Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
1 other identifier
observational
1,221
1 country
148
Brief Summary
This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Typical duration for all trials
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
August 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2023
CompletedApril 2, 2024
April 1, 2024
2.5 years
August 2, 2020
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12 months survival rate
Percentage of participants alive 12 months after initiation of treatment
Baseline up to 12 Months
Secondary Outcomes (11)
Overall Survival
Up to death (up to 3 years)
6 moths survival rate
Up to 6 months
18 moths survival rate
Up to 18 months
Progression-Free Survival(PFS)
Up to disease progression or death whichever occurs first (up to 3 years)
Time to treatment failure (TTF)
Up to 3 years
- +6 more secondary outcomes
Study Arms (2)
NSCLC cohort (N=800)
Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
ED-SCLC cohort (N=400)
Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
Eligibility Criteria
Patients who are planning to provide Atezolizumab combination therapy as the most appropriate medical care for patients and who meet the Eligibility criteria at registration.
You may qualify if:
- \< non-small cell lung cancer cohort\>
- Patients 20 years of age or older at the time of signed consent.
- Patients with unresectable, advanced and recurrent non-small cell lung cancer.
- Patients who are scheduled to start atezolizumab combination therapy in clinical practice, 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.
- \<extensive disease small cell lung cancer cohort\>
- Patients 20 years of age or older at the time of signed consent.
- Patients with extensive disease small cell lung cancer.
- Patients who are scheduled to start atezolizumab combination therapy in clinical practice, 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:
- \< non-small cell lung cancer cohort\> (1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
- \<extensive disease small cell lung cancer cohort\>
- (1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chugai Pharmaceuticallead
- Japan Lung Cancer Societycollaborator
Study Sites (148)
Akashi Medical Center
Akashi, Japan
Hyogo Cancer Center
Akashi, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Japan
Asahikawa Medical University Hospital
Asahikawa, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Japan
Juntendo University Hospital
Bunkyō City, Japan
Nippon Medical School Hospital
Bunkyō City, Japan
Tokyo Medical And Dental University, Medical Hospital
Bunkyō City, Japan
Chiba University Hospital
Chiba, Japan
National Cancer Center Hospital
Chūōku, 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
Gifu Prefectural General Medical Center
Gifu, Japan
National Hospital Organization Okinawa National Hospital
Ginowan, Japan
Hamamatsu University Hospital
Hamamatsu, Japan
National Hospital Organization Himeji Medical Center
Himeji, Japan
Kansai Medical University Hospital
Hirakata, Japan
Hirosaki University Hospital
Hirosaki, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Hiroshima Prefectural Hospital
Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Japan
Aso Iizuka Hospital
Iizuka, Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, Japan
Japanese Red Cross Ise Hospital
Ise, Japan
Tokai University Hospital
Isehara, Japan
Teikyo University Hospital
Itabashi-Ku, 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
Kishiwada City Hospital
Kishiwada, Japan
Hospital of the University of Occupational and Envioronmental Health
Kitakyushu, Japan
Japan Community Health care Organization Kyushu Hospital
Kitakyushu, Japan
Kitakyushu Municipal Medical Center
Kitakyushu, Japan
Japan Anti-Tuberculosis Association 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
Dokkyo Medical University Saitama Medical Center
Koshigaya, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Kōtoku, Japan
Kurashiki Central Hospital
Kurashiki, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer
Kure, Japan
Kurume University Hospital
Kurume, 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
Shinshu University Hospital
Matsumoto, Japan
Matsusaka Municipal Hospital
Matsusaka, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Japan
The Jikei University Hospital
Minatoku, Japan
Tokyo Saiseikai Central Hospital
Minatoku, Japan
Kyorin University Hospital
Mitaka, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Japan
Nagahama City Hospital
Nagahama, Japan
Aichi Medical University Hospital
Nagakute, Japan
Nagasaki University Hospital
Nagasaki, Japan
Aichi Cancer Center
Nagoya, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Japan
Nagoya City University Hospital
Nagoya, Japan
Nagoya Ekisaikai Hospital
Nagoya, Japan
Nagoya University Hospital
Nagoya, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 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
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
Osaka City General Hospital
Osaka, Japan
Osaka General Medical Center
Osaka, Japan
Osaka International Cancer Institute
Osaka, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan
Ogaki Municipal Hospital
Ōgaki, Japan
Oita Prefectural Hospital
Ōita, Japan
Kindai University Hospital
Ōsaka-sayama, Japan
Osaki Citizen Hospital
Ōsaki, Japan
Gunma Prefectural Cancer Center
Ōta-ku, Japan
Shiga University of Medical Science Hospital
Ōtsu, Japan
Saga University Hospital
Saga, Japan
Kitasato University Hospital
Sagamihara, Japan
Jichi Medical University Saitama Medical Center
Saitama, Japan
Saitama medical university International medical Center
Saitama, Japan
Saitama Prefectural Cancer Center
Saitama, Japan
Saitama Red Cross Hospital
Saitama, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Japan
Hokkaido University Hospital
Sapporo, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Japan
Sapporo Medical University Hospital
Sapporo, Japan
Teine Keijinkai Hospital
Sapporo, Japan
Sendai Kousei Hospital
Sendai, Japan
Tohoku Medical And Pharmaceutical University Hospital
Sendai, Japan
Tohoku University Hospital
Sendai, Japan
Japanese Red Cross Medical Center
Shibuya-Ku, Japan
Jichi Medical University Hospital
Shimotsuke, Japan
Showa University Hospital
Shinagawa-Ku, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Japan
Keio University Hospital
Shinjuku-Ku, Japan
Tokyo 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
Kagawa Prefectural Central Hospital
Takamatsu, Japan
JA Toyama Kouseiren Takaoka Hospital
Takaoka, Japan
Takarazuka City Hospital
Takarazuka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan
Tenri Hospital
Tenri, Japan
Dokkyo Medical University Hospital
Tochigi, Japan
Tokushima Prefectural Central Hospital
Tokushima, Japan
Tokushima University Hospital
Tokushima, Japan
Toyama Prefectural Central Hospital
Toyama, Japan
Fujita Health University Hospital
Toyoake, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka, Japan
TOYOTA Memorial Hospital
Toyota, Japan
Ehime University Hospital
Tōon, Japan
Tsukuba Medical Center Hospital
Tsukuba, Japan
University of Tsukuba Hospital
Tsukuba, Japan
National Hospital Organization Yamaguchi-Ube Medical Center
Ube, Japan
Juntendo University Urayasu Hospital
Urayasu, Japan
Japanese Red Cross Wakayama Medical Center
Wakayama, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Kanagawa Cancer Center
Yokohama, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Japan
Yokohama City University Hospital
Yokohama, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Japan
Yokosuka Kyosai Hospital
Yokosuka, Japan
Tottori University Hospital
Yonago, Japan
Oita University Hospital
Yufu, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Akihiko GENMA
Nippon Medical School Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2020
First Posted
August 6, 2020
Study Start
August 21, 2020
Primary Completion
February 3, 2023
Study Completion
February 3, 2023
Last Updated
April 2, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After the end of the study
All IPD that underlie results in a publication