Prospective multicenter observational study of adjuvant atezolizumab in resected non-small-cell lung cancer
Not Applicable
Recruiting
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-jRCT1031220647
- Lead Sponsor
- Ikeda Norihiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
1) Patients 18 years of age or older at the time of written consent.
2) Patients with PD-L1 positive non-small cell lung cancer who had received complete resection and are scheduled to receive atezolizumab adjuvant therapy in clinical practice, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
3) Patients who had received appropriate explanation about the study and was willing to give written consent.
Exclusion Criteria
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 3-year disease-free survival rate
- Secondary Outcome Measures
Name Time Method (1) DFS<br>(2) Disease-free survival rate<br>(3) OS<br>(4) Recurrence site<br>(5) Incidence rate of Adverse Events<br>(6) irAE incidence rate<br>(7) the following items for subgroup analysis<br> 1) sex<br> 2) age at the time of consent<br> 3) ECOG PS<br> 4) smoking history<br> 5) histological type<br> 6) preoperative clinical stage and postoperative pathological stage<br> 7) prescribed regimen of postoperative adjuvant chemotherapy<br> 8) administrated cycle number of postoperative adjuvant chemotherapy<br> 9) completion or discontinuation of Atezolizumab treatment<br> 10) PD-L1 status<br> 11) with or without irAE onset<br> 12) driver mutation<br> 13) Other by patient background