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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— AYAME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995875
• Other study ID #: D4194R00013
• Status: Completed
• Start date: July 25, 2019
• Est. completion date: January 11, 2024

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Japan	Research Site	Akashi	Hyogo
Japan	Research Site	Asahikawa	Hokkaido
Japan	Research Site	Bunkyo	Tokyo
Japan	Research Site	Chiba
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Fukuoka
Japan	Research Site	Hidaka	Saitama
Japan	Research Site	Hirakata	Osaka
Japan	Research Site	Hiroshima
Japan	Research Site	Iwakuni	Yamaguchi
Japan	Research Site	Izumo	Shimane
Japan	Research Site	Kanazawa	Ishikawa
Japan	Research Site	Kasama	Ibaraki
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Koto	Tokyo
Japan	Research Site	Kurume	Fukuoka
Japan	Research Site	Kyoto
Japan	Research Site	Maebashi	Gunma
Japan	Research Site	Matsubara	Mie
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Mibu	Tochigi
Japan	Research Site	Mishima	Shizuoka
Japan	Research Site	Mitaka	Tokyo
Japan	Research Site	Morioka	Iwate
Japan	Research Site	Nagasaki
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Natori	Miyagi
Japan	Research Site	Niigata
Japan	Research Site	Nishihara	Okinawa
Japan	Research Site	Okayama
Japan	Research Site	Osaka
Japan	Research Site	Osakasayama	Osaka
Japan	Research Site	Sagamihara	Kanagawa
Japan	Research Site	Saitama
Japan	Research Site	Sakai	Osaka
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Shimotsuke	Tochigi
Japan	Research Site	Shinjuku	Tokyo
Japan	Research Site	Tokushima
Japan	Research Site	Toyoake	Aichi
Japan	Research Site	Wakayama
Japan	Research Site	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Japan Lung Cancer Society

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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