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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Non-small Cell Lung Cancer, Extensive Disease Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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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> 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC cohort<br>Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care | |
| ED-SCLC cohort<br>Patients with extensive disease small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between PD-L1 SNP and atezolizumab combination therapy |  | Baseline | 
| 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 an immune microenvironment of small cell lung cancer and atezolizumab combination therapy |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atezolizumab