese Red Cross Medical Center

Shibuya City, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Japan

Location

NTT Medical Center Tokyo

Shinagawa-Ku, Japan

Location

Showa University Hospital

Shinagawa-Ku, Japan

Location

Center Hospital of the National Center for Global

Shinjuku-Ku, Japan

Location

Keio University Hospital

Shinjuku-Ku, Japan

Location

Tokyo Medical University Hospital

Shinjuku-Ku, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Japan

Location

Iwate Medical University Hospital

Shiwa-gun, Japan

Location

Shizuoka Cancer Center

Shizuoka, Japan

Location

Shizuoka General Hospital

Shizuoka, Japan

Location

Osaka University Hospital

Suita, Japan

Location

Saiseikai Suita Hospital

Suita, Japan

Location

Gifu Prefectural Tajimi Hospital

Tajimi, Japan

Location

Kagawa Prefectural Central Hospital

Takamatsu, Japan

Location

KKR Takamatsu Hospital

Takamatsu, Japan

Location

JA Toyama Kouseiren Takaoka Hospital

Takaoka, Japan

Location

Takarazuka City Hospital

Takarazuka, Japan

Location

Tenri Hospital

Tenri, Japan

Location

Dokkyo Medical University Hospital

Tochigi, Japan

Location

Tokushima Prefectural Central Hospital

Tokushima, Japan

Location

Tokushima University Hospital

Tokushima, Japan

Location

Toyama Prefectural Central Hospital

Toyama, Japan

Location

Fujita Health University Hospital

Toyoake, Japan

Location

Toyohashi Municipal Hospital

Toyohashi, Japan

Location

Osaka Toneyama Medical Center

Toyonaka, Japan

Location

TOYOTA Memorial Hospital

Toyota, Japan

Location

Ehime University Hospital

Tōon, Japan

Location

Mie University Hospital

Tsu, Japan

Location

Tsukuba Medical Center Foundation

Tsukuba, Japan

Location

University of Tsukuba Hospital

Tsukuba, Japan

Location

National Hospital Organization Yamaguchi-Ube Medical Center

Ube, Japan

Location

Uji-TOKUSHUKAI MEDICAL CENTER

Uji, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, Japan

Location

Saiseikai Utsunomiya Hospital

Utsunomiya, Japan

Location

Tochigi Cancer Center

Utsunomiya, Japan

Location

Japanese Red Cross Wakayama Medical Center

Wakayama, Japan

Location

Wakayama Medical University Hospital

Wakayama, Japan

Location

Yamagata University Hospital

Yamagata, Japan

Location

Yamaguchi University Hospital

Yamaguchi, Japan

Location

Kanagawa Cancer Center

Yokohama, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Japan

Location

Yokohama City University Hospital

Yokohama, Japan

Location

Yokohama City University Medical Center

Yokohama, Japan

Location

Yokohama Municipal Citizen's Hospital

Yokohama, Japan

Location

Yokosuka Kyosai Hospital

Yokosuka, Japan

Location

Tottori University Hospital

Yonago, Japan

Location

Oita University hospital

Yufu, Japan

Location

Related Publications (1)

  • Mouri A, Kagamu H, Tamada K, Nishio M, Akamatsu H, Goto Y, Hayashi H, Miura S, Gemma A, Yoshino I, Misumi T, Saito R, Yanagitani N, Masaki F, Nokihara H, Nishino K, Seike M, Hase T, Hataji O, Takeoka H, Kawashima Y, Kuroki H, Sugimoto M, Kuriki H, Mitsudomi T. Analysis of Peripheral T Cell Profiling and Plasma Proteomics in Advanced NSCLC Patients Treated With Atezolizumab. Cancer Sci. 2026 Feb 2. doi: 10.1111/cas.70310. Online ahead of print.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tetsuya MITSUDOMI, MD/PhD

    Kindai University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2018

First Posted

August 24, 2018

Study Start

August 15, 2018

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the end of the study

Locations