Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC ;AYAME study
Not Applicable
- Conditions
- nresectable stage III NSCLC
- Registration Number
- JPRN-UMIN000037090
- Lead Sponsor
- AstraZeneca K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 511
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who would join PMS for durvalumab. Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from the time of initial diagnosis to the end of the treatment of durvalmab. Age < 20
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.ILDs and AESIs will be summarized at least following categories ILDs within three years from the start of durvalmab treatment ILDs and AESIs during treatment period of durvalmab ILDs and AESIs after durvalmab treatment 2.PFS and PFS rates at 12 months,18 months and 24 months from the start of durvalmab treatment
- Secondary Outcome Measures
Name Time Method 1.OS and OS rates at 24 months and 36 months from the start of durvalmab treatment 2.Summary of ILDs and AESIs in each durvalumab treatment status in patient subset populations 3.PFS and OS in patient subset populations 4.OR,TTDM 5.Reasons of treatment discontinuation of durvalumab (discontinuation by reasons of AE or PD or others) 6.Detailed subsequent treatments regimens until 3 years after start of durvalumab treatment