Non-small Cell Lung CancerNCT04818983
The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
An observational study of Non-small Cell Lung Cancer and Extensive Disease Small Cell Lung Cancer, run by Chugai Pharmaceutical at 95 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Extensive Disease Small Cell Lung Cancer
- How many people
- 470 participants
- Where
- 95 sitesJapan
- Study dates
- 7 Apr 2021to 3 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.
- <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.
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- <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.
Who cannot join
- <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.
Trial locations and contacts
95 sites in 1 country.
95 sites in 1 country
Japan95 sites
Hyogo Cancer Center
Akashi
Asahikawa Medical University Hospital
Asahikawa
National Hospital Organization Asahikawa Medical Center
Asahikawa
Juntendo University Hospital
Bunkyō City
Nippon Medical School Hospital
Bunkyō City
Tokyo Medical And Dental University, Medical Hospital
Bunkyō City
Chiba University Hospital
Chiba
National Cancer Center Hospital
Chūōku
Fukuoka University Hospital
Fukuoka
National Hospital Organization Kyushu Cancer Center
Fukuoka
National Hospital Organization Kyushu Medical Center
Fukuoka
Fukushima Medical University Hospital
Fukushima
National Hospital Organization Okinawa National Hospital
Ginowan
National Hospital Organization Himeji Medical Center
Himeji
Kansai Medical University Hospital
Hirakata
Hirosaki University Hospital
Hirosaki
Hiroshima University Hospital
Hiroshima
Aso Iizuka Hospital
Iizuka
Nippon Medical School Chiba Hokusoh Hospital
Inzai
Tokai University Hospital
Isehara
Teikyo University Hospital
Itabashi-Ku
Itami City Hospital
Itami
National Hospital Organization Iwakuni Clinical Center
Iwakuni
Shimane University Hospital
Izumo
Kagawa University Hospital
Kagawa
Kagoshima University Hospital
Kagoshima
Kanazawa University Hospital
Kanazawa
Kasukabe Medical Center
Kasukabe
Hospital of the University of Occupational and Envioronmental Health
Kitakyushu
Kitakyushu Municipal Medical Center
Kitakyushu
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose
Kobe Minimally Invasive Cancer Center
Kobe
Kobe University Hospital
Kobe
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Kōtoku
Kurume University Hospital
Kurume
Kyoto City Hospital
Kyoto
Kyoto University Hospital
Kyoto
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
Shinshu University Hospital
Matsumoto
Matsusaka Municipal Hospital
Matsusaka
National Hospital Organization Tokyo Medical Center
Meguro-Ku
The Jikei University Hospital
Minatoku
Miyazaki Prefectural Miyazaki Hospital
Miyazaki
Aichi Medical University Hospital
Nagakute
Nagasaki University Hospital
Nagasaki
Aichi Cancer Center
Nagoya
Nagoya City University Hospital
Nagoya
Nagoya University Hospital
Nagoya
National Hospital Organization Nagoya Medical Center
Nagoya
Miyagi Cancer Center
Natori
Niigata Cancer Center Hospital
Niigata
Niigata University Medical and Dental Hospital
Niigata
The Hospital of Hyogo College of Medicine
Nishinomiya
Obihiro Kosei Hospital
Obihiro
Japanese Red Cross Okayama Hospital
Okayama
Kawasaki Medical School General Medical Center
Okayama
Okayama Rosai Hospital
Okayama
Okayama University Hospital
Okayama
Osaka City General Hospital
Osaka
Osaka General Medical Center
Osaka
Osaka International Cancer Institute
Osaka
Kindai University Hospital
Ōsaka-sayama
Gunma Prefectural Cancer Center
Ōta-ku
Shiga University of Medical Science Hospital
Ōtsu
Saitama medical university International medical Center
Saitama
Saitama Prefectural Cancer Center
Saitama
Saitama Red Cross Hospital
Saitama
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai
Hokkaido University Hospital
Sapporo
Teine Keijinkai Hospital
Sapporo
Sendai Kousei Hospital
Sendai
Tohoku Medical And Pharmaceutical University Hospital
Sendai
Tohoku University Hospital
Sendai
Showa University Hospital
Shinagawa-Ku
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku
Keio University Hospital
Shinjuku-Ku
Iwate Medical University Hospital
Shiwa-gun
Osaka University Hospital
Suita
Saiseikai Suita Hospital
Suita
Kagawa Prefectural Central Hospital
Takamatsu
JA Toyama Kouseiren Takaoka Hospital
Takaoka
Takarazuka City Hospital
Takarazuka
Osaka Medical and Pharmaceutical University Hospital
Takatsuki
Tenri Hospital
Tenri
Dokkyo Medical University Hospital
Tochigi
Tokushima Prefectural Central Hospital
Tokushima
Tokushima University Hospital
Tokushima
Toyama Prefectural Central Hospital
Toyama
Fujita Health University Hospital
Toyoake
National Hospital Organization Yamaguchi-Ube Medical Center
Ube
Wakayama Medical University Hospital
Wakayama
Kanagawa Cardiovascular and Respiratory Center
Yokohama
Yokohama City University Hospital
Yokohama
Tottori University Hospital
Yonago
Oita University Hospital
Yufu
About this study
Official title: 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)
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.
- Keywords
- Atezolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PD-L1 SNP and atezolizumab combination therapy
Measured: Baseline
Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start7 Apr 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japan Lung Cancer Society
- Responsible party
- Sponsor
- Investigators
- Akihiko GENMA, Principal investigator, Nippon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818983
- Sponsor's protocol ID
- J-TAIL-2 biomarkers
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Goto Y, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Shimizu J, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Watanabe Y, Katakami N, Kisohara A, Yamaguchi M, Kuroki H, Sugimoto M, Ashimura H, Tanaka M, Gemma A. Plasma Protein Analysis for Biomarker Discovery in Lung Cancer Treated With Atezolizumab Combination Therapy in J-TAIL-2. Cancer Sci. 2026 Jul;117(7):1948-1960. doi: 10.1111/cas.70375. Epub 2026 Apr 21.
PubMed 42014371
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04818983
- Acronym / sponsor ID
- J-TAIL-2 biomarkers
- Keywords
- Atezolizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Japan Lung Cancer Society
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.
- <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.
Key exclusion criteria (4 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between PD-L1 SNP and atezolizumab combination therapy
Time frame: Baseline
Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy
Time frame: 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
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 42014371Goto Y, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Shimizu J, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Watanabe Y, Katakami N, Kisohara A, Yamaguchi M, Kuroki H, Sugimoto M, Ashimura H, Tanaka M, Gemma A. Plasma Protein Analysis for Biomarker Discovery in Lung Cancer Treated With Atezolizumab Combination Therapy in J-TAIL-2. Cancer Sci. 2026 Jul;117(7):1948-1960. doi: 10.1111/cas.70375. Epub 2026 Apr 21.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akihiko GENMA principal investigator
Nippon Medical School
95 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Extensive Disease Small Cell Lung Cancer, run by Chugai Pharmaceutical at 95 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PD-L1 SNP and atezolizumab combination therapy (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.