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

Chugai Pharmaceutical

Status: Completed

Conditions: Non-small Cell Lung Cancer; Extensive Disease Small Cell Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04501497

J-TAIL-2

Details and patient eligibility

About

This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

Full description

Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)

Enrollment: 1,221 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

< 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.

Trial design

1,221 participants in 2 patient groups

NSCLC cohort (N=800)

Description:

Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care

ED-SCLC cohort (N=400)

Description:

Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care