Non-small-Cell Lung Cancer
Conditions
Keywords
Atezolizumab
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
Interventions
None listed
Sponsors
Japan Lung Cancer Society
Chugai Pharmaceutical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18 months survival rate | Baseline up to 18 Months | Percentage of participants alive 18 months after initiation of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 months survival rate | Up to 12 months | Percentage of participants alive 12 months after initiation of treatment |
| 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) |
| 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 |
| 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 |
| Disease Control Rate(DCR) | Up to 4 years | Percentage of patients with controled disease 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 4 years) | Duration of Response 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 |
| 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. |
| 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 |
Countries
Japan
Outcome results
None listed