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

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

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.

Study Overview

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

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)

• Study Type: Observational
• Enrollment (Actual): 1221

Contacts and Locations

• Study Contact: Name: J-TAIL-2 study exective office; Phone Number: +81-3-5804-5045; Email: prj-jtail2@eps.co.jp

Study Locations

• Japan
  • Akashi, Japan
    • Akashi Medical Center
  • Akashi, Japan
    • Hyogo Cancer Center
  • Amagasaki, Japan
    • Hyogo Prefectural Amagasaki General Medical Center
  • Asahikawa, Japan
    • Asahikawa Medical University Hospital
  • Asahikawa, Japan
    • National Hospital Organization Asahikawa Medical Center
  • Bunkyō-Ku, Japan
    • Juntendo University Hospital
  • Bunkyō-Ku, Japan
    • Nippon Medical School Hospital
  • Bunkyō-Ku, Japan
    • Tokyo Medical And Dental University, Medical Hospital
  • Chiba, Japan
    • Chiba University Hospital
  • Chuo Ku, Japan
    • National Cancer Center Hospital
  • Fujisawa, Japan
    • Fujisawa City Hospital
  • Fukui, Japan
    • Fukui Prefectural Hospital
  • Fukuoka, Japan
    • Fukuoka University Hospital
  • Fukuoka, Japan
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan
    • Kyushu University Hospital
  • Fukuoka, Japan
    • National Hospital Organization Kyushu Medical Center
  • Fukushima, Japan
    • Fukushima Medical University Hospital
  • Gifu, Japan
    • Gifu Prefectural General Medical Center
  • Ginowan, Japan
    • National Hospital Organization Okinawa National Hospital
  • Hamamatsu, Japan
    • Hamamatsu University Hospital
  • Himeji, Japan
    • National Hospital Organization Himeji Medical Center
  • Hirakata, Japan
    • Kansai Medical University Hospital
  • Hirosaki, Japan
    • Hirosaki University Hospital
  • Hiroshima, Japan
    • Hiroshima University Hospital
  • Hiroshima, Japan
    • Hiroshima Prefectural Hospital
  • Hiroshima, Japan
    • Hiroshima City Hiroshima Citizens Hospital
  • Iizuka, Japan
    • Aso Iizuka Hospital
  • Inzai, Japan
    • Nippon Medical School Chiba Hokusoh Hospital
  • Ise, Japan
    • Japanese Red Cross Ise Hospital
  • Isehara, Japan
    • Tokai University Hospital
  • Itabashi-Ku, Japan
    • Teikyo University Hospital
  • Itami, Japan
    • Itami City Hospital
  • Iwakuni, Japan
    • National Hospital Organization Iwakuni Clinical Center
  • Izumo, Japan
    • Shimane University Hospital
  • Izunokuni, Japan
    • Juntendo University Shizuoka Hospital
  • Kagawa, Japan
    • Kagawa University Hospital
  • Kagoshima, Japan
    • Kagoshima University Hospital
  • Kamogawa, Japan
    • Kameda Medical Center
  • Kanazawa, Japan
    • Ishikawa Prefectural Central Hospital
  • Kanazawa, Japan
    • Kanazawa University Hospital
  • Kasama, Japan
    • Ibaraki Prefectural Central Hospital
  • Kasukabe, Japan
    • Kasukabe Medical Center
  • Kishiwada, Japan
    • Kishiwada City Hospital
  • Kitakyushu, Japan
    • Japan Community Health care Organization Kyushu Hospital
  • Kitakyushu, Japan
    • Kitakyushu Municipal Medical Center
  • Kitakyushu, Japan
    • Hospital of the University of Occupational and Envioronmental Health
  • Kiyose, Japan
    • National Hospital Organization Tokyo National Hospital
  • Kiyose, Japan
    • Japan Anti-Tuberculosis Association Fukujuji Hospital
  • Kobe, Japan
    • Kobe City Medical Center General Hospital
  • Kobe, Japan
    • Kobe University Hospital
  • Kobe, Japan
    • Kobe Minimally Invasive Cancer Center
  • Koshigaya, Japan
    • Dokkyo Medical University Saitama Medical Center
  • Koto-Ku, Japan
    • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Kurashiki, Japan
    • Kurashiki Central Hospital
  • Kure, Japan
    • National Hospital Organization Kure Medical Center and Chugoku Cancer
  • Kurume, Japan
    • Kurume University Hospital
  • Kyoto, Japan
    • Kyoto University Hospital
  • Kyoto, Japan
    • University Hospital, Kyoto Prefectural University of Medicine
  • Kyoto, Japan
    • Kyoto-Katsura Hospital
  • Kyoto, Japan
    • Kyoto City Hospital
  • Kyoto, Japan
    • National Hospital Organization Kyoto Medical Center
  • Matsumoto, Japan
    • Shinshu University Hospital
  • Matsusaka, Japan
    • Matsusaka Municipal Hospital
  • Matsuyama, Japan
    • National Hospital Organization Shikoku Cancer Center
  • Meguro-Ku, Japan
    • National Hospital Organization Tokyo Medical Center
  • Minato-Ku, Japan
    • The Jikei University Hospital
  • Minato-Ku, Japan
    • Tokyo Saiseikai Central Hospital
  • Mitaka, Japan
    • Kyorin University Hospital
  • Miyazaki, Japan
    • Miyazaki Prefectural Miyazaki Hospital
  • Nagahama, Japan
    • Nagahama City Hospital
  • Nagakute, Japan
    • Aichi Medical University Hospital
  • Nagasaki, Japan
    • Nagasaki University Hospital
  • Nagoya, Japan
    • Nagoya University Hospital
  • Nagoya, Japan
    • Japanese Red Cross Nagoya Daini Hospital
  • Nagoya, Japan
    • Nagoya City University Hospital
  • Nagoya, Japan
    • Aichi Cancer Center
  • Nagoya, Japan
    • Nagoya Ekisaikai Hospital
  • Nagoya, Japan
    • National Hospital Organization Nagoya Medical Center
  • Natori, Japan
    • Miyagi Cancer Center
  • Niigata, Japan
    • Niigata Cancer Center Hospital
  • Niigata, Japan
    • Niigata University Medical And Dental Hospital
  • Nishinomiya, Japan
    • The Hospital of Hyogo College of Medicine
  • Obihiro, Japan
    • Obihiro Kosei Hospital
  • Okayama, Japan
    • Okayama University Hospital
  • Okayama, Japan
    • Japanese Red Cross Okayama Hospital
  • Okayama, Japan
    • Kawasaki Medical School General Medical Center
  • Okayama, Japan
    • Okayama Rosai Hospital
  • Osaka, Japan
    • Osaka City General Hospital
  • Osaka, Japan
    • Osaka International Cancer Institute
  • Osaka, Japan
    • Osaka General Medical Center
  • Osaka, Japan
    • Osaka Saiseikai Nakatsu Hospital
  • Osaki, Japan
    • Osaki Citizen Hospital
  • Saga, Japan
    • Saga University Hospital
  • Sagamihara, Japan
    • Kitasato University Hospital
  • Saitama, Japan
    • Jichi Medical University Saitama Medical Center
  • Saitama, Japan
    • Saitama Prefectural Cancer Center
  • Saitama, Japan
    • Saitama Medical University International Medical Center
  • Saitama, Japan
    • Saitama Red Cross Hospital
  • Sakai, Japan
    • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Sapporo, Japan
    • Hokkaido University Hospital
  • Sapporo, Japan
    • Teine Keijinkai Hospital
  • Sapporo, Japan
    • Sapporo Medical University Hospital
  • Sapporo, Japan
    • National Hospital Organization Hokkaido Cancer Center
  • Sendai, Japan
    • Tohoku University Hospital
  • Sendai, Japan
    • Sendai Kousei Hospital
  • Sendai, Japan
    • Tohoku Medical And Pharmaceutical University Hospital
  • Shibuya-Ku, Japan
    • Japanese Red Cross Medical Center
  • Shimotsuke, Japan
    • Jichi Medical University Hospital
  • Shinagawa-Ku, Japan
    • Showa University Hospital
  • Shinjuku-Ku, Japan
    • Keio University Hospital
  • Shinjuku-Ku, Japan
    • Tokyo Medical University Hospital
  • Shinjuku-Ku, Japan
    • Center Hospital of the National Center for Global Health and Medicine
  • Shiwa-gun, Japan
    • Iwate Medical University Hospital
  • Shizuoka, Japan
    • Shizuoka Cancer Center
  • Shizuoka, Japan
    • Shizuoka General Hospital
  • Suita, Japan
    • Osaka University Hospital
  • Suita, Japan
    • Saiseikai Suita Hospital
  • Takamatsu, Japan
    • Kagawa Prefectural Central Hospital
  • Takaoka, Japan
    • JA Toyama Kouseiren Takaoka Hospital
  • Takarazuka, Japan
    • Takarazuka City Hospital
  • Takatsuki, Japan
    • Osaka Medical and Pharmaceutical University Hospital
  • Tenri, Japan
    • Tenri Hospital
  • Tochigi, Japan
    • Dokkyo Medical University Hospital
  • Tokushima, Japan
    • Tokushima University Hospital
  • Tokushima, Japan
    • Tokushima Prefectural Central Hospital
  • Toyama, Japan
    • Toyama Prefectural Central Hospital
  • Toyoake, Japan
    • Fujita Health University Hospital
  • Toyonaka, Japan
    • National Hospital Organization Osaka Toneyama Medical Center
  • Toyota, Japan
    • Toyota Memorial Hospital
  • Tsukuba, Japan
    • University of Tsukuba Hospital
  • Tsukuba, Japan
    • Tsukuba Medical Center Hospital
  • Tōon, Japan
    • Ehime University Hospital
  • Ube, Japan
    • National Hospital Organization Yamaguchi-Ube Medical Center
  • Urayasu, Japan
    • Juntendo University Urayasu Hospital
  • Wakayama, Japan
    • Wakayama Medical University Hospital
  • Wakayama, Japan
    • Japanese Red Cross Wakayama Medical center
  • Yokohama, Japan
    • Yokohama City University Hospital
  • Yokohama, Japan
    • Kanagawa Cardiovascular And Respiratory Center
  • Yokohama, Japan
    • Yokohama Municipal Citizen's Hospital
  • Yokohama, Japan
    • Kanagawa Cancer Center
  • Yokosuka, Japan
    • Yokosuka Kyosai Hospital
  • Yonago, Japan
    • Tottori University Hospital
  • Yufu, Japan
    • Oita University Hospital
  • Ōgaki, Japan
    • Ogaki Municipal Hospital
  • Ōita, Japan
    • Oita Prefectural Hospital
  • Ōsaka-sayama, Japan
    • Kindai University Hospital
  • Ōta, Japan
    • Gunma Prefectural Cancer Center
  • Ōtsu, Japan
    • Shiga University of Medical Science Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NSCLC cohort (N=800); Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
ED-SCLC cohort (N=400); Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 months survival rate	Percentage of participants alive 12 months after initiation of treatment	Baseline up to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
6 moths survival rate	Percentage of participants alive 6 months after initiation of treatment	Up to 6 months
18 moths survival rate	Percentage of participants alive 18 months after initiation of treatment	Up to 18 months
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)
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
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)
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)
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)
Disease Control Rate(DCR)	Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1	Up to 3 years
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
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

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Collaborators: Japan Lung Cancer Society
• Investigators: Principal Investigator: Akihiko GENMA, Nippon Medical School Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Atezolizumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
• Other Study ID Numbers: J-TAIL-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: After the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No