A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)

Study Overview
=================
Brief Summary
-----------------
This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

Detailed Description
-----------------
Primary endpoint: 18 months OS, Secondary endpoints: Overall Survival(OS), 12 months survival rate(12mo OS), 24 months survival rate(24mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Official Title
-----------------
Prospective Multicenter Observational Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic Non-small Cell Lung Cancer: (J-TAIL)

Conditions
-----------------
Non-small-Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 20 years of age or older at the time of signed consent. Patients with locally advanced or metastatic non-small cell lung cancer. Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion 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. Exclusion Criteria: Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18 months survival rate | Percentage of participants alive 18 months after initiation of treatment | Baseline up to 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | OS was defined as the time from the first day of study treatment to death due to any cause | Up to death (up to 4 years) | 
| 12 months survival rate | Percentage of participants alive 12 months after initiation of treatment | Up to 12 months | 
| 24 months survival rate | Percentage of participants alive 24 months after initiation of treatment | Up to 24 months | 
| Progression-Free Survival(PFS) | PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1) | Up to disease progression or death whichever occurs first (up to 4 years) | 
| Time to treatment failure (TTF) | TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death | Up to 4 years | 
| Objective Response Rate(ORR) | Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1 | Up to disease progression or death whichever occurs first (up to 4 years) | 
| Disease Control Rate(DCR) | Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1 | Up to 4 years | 
| Duration of Response(DOR) | Duration of Response as Assessed by the Investigator According to RECIST v1.1 | From date of first objective response up to disease progression or death whichever occurs first (up to 4 years) | 
| Percentage of Participants with adverse events(Adverse Reactions) | The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v4.0 | Up to 4 years | 
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire | EQ-5D-5L consists of five standardized questions. Evaluate the quality of life by converting the result obtained into scores (range: 1.000 to - 0.025). Higher values give better results. | Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years) | 

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