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| Name | Class |
|---|---|
| Japan Lung Cancer Society | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 12 months survival rate | Percentage of participants alive 12 months after initiation of treatment | Baseline up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS was defined as the time from the first day of study treatment to death due to any cause | Up to death (up to 3 years) |
| 6 moths survival rate | Percentage of participants alive 6 months after initiation of treatment |
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Inclusion Criteria:
< non-small cell lung cancer cohort>
<extensive disease small cell lung cancer cohort>
Exclusion Criteria:
< 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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Akihiko GENMA | Nippon Medical School Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akashi Medical Center | Akashi | Japan | ||||
| Hyogo Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42135591 | Derived | 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 May 14. doi: 10.1111/cas.70411. Online ahead of print. | |
| 42014371 |
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All IPD that underlie results in a publication
After the end of the study
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| Up to 6 months |
| 18 moths survival rate | Percentage of participants alive 18 months after initiation of treatment | Up to 18 months |
| 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) | Up to disease progression or death whichever occurs first (up to 3 years) |
| 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 | Up to 3 years |
| Post-treatment transfer rate | Rate of patients who received drug therapy for primary disease after study treatment | Up to post-treatment is started (up to 3 years) |
| Objective Response Rate(ORR) | Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1 | Up to disease progression or death whichever occurs first (up to 3 years) |
| Duration of Response(DOR) | Duration of Response as Assessed by the Investigator According to RECIST v1.1 | From date of first objective response up to disease progression or death whichever occurs first (up to 3 years) |
| Disease Control Rate(DCR) | Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1 | Up to 3 years |
| Percentage of Participants with adverse events(Adverse Reactions) | The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0 | Up to 3 years |
| Comprehensive geriatric assessment (G8) | The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment | At baseline |
| 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 |
| 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 Apr 21. doi: 10.1111/cas.70375. Online ahead of print. |
| 41783745 | Derived | 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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