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

Non-small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818983
• Other study ID #: J-TAIL-2 biomarkers
• Status: Completed
• Start date: April 7, 2021
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

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	Hyogo Cancer Center	Akashi
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	Fukuoka 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	National Hospital Organization Okinawa National Hospital	Ginowan
Japan	National Hospital Organization Himeji Medical Center	Himeji
Japan	Kansai Medical University Hospital	Hirakata
Japan	Hirosaki University Hospital	Hirosaki
Japan	Hiroshima University Hospital	Hiroshima
Japan	Aso Iizuka Hospital	Iizuka
Japan	Nippon Medical School Chiba Hokusoh Hospital	Inzai
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	Kagawa University Hospital	Kagawa
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kanazawa University Hospital	Kanazawa
Japan	Kasukabe Medical Center	Kasukabe
Japan	Hospital of the University of Occupational and Envioronmental Health	Kitakyushu
Japan	Kitakyushu Municipal Medical Center	Kitakyushu
Japan	Japan Anti-Tuberculosis Association Fukujuji Hospital	Kiyose
Japan	Kobe Minimally Invasive Cancer Center	Kobe
Japan	Kobe University Hospital	Kobe
Japan	The Cancer Institute Hospital of Japanese Foundation For Cancer Research	Koto-Ku
Japan	Kurume University Hospital	Kurume
Japan	Kyoto City Hospital	Kyoto
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	Shinshu University Hospital	Matsumoto
Japan	Matsusaka Municipal Hospital	Matsusaka
Japan	National Hospital Organization Tokyo Medical Center	Meguro-Ku
Japan	The Jikei University Hospital	Minato-Ku
Japan	Miyazaki Prefectural Miyazaki Hospital	Miyazaki
Japan	Aichi Medical University Hospital	Nagakute
Japan	Nagasaki University Hospital	Nagasaki
Japan	Aichi Cancer Center	Nagoya
Japan	Nagoya City University 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	Kindai University Hospital	Osaka-sayama
Japan	Gunma Prefectural Cancer Center	Ota
Japan	Shiga University of Medical Science Hospital	Otsu
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	Teine Keijinkai Hospital	Sapporo
Japan	Sendai Kousei Hospital	Sendai
Japan	Tohoku Medical And Pharmaceutical University Hospital	Sendai
Japan	Tohoku University Hospital	Sendai
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	Iwate Medical University Hospital	Shiwa-gun
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 Yamaguchi-Ube Medical Center	Ube
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama
Japan	Yokohama City University Hospital	Yokohama
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	Correlation between PD-L1 SNP and atezolizumab combination therapy		Baseline
Primary	Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy		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)
Primary	Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy		Baseline