Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
- Conditions
- Non-small Cell Lung CancerExtensive Disease Small Cell Lung Cancer
- Registration Number
- NCT04501497
- Lead Sponsor
- Chugai Pharmaceutical
- Brief 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). 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1221
< 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>
- 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.
< 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12 months survival rate Baseline up to 12 Months Percentage of participants alive 12 months after initiation of treatment
- Secondary Outcome Measures
Name Time Method Overall Survival Up to death (up to 3 years) OS was defined as the time from the first day of study treatment to death due to any cause
6 moths survival rate Up to 6 months Percentage of participants alive 6 months after initiation of treatment
18 moths survival rate Up to 18 months Percentage of participants alive 18 months after initiation of treatment
Progression-Free Survival(PFS) Up to disease progression or death whichever occurs first (up to 3 years) 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)
Time to treatment failure (TTF) Up to 3 years 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
Post-treatment transfer rate Up to post-treatment is started (up to 3 years) Rate of patients who received drug therapy for primary disease after study treatment
Objective Response Rate(ORR) Up to disease progression or death whichever occurs first (up to 3 years) Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
Duration of Response(DOR) From date of first objective response up to disease progression or death whichever occurs first (up to 3 years) Duration of Response as Assessed by the Investigator According to RECIST v1.1
Disease Control Rate(DCR) Up to 3 years Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
Percentage of Participants with adverse events(Adverse Reactions) Up to 3 years The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0
Comprehensive geriatric assessment (G8) At baseline The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment
Trial Locations
- Locations (148)
Akashi Medical Center
🇯🇵Akashi, Japan
National Hospital Organization Asahikawa Medical Center
🇯🇵Asahikawa, Japan
Nippon Medical School Hospital
🇯🇵Bunkyō-Ku, Japan
Juntendo University Hospital
🇯🇵Bunkyō-Ku, Japan
Hyogo Cancer Center
🇯🇵Akashi, Japan
Tokyo Medical And Dental University, Medical Hospital
🇯🇵Bunkyō-Ku, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Fujisawa City Hospital
🇯🇵Fujisawa, Japan
National Cancer Center Hospital
🇯🇵Chuo Ku, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Japan
Japanese Red Cross Ise Hospital
🇯🇵Ise, Japan
Itami City Hospital
🇯🇵Itami, Japan
Juntendo University Shizuoka Hospital
🇯🇵Izunokuni, 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
Japan Anti-Tuberculosis Association Fukujuji Hospital
🇯🇵Kiyose, Japan
National Hospital Organization Tokyo National Hospital
🇯🇵Kiyose, Japan
Kishiwada City Hospital
🇯🇵Kishiwada, Japan
Japan Community Health care Organization Kyushu Hospital
🇯🇵Kitakyushu, Japan
Hospital of the University of Occupational and Envioronmental Health
🇯🇵Kitakyushu, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Japan
Dokkyo Medical University Saitama Medical Center
🇯🇵Koshigaya, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
🇯🇵Koto-Ku, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer
🇯🇵Kure, Japan
Kobe University Hospital
🇯🇵Kobe, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Japan
Kurume University Hospital
🇯🇵Kurume, Japan
Kyoto City Hospital
🇯🇵Kyoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Kyoto-Katsura Hospital
🇯🇵Kyoto, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-Ku, Japan
The Jikei University Hospital
🇯🇵Minato-Ku, Japan
Miyazaki Prefectural Miyazaki Hospital
🇯🇵Miyazaki, Japan
Nagahama City Hospital
🇯🇵Nagahama, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Japan
Nagoya Ekisaikai Hospital
🇯🇵Nagoya, Japan
Miyagi Cancer Center
🇯🇵Natori, Japan
The Hospital of Hyogo College of Medicine
🇯🇵Nishinomiya, Japan
Saga University Hospital
🇯🇵Saga, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Sakai, Japan
Japanese Red Cross Okayama Hospital
🇯🇵Okayama, Japan
Okayama Rosai Hospital
🇯🇵Okayama, Japan
Osaka Saiseikai Nakatsu Hospital
🇯🇵Osaka, Japan
Osaka City General Hospital
🇯🇵Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Osaki Citizen Hospital
🇯🇵Osaki, Japan
Jichi Medical University Saitama Medical Center
🇯🇵Saitama, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Saitama Prefectural Cancer Center
🇯🇵Saitama, Japan
Saitama Red Cross Hospital
🇯🇵Saitama, Japan
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Shinjuku-Ku, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Japan
Tohoku Medical And Pharmaceutical University Hospital
🇯🇵Sendai, Japan
Saiseikai Suita Hospital
🇯🇵Suita, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki, Japan
Tenri Hospital
🇯🇵Tenri, Japan
Tsukuba Medical Center Hospital
🇯🇵Tsukuba, Japan
Fujita Health University Hospital
🇯🇵Toyoake, Japan
National Hospital Organization Osaka Toneyama Medical Center
🇯🇵Toyonaka, Japan
TOYOTA Memorial Hospital
🇯🇵Toyota, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Japan
National Hospital Organization Yamaguchi-Ube Medical Center
🇯🇵Ube, Japan
Japanese Red Cross Wakayama Medical Center
🇯🇵Wakayama, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Japan
Yokosuka Kyosai Hospital
🇯🇵Yokosuka, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Japan
Ogaki Municipal Hospital
🇯🇵Ōgaki, Japan
Tottori University Hospital
🇯🇵Yonago, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Japan
Oita University Hospital
🇯🇵Yufu, Japan
Gunma Prefectural Cancer Center
🇯🇵Ōta, Japan
Shiga University of Medical Science Hospital
🇯🇵Ōtsu, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Kagawa University Hospital
🇯🇵Kagawa, Japan
Gifu Prefectural General Medical Center
🇯🇵Gifu, Japan
National Hospital Organization Okinawa National Hospital
🇯🇵Ginowan, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Himeji, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Aso Iizuka Hospital
🇯🇵Iizuka, Japan
National Hospital Organization Iwakuni Clinical Center
🇯🇵Iwakuni, Japan
Teikyo University Hospital
🇯🇵Itabashi-Ku, Japan
Shimane University Hospital
🇯🇵Izumo, Japan
Tokai University Hospital
🇯🇵Isehara, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Kitakyushu Municipal Medical Center
🇯🇵Kitakyushu, Japan
Matsusaka Municipal Hospital
🇯🇵Matsusaka, Japan
National Hospital Organization Kyoto Medical Center
🇯🇵Kyoto, Japan
Tokyo Saiseikai Central Hospital
🇯🇵Minato-Ku, Japan
Aichi Cancer Center
🇯🇵Nagoya, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Nagoya, Japan
Nagoya University Hospital
🇯🇵Nagoya, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Obihiro Kosei Hospital
🇯🇵Obihiro, Japan
Kawasaki Medical School General Medical Center
🇯🇵Okayama, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Kitasato University Hospital
🇯🇵Sagamihara, Japan
Saitama medical university International medical Center
🇯🇵Saitama, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Japan
Teine Keijinkai Hospital
🇯🇵Sapporo, Japan
Sendai Kousei Hospital
🇯🇵Sendai, Japan
Showa University Hospital
🇯🇵Shinagawa-Ku, Japan
Iwate Medical University Hospital
🇯🇵Shiwa-gun, Japan
Osaka University Hospital
🇯🇵Suita, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
Oita Prefectural Hospital
🇯🇵Ōita, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
Nippon Medical School Chiba Hokusoh Hospital
🇯🇵Inzai, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Kobe Minimally Invasive Cancer Center
🇯🇵Kobe, Japan
Kyorin University Hospital
🇯🇵Mitaka, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
Dokkyo Medical University Hospital
🇯🇵Tochigi, Japan
Japanese Red Cross Medical Center
🇯🇵Shibuya-Ku, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-Ku, Japan
JA Toyama Kouseiren Takaoka Hospital
🇯🇵Takaoka, Japan
Shizuoka General Hospital
🇯🇵Shizuoka, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Japan
Takarazuka City Hospital
🇯🇵Takarazuka, Japan
Tokushima Prefectural Central Hospital
🇯🇵Tokushima, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Japan
Ehime University Hospital
🇯🇵Tōon, Japan
Kindai University Hospital
🇯🇵Ōsaka-sayama, Japan
Yokohama Municipal Citizen's Hospital
🇯🇵Yokohama, Japan