Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)
- Conditions
- Non-small Cell Lung CancerExtensive Disease Small Cell Lung Cancer
- Registration Number
- NCT04501497
- Lead Sponsor
- Chugai Pharmaceutical
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1221
< 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.
< 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12 months survival rate Baseline up to 12 Months Percentage of participants alive 12 months after initiation of treatment
- Secondary Outcome Measures
Name Time Method Overall Survival Up to death (up to 3 years) OS was defined as the time from the first day of study treatment to death due to any cause
6 moths survival rate Up to 6 months Percentage of participants alive 6 months after initiation of treatment
18 moths survival rate Up to 18 months Percentage of participants alive 18 months after initiation of treatment
Progression-Free Survival(PFS) Up to disease progression or death whichever occurs first (up to 3 years) 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)
Time to treatment failure (TTF) Up to 3 years 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
Post-treatment transfer rate Up to post-treatment is started (up to 3 years) Rate of patients who received drug therapy for primary disease after study treatment
Objective Response Rate(ORR) Up to disease progression or death whichever occurs first (up to 3 years) Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
Duration of Response(DOR) From date of first objective response up to disease progression or death whichever occurs first (up to 3 years) Duration of Response as Assessed by the Investigator According to RECIST v1.1
Disease Control Rate(DCR) Up to 3 years Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
Percentage of Participants with adverse events(Adverse Reactions) Up to 3 years The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0
Comprehensive geriatric assessment (G8) At baseline The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment
Trial Locations
- Locations (148)
Akashi Medical Center
🇯🇵Akashi, Japan
Hyogo Cancer Center
🇯🇵Akashi, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Japan
National Hospital Organization Asahikawa Medical Center
🇯🇵Asahikawa, Japan
Juntendo University Hospital
🇯🇵Bunkyō-Ku, Japan
Nippon Medical School Hospital
🇯🇵Bunkyō-Ku, Japan
Tokyo Medical And Dental University, Medical Hospital
🇯🇵Bunkyō-Ku, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
National Cancer Center Hospital
🇯🇵Chuo Ku, Japan
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