Study identifier:D4194R00023
ClinicalTrials.gov identifier:NCT04529564
EudraCT identifier:N/A
CTIS identifier:N/A
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area.
Carcinoma, Non-Small-Cell Lung
N/A
No
-
All
106
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area
Study Design: The study is an observational review of medical records of patients diagnosed with unresectable stage III NSCLC in Taiwan, participating in an early access program (EAP). Physicians having treated patients in the EAP will be asked to recruit these patients to have their data abstracted from their medical records. Data will only be collected from routine clinical care. Data Source(s): Centre staff will extract de-identified data from patient’s medical charts. All collected data will be retrospective at time of extractions. Study Population: Patients diagnosed with an unresectable stage III NSCLC, having not progressed after a CRT and who have received at least one dose of durvalumab following the CRT within the EAP will be the target population. Exposure(s): Clinical characteristics, details of treatments (previous therapies, subsequent therapies), durvalumab exposure and serious AESIs Primary Outcome(s): PFS and OS. Sample Size Estimations: A target of 140 patients is estimated in the study.
Location
Location
Taipei, Taiwan, Province of China
Location
Taichung, Taiwan, Province of China
Location
Taoyuan, Taiwan, Province of China
Location
Kaohsiung, Taiwan, Province of China
Location
Keelung, Taiwan, Province of China
Location
Taichung, Taiwan, Province of China
Location
Taipei, Taiwan, Province of China
Location
Hsinchu, Taiwan, Province of China
Arms | Assigned Interventions |
---|---|
EAP patients The PACIFIC-AA is designed to enroll stage III unresectable NSCLC patients who received durvalumab after completion of chemoradiation therapy within an early access program in Taiwan during 2018 to 2019. | - |
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