Clinical trial NCT03995875: Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
Official title: Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC, stageIII, Durvalumab, Japanese, Real world
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Japan Lung Cancer Society
First posted: 2019-06-24
Enrollment: 529
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of pneumonitis and AESI
timeFrame: 3 years
measure: To assess progression free survival (PFS) of durvalumab
timeFrame: PFS is assessed as PFS median for time of 3 years
Secondary outcomes:
measure: To assess overall survaival (OS) of durvalumab
timeFrame: OS is assessed as median OS for time of 3 years
measure: Incidence of pneumonitis and AESIs in patient subset populations
timeFrame: 3 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Toyoake
country: Japan
facility: Research Site
state: Aichi
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kasama
country: Japan
facility: Research Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Morioka
country: Japan
facility: Research Site
state: Iwate
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Matsubara
country: Japan
facility: Research Site
state: Mie
city: Natori
country: Japan
facility: Research Site
state: Miyagi
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Nishihara
country: Japan
facility: Research Site
state: Okinawa
city: Hirakata
country: Japan
facility: Research Site
state: Osaka
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Hidaka
country: Japan
facility: Research Site
state: Saitama
city: Izumo
country: Japan
facility: Research Site
state: Shimane
city: Mishima
country: Japan
facility: Research Site
state: Shizuoka
city: Mibu
country: Japan
facility: Research Site
state: Tochigi
city: Shimotsuke
country: Japan
facility: Research Site
state: Tochigi
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Koto
country: Japan
facility: Research Site
state: Tokyo
city: Mitaka
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Iwakuni
country: Japan
facility: Research Site
state: Yamaguchi
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
Study officials:
References: