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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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)

Official Title
-----------------
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

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < non-small cell lung cancer cohort> Patients 20 years of age or older at the time of signed consent. Patients with unresectable, advanced and recurrent non-small cell lung cancer. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, 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. <extensive disease small cell lung cancer cohort> Patients 20 years of age or older at the time of signed consent. Patients with extensive disease small cell lung cancer. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, 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: < 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.

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

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

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC cohort (N=800)<br>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)<br>Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 months survival rate | Percentage of participants alive 12 months after initiation of treatment | Baseline up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS was defined as the time from the first day of study treatment to death due to any cause | Up to death (up to 3 years) | 
| 6 moths survival rate | Percentage of participants alive 6 months after initiation of treatment | Up to 6 months | 
| 18 moths survival rate | Percentage of participants alive 18 months after initiation of treatment | Up to 18 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 3 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 3 years | 
| Post-treatment transfer rate | Rate of patients who received drug therapy for primary disease after study treatment | Up to post-treatment is started (up to 3 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 3 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 3 years) | 
| Disease Control Rate(DCR) | Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1 | Up to 3 years | 
| Percentage of Participants with adverse events(Adverse Reactions) | The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0 | Up to 3 years | 
| Comprehensive geriatric assessment (G8) | The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment | At baseline | 

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