Status:

COMPLETED

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

Lead Sponsor:

Chugai Pharmaceutical

Collaborating Sponsors:

Japan Lung Cancer Society

Conditions:

Non-small Cell Lung Cancer

Extensive Disease Small Cell Lung Cancer

Eligibility:

All Genders

20+ years

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...

Eligibility Criteria

Inclusion

  • Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.
  • \<non-small cell lung cancer cohort\>
  • Patients 20 years of age or older at the time of signed consent.
  • Patients with unresectable, advanced and recurrent non-small cell lung cancer.
  • Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
  • 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\>
  • Patients 20 years of age or older at the time of signed consent.
  • Patients with extensive disease small cell lung cancer.
  • Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
  • 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

  • \<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.

Key Trial Info

Start Date :

April 7 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 3 2023

Estimated Enrollment :

470 Patients enrolled

Trial Details

Trial ID

NCT04818983

Start Date

April 7 2021

End Date

February 3 2023

Last Update

April 2 2024

Active Locations (95)

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Page 1 of 24 (95 locations)

1

Hyogo Cancer Center

Akashi, Japan

2

Asahikawa Medical University Hospital

Asahikawa, Japan

3

National Hospital Organization Asahikawa Medical Center

Asahikawa, Japan

4

Juntendo University Hospital

Bunkyō City, Japan