Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Japan Lung Cancer Society | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.
Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pneumonitis and AESI | Pneumonitis and AESIs will be summarized at least following categories
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess overall survaival (OS) of durvalumab | OS is defined as the time from the date of start of the durvalumab treatment until death due to any causes. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. | OS is assessed as median OS for time of 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42152809 | Derived | Yamamoto N, Kenmotsu H, Ninomiya K, Akdemir B, Uematsu S, Fukui A, Koto R, Fujiwara M, Iwao C, Kitagawa H, Yoshino I, Gemma A, Mitsudomi T, Saito Y. Interstitial Lung Disease in Patients With Unresectable Stage III NSCLC Treated With Chemoradiotherapy Followed by Durvalumab in Japan: Analysis From the Multicenter Prospective AYAME Study. Thorac Cancer. 2026 May;17(10):e70299. doi: 10.1111/1759-7714.70299. | |
| 40835220 |
| Label | URL |
|---|---|
| CSR Synopsis AYAME study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidence of pneumonitis and AESIs in patient subset populations | Summary of pneumonitis and AESIs in each durvalumab treatment status in patient subset populations | 3 years |
| 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 |
| Derived |
| 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. 2026 Jan;21(1):160-173. doi: 10.1016/j.jtho.2025.08.010. Epub 2025 Aug 18. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided