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Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC

NCT ID: NCT03995875

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

529 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-25

Study Completion Date

2024-01-11

Brief Summary

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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

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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

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Carcinoma, Non-Small-Cell Lung

Keywords

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NSCLC, stageIII, Durvalumab, Japanese, Real world

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
* Patients who provided written informed consent.

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Lung Cancer Society

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

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Toyoake, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Kurume, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kasama, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Morioka, Iwate, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Matsubara, Mie-ken, Japan

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Natori-shi, Miyagi, Japan

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Sendai, Miyagi, Japan

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Nishihara, Okinawa, Japan

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Hirakata, Osaka, Japan

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Sakai, Osaka, Japan

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Sayama, Osaka, Japan

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Hidaka, Saitama, Japan

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Izumo, Shimane, Japan

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Mishima, Shizuoka, Japan

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Mibu, Tochigi, Japan

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Shimotsuke, Tochigi, Japan

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Bunkyo, Tokyo, Japan

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Chūō, Tokyo, Japan

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Koto, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Iwakuni, Yamaguchi, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Kyoto, , Japan

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Nagasaki, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Saitama, , Japan

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Tokushima, , Japan

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Wakayama, , Japan

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Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 40835220 (View on PubMed)

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D4194R00013&amp;attachmentIdentifier=4733ff81-2c99-433b-96f7-03136b7d8f3b&amp;fileName=AYAME_study_CSR_synopsis_version1.0_20241119_redacted.pdf&amp;versionIdentifier=

CSR Synopsis AYAME study

Other Identifiers

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D4194R00013

Identifier Type: -

Identifier Source: org_study_id