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)

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) - The biomarker exploratory study in prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043663

Enrollment

450

Registered

2021-03-18

Start date

2021-03-22

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Non-small cell lung cancer or extensive disease small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the correlation of PD-L1 SNPs, protein expression levels in plasma, and an immune microenvironment of small cell lung cancer with efficacy and safety of atezolizumab combination therapy.	—

Countries

Japan

Contacts

Public ContactJun OKADA

EPS Corporation Clinical Research Center Real World Evidence Business Headquarters

prj-jtail2@eps.co.jp03-5804-5045

Outcome results