The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
The Exploratory Study to Evaluate Biomarkers in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer (J-TAIL-2)
1 other identifier
observational
470
1 country
95
Brief Summary
This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
95 active sites
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
First Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedStudy Start
First participant enrolled
April 7, 2021
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
1.8 years
March 19, 2021
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Correlation between PD-L1 SNP and atezolizumab combination therapy
Baseline
Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy
Baseline, Predose of cycle 2 (each cycle is 21 days), and when immune-related adverse event occurs (through study completion, an average of 2 years 5 months)
Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy
Baseline
Study Arms (2)
NSCLC cohort
Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care
ED-SCLC cohort
Patients with extensive disease small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate 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 not 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 Clinical Use 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 Clinical Use 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. However, the samples of dead cases can be used for the analysis of immune microenvironment of small cell lung cancer by disclosing information on this study.
- \<non-small cell lung cancer cohort\>
- \. Patients who are unsuitable for enrolment into the study by the investigator's judgment.
- \<extensive disease small cell lung cancer cohort\>
- \. 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 (95)
Hyogo Cancer Center
Akashi, 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
Fukuoka 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
National Hospital Organization Okinawa National Hospital
Ginowan, Japan
National Hospital Organization Himeji Medical Center
Himeji, Japan
Kansai Medical University Hospital
Hirakata, Japan
Hirosaki University Hospital
Hirosaki, Japan
Hiroshima University Hospital
Hiroshima, Japan
Aso Iizuka Hospital
Iizuka, Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, 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
Kagawa University Hospital
Kagawa, Japan
Kagoshima University Hospital
Kagoshima, Japan
Kanazawa University Hospital
Kanazawa, Japan
Kasukabe Medical Center
Kasukabe, Japan
Hospital of the University of Occupational and Envioronmental Health
Kitakyushu, Japan
Kitakyushu Municipal Medical Center
Kitakyushu, Japan
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose, Japan
Kobe Minimally Invasive Cancer Center
Kobe, Japan
Kobe University Hospital
Kobe, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Kōtoku, Japan
Kurume University Hospital
Kurume, Japan
Kyoto City Hospital
Kyoto, Japan
Kyoto University Hospital
Kyoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Shinshu University Hospital
Matsumoto, Japan
Matsusaka Municipal Hospital
Matsusaka, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Japan
The Jikei University Hospital
Minatoku, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Japan
Aichi Medical University Hospital
Nagakute, Japan
Nagasaki University Hospital
Nagasaki, Japan
Aichi Cancer Center
Nagoya, Japan
Nagoya City University 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
Kindai University Hospital
Ōsaka-sayama, Japan
Gunma Prefectural Cancer Center
Ōta-ku, Japan
Shiga University of Medical Science Hospital
Ōtsu, 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
Teine Keijinkai Hospital
Sapporo, Japan
Sendai Kousei Hospital
Sendai, Japan
Tohoku Medical And Pharmaceutical University Hospital
Sendai, Japan
Tohoku University Hospital
Sendai, 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
Iwate Medical University Hospital
Shiwa-gun, 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 Yamaguchi-Ube Medical Center
Ube, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Japan
Yokohama City University Hospital
Yokohama, Japan
Tottori University Hospital
Yonago, Japan
Oita University Hospital
Yufu, Japan
Biospecimen
The biomarkers which enable to select the appropriate patient in atezolizumab combination therapy are exploratory examined with the 3 methods below. * Analysis of PD-L1 SNPs * Comprehensive analysis of plasma protein expression * Analysis of the immune microenvironment of small cell lung cancer
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Akihiko GENMA
Nippon Medical School
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 26, 2021
Study Start
April 7, 2021
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.