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

April 1, 2024 updated by: Chugai Pharmaceutical

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
12 months survival rate
Time Frame: Baseline up to 12 Months
Percentage of participants alive 12 months after initiation of treatment
Baseline up to 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to death (up to 3 years)
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
Time Frame: Up to 6 months
Percentage of participants alive 6 months after initiation of treatment
Up to 6 months
18 moths survival rate
Time Frame: Up to 18 months
Percentage of participants alive 18 months after initiation of treatment
Up to 18 months
Progression-Free Survival(PFS)
Time Frame: Up to disease progression or death whichever occurs first (up to 3 years)
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)
Time Frame: Up to 3 years
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
Time Frame: Up to post-treatment is started (up to 3 years)
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)
Time Frame: Up to disease progression or death whichever occurs first (up to 3 years)
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)
Time Frame: From date of first objective response up to disease progression or death whichever occurs first (up to 3 years)
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)
Time Frame: Up to 3 years
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)
Time Frame: Up to 3 years
The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0
Up to 3 years
Comprehensive geriatric assessment (G8)
Time Frame: At baseline
The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chugai Pharmaceutical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Japan Lung Cancer Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Akihiko GENMA, Nippon Medical School Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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