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

Completed

• Conditions: Non-small Cell Lung Cancer; Extensive Disease Small Cell Lung Cancer

• Registration Number: NCT04818983
• Lead Sponsor: Chugai Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Study Start: 2021-04-07
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Correlation between PD-L1 SNP and atezolizumab combination therapy	Baseline
Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy	Baseline

Trial Locations

Locations (95)

Hyogo Cancer Center; 🇯🇵 Akashi, Japan

Nippon Medical School Hospital; 🇯🇵 Bunkyō-Ku, Japan

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Japan

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka, Japan

Fukushima Medical University Hospital; 🇯🇵 Fukushima, Japan

Aso Iizuka Hospital; 🇯🇵 Iizuka, Japan

Teikyo University Hospital; 🇯🇵 Itabashi-Ku, Japan

Hospital of the University of Occupational and Envioronmental Health; 🇯🇵 Kitakyushu, Japan

Japan Anti-Tuberculosis Association Fukujuji Hospital; 🇯🇵 Kiyose, Japan

Kobe Minimally Invasive Cancer Center; 🇯🇵 Kobe, Japan

National Hospital Organization Tokyo Medical Center; 🇯🇵 Meguro-Ku, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Japan

Sendai Kousei Hospital; 🇯🇵 Sendai, Japan

Chiba University Hospital; 🇯🇵 Chiba, Japan

Kansai Medical University Hospital; 🇯🇵 Hirakata, Japan

Shimane University Hospital; 🇯🇵 Izumo, Japan

Kasukabe Medical Center; 🇯🇵 Kasukabe, Japan

Kitakyushu Municipal Medical Center; 🇯🇵 Kitakyushu, Japan

The Jikei University Hospital; 🇯🇵 Minato-Ku, Japan

National Hospital Organization Asahikawa Medical Center; 🇯🇵 Asahikawa, Japan

Tokyo Medical And Dental University, Medical Hospital; 🇯🇵 Bunkyō-Ku, Japan

Tokai University Hospital; 🇯🇵 Isehara, Japan

Itami City Hospital; 🇯🇵 Itami, Japan

National Hospital Organization Iwakuni Clinical Center; 🇯🇵 Iwakuni, Japan

Kanazawa University Hospital; 🇯🇵 Kanazawa, Japan

Kobe University Hospital; 🇯🇵 Kobe, Japan

The Cancer Institute Hospital of Japanese Foundation For Cancer Research; 🇯🇵 Koto-Ku, Japan

Kyoto City Hospital; 🇯🇵 Kyoto, Japan

Aichi Medical University Hospital; 🇯🇵 Nagakute, Japan

Nippon Medical School Chiba Hokusoh Hospital; 🇯🇵 Inzai, Japan

Asahikawa Medical University Hospital; 🇯🇵 Asahikawa, Japan

Juntendo University Hospital; 🇯🇵 Bunkyō-Ku, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka, Japan

National Hospital Organization Kyushu Medical Center; 🇯🇵 Fukuoka, Japan

National Hospital Organization Okinawa National Hospital; 🇯🇵 Ginowan, Japan

National Hospital Organization Himeji Medical Center; 🇯🇵 Himeji, Japan

Hiroshima University Hospital; 🇯🇵 Hiroshima, Japan

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

University Hospital, Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Aichi Cancer Center; 🇯🇵 Nagoya, Japan

Hirosaki University Hospital; 🇯🇵 Hirosaki, Japan

Kagawa University Hospital; 🇯🇵 Kagawa, Japan

Kagoshima University Hospital; 🇯🇵 Kagoshima, Japan

Kurume University Hospital; 🇯🇵 Kurume, Japan

Shinshu University Hospital; 🇯🇵 Matsumoto, Japan

Matsusaka Municipal Hospital; 🇯🇵 Matsusaka, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Japan

National Hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya, Japan

The Hospital of Hyogo College of Medicine; 🇯🇵 Nishinomiya, Japan

Obihiro Kosei Hospital; 🇯🇵 Obihiro, Japan

Teine Keijinkai Hospital; 🇯🇵 Sapporo, Japan

Tohoku University Hospital; 🇯🇵 Sendai, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Japan

Takarazuka City Hospital; 🇯🇵 Takarazuka, Japan

Dokkyo Medical University Hospital; 🇯🇵 Tochigi, Japan

National Hospital Organization Yamaguchi-Ube Medical Center; 🇯🇵 Ube, Japan

Miyazaki Prefectural Miyazaki Hospital; 🇯🇵 Miyazaki, Japan

Nagasaki University Hospital; 🇯🇵 Nagasaki, Japan

Kawasaki Medical School General Medical Center; 🇯🇵 Okayama, Japan

Okayama Rosai Hospital; 🇯🇵 Okayama, Japan

Osaka City General Hospital; 🇯🇵 Osaka, Japan

Osaka General Medical Center; 🇯🇵 Osaka, Japan

Saitama medical university International medical Center; 🇯🇵 Saitama, Japan

Kagawa Prefectural Central Hospital; 🇯🇵 Takamatsu, Japan

Wakayama Medical University Hospital; 🇯🇵 Wakayama, Japan

Nagoya City University Hospital; 🇯🇵 Nagoya, Japan

Niigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

Niigata University Medical and Dental Hospital; 🇯🇵 Niigata, Japan

Miyagi Cancer Center; 🇯🇵 Natori, Japan

Japanese Red Cross Okayama Hospital; 🇯🇵 Okayama, Japan

Osaka International Cancer Institute; 🇯🇵 Osaka, Japan

Saitama Prefectural Cancer Center; 🇯🇵 Saitama, Japan

National Hospital Organization Kinki-Chuo Chest Medical Center; 🇯🇵 Sakai, Japan

Showa University Hospital; 🇯🇵 Shinagawa-Ku, Japan

JA Toyama Kouseiren Takaoka Hospital; 🇯🇵 Takaoka, Japan

Tenri Hospital; 🇯🇵 Tenri, Japan

Tokushima University Hospital; 🇯🇵 Tokushima, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama, Japan

Shiga University of Medical Science Hospital; 🇯🇵 Ōtsu, Japan

Okayama University Hospital; 🇯🇵 Okayama, Japan

Saitama Red Cross Hospital; 🇯🇵 Saitama, Japan

Center Hospital of the National Center for Global Health and Medicine; 🇯🇵 Shinjuku-Ku, Japan

Iwate Medical University Hospital; 🇯🇵 Shiwa-gun, Japan

Osaka University Hospital; 🇯🇵 Suita, Japan

Saiseikai Suita Hospital; 🇯🇵 Suita, Japan

Osaka Medical and Pharmaceutical University Hospital; 🇯🇵 Takatsuki, Japan

Tohoku Medical And Pharmaceutical University Hospital; 🇯🇵 Sendai, Japan

Toyama Prefectural Central Hospital; 🇯🇵 Toyama, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Japan

Kanagawa Cardiovascular and Respiratory Center; 🇯🇵 Yokohama, Japan

Tottori University Hospital; 🇯🇵 Yonago, Japan

Kindai University Hospital; 🇯🇵 Ōsaka-sayama, Japan

Tokushima Prefectural Central Hospital; 🇯🇵 Tokushima, Japan

Oita University Hospital; 🇯🇵 Yufu, Japan

Gunma Prefectural Cancer Center; 🇯🇵 Ōta, Japan