The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

NCT ID: NCT04818983

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-07

Study Completion Date

2023-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer Extensive Disease Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\<non-small cell lung cancer cohort\>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with unresectable, advanced and recurrent non-small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. 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\>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with extensive disease small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. 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\>

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Japan Lung Cancer Society

OTHER

Sponsor Role collaborator

Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Akihiko GENMA

Role: PRINCIPAL_INVESTIGATOR

Nippon Medical School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hyogo Cancer Center

Akashi, , Japan

Site Status

Asahikawa Medical University Hospital

Asahikawa, , Japan

Site Status

National Hospital Organization Asahikawa Medical Center

Asahikawa, , Japan

Site Status

Juntendo University Hospital

Bunkyō City, , Japan

Site Status

Nippon Medical School Hospital

Bunkyō City, , Japan

Site Status

Tokyo Medical And Dental University, Medical Hospital

Bunkyō City, , Japan

Site Status

Chiba University Hospital

Chiba, , Japan

Site Status

National Cancer Center Hospital

Chūōku, , Japan

Site Status

Fukuoka University Hospital

Fukuoka, , Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Site Status

Fukushima Medical University Hospital

Fukushima, , Japan

Site Status

National Hospital Organization Okinawa National Hospital

Ginowan, , Japan

Site Status

National Hospital Organization Himeji Medical Center

Himeji, , Japan

Site Status

Kansai Medical University Hospital

Hirakata, , Japan

Site Status

Hirosaki University Hospital

Hirosaki, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Aso Iizuka Hospital

Iizuka, , Japan

Site Status

Nippon Medical School Chiba Hokusoh Hospital

Inzai, , Japan

Site Status

Tokai University Hospital

Isehara, , Japan

Site Status

Teikyo University Hospital

Itabashi-Ku, , Japan

Site Status

Itami City Hospital

Itami, , Japan

Site Status

National Hospital Organization Iwakuni Clinical Center

Iwakuni, , Japan

Site Status

Shimane University Hospital

Izumo, , Japan

Site Status

Kagawa University Hospital

Kagawa, , Japan

Site Status

Kagoshima University Hospital

Kagoshima, , Japan

Site Status

Kanazawa University Hospital

Kanazawa, , Japan

Site Status

Kasukabe Medical Center

Kasukabe, , Japan

Site Status

Hospital of the University of Occupational and Envioronmental Health

Kitakyushu, , Japan

Site Status

Kitakyushu Municipal Medical Center

Kitakyushu, , Japan

Site Status

Japan Anti-Tuberculosis Association Fukujuji Hospital

Kiyose, , Japan

Site Status

Kobe Minimally Invasive Cancer Center

Kobe, , Japan

Site Status

Kobe University Hospital

Kobe, , Japan

Site Status

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Kōtoku, , Japan

Site Status

Kurume University Hospital

Kurume, , Japan

Site Status

Kyoto City Hospital

Kyoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Shinshu University Hospital

Matsumoto, , Japan

Site Status

Matsusaka Municipal Hospital

Matsusaka, , Japan

Site Status

National Hospital Organization Tokyo Medical Center

Meguro-Ku, , Japan

Site Status

The Jikei University Hospital

Minatoku, , Japan

Site Status

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, , Japan

Site Status

Aichi Medical University Hospital

Nagakute, , Japan

Site Status

Nagasaki University Hospital

Nagasaki, , Japan

Site Status

Aichi Cancer Center

Nagoya, , Japan

Site Status

Nagoya City University Hospital

Nagoya, , Japan

Site Status

Nagoya University Hospital

Nagoya, , Japan

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Site Status

Miyagi Cancer Center

Natori, , Japan

Site Status

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Niigata University Medical and Dental Hospital

Niigata, , Japan

Site Status

The Hospital of Hyogo College of Medicine

Nishinomiya, , Japan

Site Status

Obihiro Kosei Hospital

Obihiro, , Japan

Site Status

Japanese Red Cross Okayama Hospital

Okayama, , Japan

Site Status

Kawasaki Medical School General Medical Center

Okayama, , Japan

Site Status

Okayama Rosai Hospital

Okayama, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Osaka City General Hospital

Osaka, , Japan

Site Status

Osaka General Medical Center

Osaka, , Japan

Site Status

Osaka International Cancer Institute

Osaka, , Japan

Site Status

Kindai University Hospital

Ōsaka-sayama, , Japan

Site Status

Gunma Prefectural Cancer Center

Ōta-ku, , Japan

Site Status

Shiga University of Medical Science Hospital

Ōtsu, , Japan

Site Status

Saitama medical university International medical Center

Saitama, , Japan

Site Status

Saitama Prefectural Cancer Center

Saitama, , Japan

Site Status

Saitama Red Cross Hospital

Saitama, , Japan

Site Status

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, , Japan

Site Status

Hokkaido University Hospital

Sapporo, , Japan

Site Status

Teine Keijinkai Hospital

Sapporo, , Japan

Site Status

Sendai Kousei Hospital

Sendai, , Japan

Site Status

Tohoku Medical And Pharmaceutical University Hospital

Sendai, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Showa University Hospital

Shinagawa-Ku, , Japan

Site Status

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, , Japan

Site Status

Keio University Hospital

Shinjuku-Ku, , Japan

Site Status

Iwate Medical University Hospital

Shiwa-gun, , Japan

Site Status

Osaka University Hospital

Suita, , Japan

Site Status

Saiseikai Suita Hospital

Suita, , Japan

Site Status

Kagawa Prefectural Central Hospital

Takamatsu, , Japan

Site Status

JA Toyama Kouseiren Takaoka Hospital

Takaoka, , Japan

Site Status

Takarazuka City Hospital

Takarazuka, , Japan

Site Status

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, , Japan

Site Status

Tenri Hospital

Tenri, , Japan

Site Status

Dokkyo Medical University Hospital

Tochigi, , Japan

Site Status

Tokushima Prefectural Central Hospital

Tokushima, , Japan

Site Status

Tokushima University Hospital

Tokushima, , Japan

Site Status

Toyama Prefectural Central Hospital

Toyama, , Japan

Site Status

Fujita Health University Hospital

Toyoake, , Japan

Site Status

National Hospital Organization Yamaguchi-Ube Medical Center

Ube, , Japan

Site Status

Wakayama Medical University Hospital

Wakayama, , Japan

Site Status

Kanagawa Cardiovascular and Respiratory Center

Yokohama, , Japan

Site Status

Yokohama City University Hospital

Yokohama, , Japan

Site Status

Tottori University Hospital

Yonago, , Japan

Site Status

Oita University Hospital

Yufu, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

J-TAIL-2 biomarkers

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC
NCT05244213 ACTIVE_NOT_RECRUITING PHASE2