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NCT Number: NCT04818983

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Extensive Disease Small Cell Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hyogo Cancer Center, Akashi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

<non-small cell lung cancer cohort>

  • Patients who are unsuitable for enrolment into the study by the investigator's judgment.

<extensive disease small cell lung cancer cohort>

  • Patients who are unsuitable for enrolment into the study by the investigator's judgment.

Treatment and study plan

Primary outcomes

  1. Correlation between PD-L1 SNP and atezolizumab combination therapy

    Time frame: Baseline

  2. Correlation between rate of change in plasma protein expression level and atezolizumab combination therapy

    Time frame: 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)

  3. Correlation between an immune microenvironment of small cell lung cancer and atezolizumab combination therapy

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Collaborators

  • Japan Lung Cancer Society

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2021
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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