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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04818983

Enrollment

470

Registered

2021-03-26

Start date

2021-04-07

Completion date

2023-02-03

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Atezolizumab

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 cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion/

Exclusion criteria

of J-TAIL-2 study is to be applied. \<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 Clinical Use 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 Clinical Use 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. 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.

Design outcomes

Primary

Measure	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

Countries

Japan

Outcome results