Carcinoma, Non-Small-Cell LungAYAMENCT03995875
Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 43 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 529 participants
- Where
- 43 sitesJapan
- Study dates
- 25 Jul 2019to 11 Jan 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
- Patients who provided written informed consent.
Who cannot join
- 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
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Research Site
Akashi, Hyōgo
Research Site
Asahikawa, Hokkaido
Research Site
Bunkyo, Tokyo
Research Site
Chiba
Research Site
Chūō, Tokyo
Research Site
Fukuoka
Research Site
Hidaka, Saitama
Research Site
Hirakata, Osaka
Research Site
Hiroshima
Research Site
Iwakuni, Yamaguchi
Research Site
Izumo, Shimane
Research Site
Kanazawa, Ishikawa-ken
Research Site
Kasama, Ibaraki
Research Site
Kobe, Hyōgo
Research Site
Koto, Tokyo
Research Site
Kurume, Fukuoka
Research Site
Kyoto
Research Site
Maebashi, Gunma
Research Site
Matsubara, Mie-ken
Research Site
Matsuyama, Ehime
Research Site
Mibu, Tochigi
Research Site
Mishima, Shizuoka
Research Site
Mitaka, Tokyo
Research Site
Morioka, Iwate
Research Site
Nagasaki
Research Site
Nagoya, Aichi-ken
Research Site
Natori-shi, Miyagi
Research Site
Niigata
Research Site
Nishihara, Okinawa
Research Site
Okayama
Research Site
Osaka
Research Site
Sagamihara, Kanagawa
Research Site
Saitama
Research Site
Sakai, Osaka
Research Site
Sapporo, Hokkaido
Research Site
Sayama, Osaka
Research Site
Sendai, Miyagi
Research Site
Shimotsuke, Tochigi
Research Site
Shinjuku, Tokyo
Research Site
Tokushima
Research Site
Toyoake, Aichi-ken
Research Site
Wakayama
Research Site
Yokohama, Kanagawa
About this study
Official title: Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
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.
Read the detailed description
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
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, stageIII, Durvalumab, Japanese, Real world
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: PFS is assessed as PFS median for time of 3 years
Secondary outcomes (2)
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.
Measured: OS is assessed as median OS for time of 3 years
Incidence of pneumonitis and AESIs in patient subset populations
Summary of pneumonitis and AESIs in each durvalumab treatment status in patient subset populations
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start25 Jul 2019
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 529 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japan Lung Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995875
- Sponsor's protocol ID
- D4194R00013
- Acronym
- AYAME
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
Publications
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.
PubMed 42152809Kenmotsu 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.
PubMed 40835220
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
- ClinicalTrials.gov ID
- NCT03995875
- Acronym / sponsor ID
- AYAME / D4194R00013
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, stageIII, Durvalumab, Japanese, Real world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Japan Lung Cancer Society
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
- Patients who provided written informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pneumonitis and AESI
Time frame: 3 years
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
To assess progression free survival (PFS) of durvalumab
Time frame: PFS is assessed as PFS median for time of 3 years
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.
2 secondary outcomes
To assess overall survaival (OS) of durvalumab
Time frame: OS is assessed as median OS for time of 3 years
Incidence of pneumonitis and AESIs in patient subset populations
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 42152809Yamamoto 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.
- Derived from this study: PubMed 40835220Kenmotsu 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.
- CSR Synopsis AYAME studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 43 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumonitis and AESI (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.