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Non-small Cell Lung CancerNCT04501497

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 148 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
How many people
1,221 participants
Where
148 sitesJapan
Study dates
21 Aug 2020to 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
  • 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

  • < 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>
Show all 10Show fewer
  • 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.

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

Trial locations and contacts

148 sites in 1 country.

148 sites in 1 country

Japan148 sites

  • Akashi Medical Center

    Akashi

  • Hyogo Cancer Center

    Akashi

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki

  • 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

  • Fujisawa City Hospital

    Fujisawa

  • Fukui Prefectural Hospital

    Fukui

  • Fukuoka University Hospital

    Fukuoka

  • Kyushu University Hospital

    Fukuoka

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka

  • National Hospital Organization Kyushu Medical Center

    Fukuoka

  • Fukushima Medical University Hospital

    Fukushima

  • Gifu Prefectural General Medical Center

    Gifu

  • National Hospital Organization Okinawa National Hospital

    Ginowan

  • Hamamatsu University Hospital

    Hamamatsu

  • National Hospital Organization Himeji Medical Center

    Himeji

  • Kansai Medical University Hospital

    Hirakata

  • Hirosaki University Hospital

    Hirosaki

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima

  • Hiroshima Prefectural Hospital

    Hiroshima

  • Hiroshima University Hospital

    Hiroshima

  • Aso Iizuka Hospital

    Iizuka

  • Nippon Medical School Chiba Hokusoh Hospital

    Inzai

  • Japanese Red Cross Ise Hospital

    Ise

  • Tokai University Hospital

    Isehara

  • Itami City Hospital

    Itami

  • National Hospital Organization Iwakuni Clinical Center

    Iwakuni

  • Shimane University Hospital

    Izumo

  • Juntendo University Shizuoka Hospital

    Izunokuni

  • Kagawa University Hospital

    Kagawa

  • Kagoshima University Hospital

    Kagoshima

  • Kameda Medical Center

    Kamogawa

  • Ishikawa Prefectural Central Hospital

    Kanazawa

  • Kanazawa University Hospital

    Kanazawa

  • Ibaraki Prefectural Central Hospital

    Kasama

  • Kasukabe Medical Center

    Kasukabe

  • Kishiwada City Hospital

    Kishiwada

  • Hospital of the University of Occupational and Envioronmental Health

    Kitakyushu

  • Japan Community Health care Organization Kyushu Hospital

    Kitakyushu

  • Kitakyushu Municipal Medical Center

    Kitakyushu

  • Japan Anti-Tuberculosis Association Fukujuji Hospital

    Kiyose

  • National Hospital Organization Tokyo National Hospital

    Kiyose

  • Kobe City Medical Center General Hospital

    Kobe

  • Kobe Minimally Invasive Cancer Center

    Kobe

  • Kobe University Hospital

    Kobe

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Kōtoku

  • Kurashiki Central Hospital

    Kurashiki

  • National Hospital Organization Kure Medical Center and Chugoku Cancer

    Kure

  • Kurume University Hospital

    Kurume

  • Kyoto City Hospital

    Kyoto

  • Kyoto University Hospital

    Kyoto

  • Kyoto-Katsura Hospital

    Kyoto

  • National Hospital Organization Kyoto Medical Center

    Kyoto

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto

  • Shinshu University Hospital

    Matsumoto

  • Matsusaka Municipal Hospital

    Matsusaka

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku

  • The Jikei University Hospital

    Minatoku

  • Tokyo Saiseikai Central Hospital

    Minatoku

  • Kyorin University Hospital

    Mitaka

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki

  • Nagahama City Hospital

    Nagahama

  • Aichi Medical University Hospital

    Nagakute

  • Nagasaki University Hospital

    Nagasaki

  • Aichi Cancer Center

    Nagoya

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya

  • Nagoya City University Hospital

    Nagoya

  • Nagoya Ekisaikai 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

  • Ogaki Municipal Hospital

    Ōgaki

  • Oita Prefectural Hospital

    Ōita

  • 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

  • Osaka Saiseikai Nakatsu Hospital

    Osaka

  • Kindai University Hospital

    Ōsaka-sayama

  • Osaki Citizen Hospital

    Ōsaki

  • Gunma Prefectural Cancer Center

    Ōta-ku

  • Shiga University of Medical Science Hospital

    Ōtsu

  • Saga University Hospital

    Saga

  • Kitasato University Hospital

    Sagamihara

  • Jichi Medical University Saitama Medical Center

    Saitama

  • 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

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo

  • Sapporo Medical University Hospital

    Sapporo

  • Teine Keijinkai Hospital

    Sapporo

  • Sendai Kousei Hospital

    Sendai

  • Tohoku Medical And Pharmaceutical University Hospital

    Sendai

  • Tohoku University Hospital

    Sendai

  • Japanese Red Cross Medical Center

    Shibuya-Ku

  • Jichi Medical University Hospital

    Shimotsuke

  • Showa University Hospital

    Shinagawa-Ku

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-Ku

  • Keio University Hospital

    Shinjuku-Ku

  • Tokyo Medical University Hospital

    Shinjuku-Ku

  • Iwate Medical University Hospital

    Shiwa-gun

  • Shizuoka Cancer Center

    Shizuoka

  • Shizuoka General Hospital

    Shizuoka

  • Osaka University Hospital

    Suita

  • Saiseikai Suita Hospital

    Suita

  • Teikyo University Hospital

    tabashi City

  • 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

  • Ehime University Hospital

    Tōon

  • Toyama Prefectural Central Hospital

    Toyama

  • Fujita Health University Hospital

    Toyoake

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka

  • TOYOTA Memorial Hospital

    Toyota

  • Tsukuba Medical Center Hospital

    Tsukuba

  • University of Tsukuba Hospital

    Tsukuba

  • National Hospital Organization Yamaguchi-Ube Medical Center

    Ube

  • Juntendo University Urayasu Hospital

    Urayasu

  • Japanese Red Cross Wakayama Medical Center

    Wakayama

  • Wakayama Medical University Hospital

    Wakayama

  • Kanagawa Cancer Center

    Yokohama

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama

  • Yokohama City University Hospital

    Yokohama

  • Yokohama Municipal Citizen's Hospital

    Yokohama

  • Yokosuka Kyosai Hospital

    Yokosuka

  • Tottori University Hospital

    Yonago

  • Oita University Hospital

    Yufu

Other trials in Japan

About this study

Official title: 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

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.

Read the detailed description

Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)

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 groups in NCT04501497
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12 months survival rate

    Percentage of participants alive 12 months after initiation of treatment

    Measured: Baseline up to 12 Months

Secondary outcomes (11)

  1. Overall Survival

    OS was defined as the time from the first day of study treatment to death due to any cause

    Measured: Up to death (up to 3 years)

  2. 6 moths survival rate

    Percentage of participants alive 6 months after initiation of treatment

    Measured: Up to 6 months

  3. 18 moths survival rate

    Percentage of participants alive 18 months after initiation of treatment

    Measured: Up to 18 months

  4. Progression-Free Survival(PFS)

    PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)

    Measured: Up to disease progression or death whichever occurs first (up to 3 years)

  5. Time to treatment failure (TTF)

    TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death

    Measured: Up to 3 years

  6. Post-treatment transfer rate

    Rate of patients who received drug therapy for primary disease after study treatment

    Measured: Up to post-treatment is started (up to 3 years)

  7. Objective Response Rate(ORR)

    Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1

    Measured: Up to disease progression or death whichever occurs first (up to 3 years)

  8. Duration of Response(DOR)

    Duration of Response as Assessed by the Investigator According to RECIST v1.1

    Measured: From date of first objective response up to disease progression or death whichever occurs first (up to 3 years)

  9. Disease Control Rate(DCR)

    Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1

    Measured: Up to 3 years

  10. Percentage of Participants with adverse events(Adverse Reactions)

    The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0

    Measured: Up to 3 years

  11. Comprehensive geriatric assessment (G8)

    The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start21 Aug 2020
  3. Primary completion3 Feb 2023
  4. Study completion3 Feb 2023

Resources

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
1,221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501497
Sponsor's protocol ID
J-TAIL-2
Status last verified
Apr 2024
First submitted
2 Aug 2020
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

  • Shimizu J, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Goto Y, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Yoshimori K, Shibata K, Tsuda T, Seike M, Ota T, Samata K, Kobayashi Y, Tanaka M, Gemma A. Atezolizumab + Chemotherapy in Older Patients With Lung Cancer in Japan. Cancer Sci. 2026 Jul;117(7):1935-1947. doi: 10.1111/cas.70411. Epub 2026 May 14.

    PubMed 42135591

  • 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

  • Shirasawa M, Nishio M, Ohashi K, Osoegawa A, Kikuchi E, Kimura H, Goto Y, Shimizu J, Miyauchi E, Yoshioka H, Yoshino I, Misumi T, Yatabe Y, Yoshida T, Kashima J, Oki M, Ashimura H, Kobayashi Y, Tanaka M, Gemma A. Potential Immune Microenvironment Biomarkers in SCLC: J-TAIL-2 Observational Study. JTO Clin Res Rep. 2025 Oct 29;7(3):100926. doi: 10.1016/j.jtocrr.2025.100926. eCollection 2026 Mar.

    PubMed 41783745

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 148 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 10 inclusion and 3 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 148 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?

12 months survival rate (time frame: Baseline up to 12 Months). 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 NCT04501497, which also lists 3 linked publications.

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.

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