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

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 - 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-UMIN000041263

Enrollment

1200

Registered

2020-08-01

Start date

2020-08-17

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 and extensive disease small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: < 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 Use Promotion 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 Use Promotion 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.

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
12 month-survival rate	—

Secondary

Measure	Time frame
(1) Overall Survival: OS (2) 6 month-survival rate (3) Progression free survival: PFS (4) PFS rate (at 6,12 months) (5) Time to Treatment Failure: TTF (6) TTF rate (at 6,12 months) (7) Post-treatment transfer rate (8) Overall Response Rate: ORR (9) Duration of Response: DOR (10) Disease Control Rate: DCR (11) Incidence rate of Adverse Events (12) Comprehensive geriatric assessment(G8) (13) Analysis of immune-related adverse events (irAE) (14) Efficacy/safety by subpopulation or baseline factor characteristics Exploratory Endpoints (1) Survival rate (at 18,24 months) (2) PFS rate (at 18,24 months) (3) TTF rate (at 18,24 months)	—

Measure

Time frame

(1) Overall Survival: OS (2) 6 month-survival rate (3) Progression free survival: PFS (4) PFS rate (at 6,12 months) (5) Time to Treatment Failure: TTF (6) TTF rate (at 6,12 months) (7) Post-treatment transfer rate (8) Overall Response Rate: ORR (9) Duration of Response: DOR (10) Disease Control Rate: DCR (11) Incidence rate of Adverse Events (12) Comprehensive geriatric assessment(G8) (13) Analysis of immune-related adverse events (irAE) (14) Efficacy/safety by subpopulation or baseline factor characteristics Exploratory Endpoints (1) Survival rate (at 18,24 months) (2) PFS rate (at 18,24 months) (3) TTF rate (at 18,24 months)

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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