Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC; AYAME study

Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC; AYAME study - Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC; AYAME study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037090

Enrollment

500

Registered

2019-06-17

Start date

2019-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable stage III NSCLC

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy. Include patients with recurrent after resection of the primary site and judged to have unresectable stage III NSCLC (N2-3). Patients who provided written informed consent.

Exclusion criteria

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 first diagnosis to the end of the treatment of durvalumab. Age < 20

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHajime Kanazaki

A2healthcare Corporation Clinical Development Department4

AYAME_Core@a2healthcare.com03-3830-1075

Outcome results