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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04501497
• Other study ID #: J-TAIL-2
• Status: Completed
• Start date: August 21, 2020
• Est. completion date: February 3, 2023

Study information

• Verified date: April 2024
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1221
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion 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 Use Promotion 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 Use Promotion 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.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Extensive Disease Small Cell Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
Japan	Akashi Medical Center	Akashi
Japan	Hyogo Cancer Center	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	Bunkyo-Ku
Japan	Nippon Medical School Hospital	Bunkyo-Ku
Japan	Tokyo Medical And Dental University, Medical Hospital	Bunkyo-Ku
Japan	Chiba University Hospital	Chiba
Japan	National Cancer Center Hospital	Chuo Ku
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	Koto-Ku
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	Minato-Ku
Japan	Tokyo Saiseikai Central Hospital	Minato-Ku
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	Ogaki Municipal Hospital	Ogaki
Japan	Oita Prefectural Hospital	Oita
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	Kindai University Hospital	Osaka-sayama
Japan	Osaki Citizen Hospital	Osaki
Japan	Gunma Prefectural Cancer Center	Ota
Japan	Shiga University of Medical Science Hospital	Otsu
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	Ehime University Hospital	Toon
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	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

Sponsors (2)

Lead Sponsor	Collaborator
Chugai Pharmaceutical	Japan Lung Cancer Society

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 months survival rate	Percentage of participants alive 12 months after initiation of treatment	Baseline up to 12 Months
Secondary	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)
Secondary	6 moths survival rate	Percentage of participants alive 6 months after initiation of treatment	Up to 6 months
Secondary	18 moths survival rate	Percentage of participants alive 18 months after initiation of treatment	Up to 18 months
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Disease Control Rate(DCR)	Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1	Up to 3 years
Secondary	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
Secondary	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