Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
AYAME
1 other identifier
observational
529
1 country
43
Brief Summary
This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedStudy Start
First participant enrolled
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2024
CompletedDecember 5, 2024
December 1, 2024
4.5 years
June 6, 2019
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of pneumonitis and AESI
Pneumonitis and AESIs will be summarized at least following categories * Pneumonitis within three years from the start of durvalmab treatment * Pneumonitis and AESIs during treatment period of durvalmab * Pneumonitis and AESIs after durvalmab treatment
3 years
To assess progression free survival (PFS) of durvalumab
PFS is defined as the time from the start of durvalumab treatment to first progression disease (PD) or death, whichever is earlier. In case the patients without progression or death, patients will be censored at the last follow-up date or the first date of the 1st subsequent treatment, whichever is earlier.
PFS is assessed as PFS median for time of 3 years
Secondary Outcomes (2)
To assess overall survaival (OS) of durvalumab
OS is assessed as median OS for time of 3 years
Incidence of pneumonitis and AESIs in patient subset populations
3 years
Eligibility Criteria
Total 500 patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy will be enrolled. The patients should be registered consecutively in each site.
You may qualify if:
- Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
- Patients who provided written informed consent.
You may not qualify if:
- Patients who would join Post Marketing Surveyllance 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 durvalumab treatment
- Age \< 20
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Japan Lung Cancer Societycollaborator
Study Sites (43)
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Toyoake, Aichi-ken, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kasama, Ibaraki, Japan
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Matsubara, Mie-ken, Japan
Research Site
Natori-shi, Miyagi, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Nishihara, Okinawa, Japan
Research Site
Hirakata, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Hidaka, Saitama, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Mishima, Shizuoka, Japan
Research Site
Mibu, Tochigi, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Koto, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Iwakuni, Yamaguchi, Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Kyoto, Japan
Research Site
Nagasaki, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Research Site
Tokushima, Japan
Research Site
Wakayama, Japan
Related Publications (1)
Kenmotsu H, Saito Y, Ninomiya K, Uematsu S, Akdemir B, Fukui A, Koto R, Fujiwara M, Iwao C, Kitagawa H, Yoshino I, Gemma A, Mitsudomi T, Yamamoto N. Long-Term Safety and Effectiveness of Durvalumab in Unresectable Stage III NSCLC in Japan: A Multicenter Prospective Study (AYAME). J Thorac Oncol. 2025 Aug 18:S1556-0864(25)01014-7. doi: 10.1016/j.jtho.2025.08.010. Online ahead of print.
PMID: 40835220DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 24, 2019
Study Start
July 25, 2019
Primary Completion
January 11, 2024
Study Completion
January 11, 2024
Last Updated
December 5, 2024
Record last verified: 2024-12