A Study of Atezolizumab in Patients With Unresectable, Locally Advanced or Metastatic NSCLC (J-TAIL)
- Conditions
- Non-small-Cell Lung Cancer
- Registration Number
- NCT03645330
- Lead Sponsor
- Chugai Pharmaceutical
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1026
- 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.
- Patients who are considered to be 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 18 months survival rate Baseline up to 18 Months Percentage of participants alive 18 months after initiation of treatment
- Secondary Outcome Measures
Name Time Method 12 months survival rate Up to 12 months Percentage of participants alive 12 months after initiation of treatment
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years) 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.
24 months survival rate Up to 24 months Percentage of participants alive 24 months after initiation of treatment
Progression-Free Survival(PFS) Up to disease progression or death whichever occurs first (up to 4 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)
Duration of Response(DOR) From date of first objective response up to disease progression or death whichever occurs first (up to 4 years) Duration of Response as Assessed by the Investigator According to RECIST v1.1
Time to treatment failure (TTF) Up to 4 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
Objective Response Rate(ORR) Up to disease progression or death whichever occurs first (up to 4 years) Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
Disease Control Rate(DCR) Up to 4 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 4 years The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v4.0
Overall Survival(OS) Up to death (up to 4 years) OS was defined as the time from the first day of study treatment to death due to any cause
Trial Locations
- Locations (198)
Akashi Medical Center
🇯🇵Akashi, Japan
Hyogo Cancer Center
🇯🇵Akashi, Japan
Akita University Hospital
🇯🇵Akita, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Japan
Aomori Prefectural Central Hospital
🇯🇵Aomori, 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
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