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.
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
Study Type
OBSERVATIONAL
Enrollment
1,026
18 months survival rate
Percentage of participants alive 18 months after initiation of treatment
Time frame: Baseline up to 18 Months
Overall Survival(OS)
OS was defined as the time from the first day of study treatment to death due to any cause
Time frame: Up to death (up to 4 years)
12 months survival rate
Percentage of participants alive 12 months after initiation of treatment
Time frame: Up to 12 months
24 months survival rate
Percentage of participants alive 24 months after initiation of treatment
Time frame: 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)
Time frame: 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
Time frame: Up to 4 years
Objective Response Rate(ORR)
Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
Time frame: Up to disease progression or death whichever occurs first (up to 4 years)
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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 City, Japan
Nippon Medical School Hospital
Bunkyō City, Japan
Tokyo Medical And Dental University, Medical Hospital
Bunkyō City, Japan
...and 188 more locations
Disease Control Rate(DCR)
Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
Time frame: Up to 4 years
Duration of Response(DOR)
Duration of Response as Assessed by the Investigator According to RECIST v1.1
Time frame: 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
Time frame: 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.
Time frame: Day 1 of first cycle(21-day cycle), then every 12 weeks until disease progression or until treatment discontinuation(Up to 4 years)