Clinical trial NCT04818983: The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Extensive Disease Small Cell Lung Cancer
Keywords: Atezolizumab
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Japan Lung Cancer Society
First posted: 2021-03-26
Enrollment: 470
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 treatment with atezolizumab combination therapy.


Eligibility criteria: Inclusion Criteria:

Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.

\<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 Clinical Use 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 Clinical Use 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. 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.

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.

Primary outcomes:
measure: Correlation between PD-L1 SNP and atezolizumab combination therapy
timeFrame: Baseline
measure: Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy
timeFrame: 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)
measure: Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Akashi
country: Japan
facility: Hyogo Cancer Center
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
city: Bunkyō-Ku
country: Japan
facility: Juntendo University Hospital
city: Bunkyō-Ku
country: Japan
facility: Nippon Medical School Hospital
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical And Dental University, Medical Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Ginowan
country: Japan
facility: National Hospital Organization Okinawa National Hospital
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Itabashi-Ku
country: Japan
facility: Teikyo University Hospital
city: Itami
country: Japan
facility: Itami City Hospital
city: Iwakuni
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
city: Izumo
country: Japan
facility: Shimane University Hospital
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kasukabe
country: Japan
facility: Kasukabe Medical Center
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Envioronmental Health
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center
city: Kiyose
country: Japan
facility: Japan Anti-Tuberculosis Association Fukujuji Hospital
city: Kobe
country: Japan
facility: Kobe Minimally Invasive Cancer Center
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: Kyoto City Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital
city: Meguro-Ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Natori
country: Japan
facility: Miyagi Cancer Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Obihiro
country: Japan
facility: Obihiro Kosei Hospital
city: Okayama
country: Japan
facility: Japanese Red Cross Okayama Hospital
city: Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center
city: Okayama
country: Japan
facility: Okayama Rosai Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama medical university International medical Center
city: Saitama
country: Japan
facility: Saitama Prefectural Cancer Center
city: Saitama
country: Japan
facility: Saitama Red Cross Hospital
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
city: Sendai
country: Japan
facility: Tohoku Medical And Pharmaceutical University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shinagawa-Ku
country: Japan
facility: Showa University Hospital
city: Shinjuku-Ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Takaoka
country: Japan
facility: JA Toyama Kouseiren Takaoka Hospital
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Tenri
country: Japan
facility: Tenri Hospital
city: Tochigi
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Ube
country: Japan
facility: National Hospital Organization Yamaguchi-Ube Medical Center
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Yonago
country: Japan
facility: Tottori University Hospital
city: Yufu
country: Japan
facility: Oita University Hospital
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
city: Ōta
country: Japan
facility: Gunma Prefectural Cancer Center
city: Ōtsu
country: Japan
facility: Shiga University of Medical Science Hospital
Study officials:
affiliation: Nippon Medical School
name: Akihiko GENMA
role: PRINCIPAL_INVESTIGATOR
References: