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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037090
Receipt No. R000042121
Scientific Title Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC ;AYAME study
Date of disclosure of the study information 2019/06/17
Last modified on 2020/06/15

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Basic information
Public title Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC
;AYAME study
Acronym Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC
;AYAME study
Scientific Title Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC
;AYAME study
Scientific Title:Acronym Real world evidence of long-term safety and efficacy in patients treated with durvalumab after concurrent chemoradiation for unresectable stage III NSCLC
;AYAME study
Region
Japan

Condition
Condition Unresectable stage III NSCLC
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary objectives
To assess ILDs and AESIs that occurred within three years from the start of durvalumab treatment in patients who are diagnosed stage III unresectable NSCLC treated durvalumab following chemoradiation therapy
To assess PFS from start of durvalumab treatment in patients who are diagnosed stage III unresectable NSCLC and treated durvalumab following chemoradiation therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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
Key secondary outcomes 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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Masahisa
Middle name
Last name Jinushi
Organization AstraZeneca K.K.
Division name Head of Oncology Medical
Zip code 530-0011
Address 3-1, Ofuka-cho, Kita-ku, Osaka-city,Osaka 530-0011,Japan
TEL 06-7711-3044
Email Masahisa.Jinushi@astrazeneca.com

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Konuki
Organization A2healthcare Corporation
Division name Clinical Research Department
Zip code 112-0002
Address 1-4-1,Koishikawa,Bunkyo-Ku,Tokyo 112-0002 JAPAN
TEL 03-3830-1075
Homepage URL
Email AYAME_Core@a2healthcare.com

Sponsor
Institute AstraZeneca K.K.
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor The Japan Lung Cancer Society
Name of secondary funder(s)

IRB Contact (For public release)
Organization during the adjustment
Address during the adjustment
Tel 03-3830-1075
Email AYAME_Core@a2healthcare.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 04 Month 26 Day
Date of IRB
2019 Year 06 Month 27 Day
Anticipated trial start date
2019 Year 07 Month 25 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient's information
Cancer information
Chemoradiation therapy information before durvalumab treatment
Durvalumab treatment information
Subsequent treatment information
Safety events
ILDs including radiation pneumonitis .all grade
AESIs
Efficacy

Management information
Registered date
2019 Year 06 Month 17 Day
Last modified on
2020 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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