Real-world Data on Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area (PACIFIC AA)
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area.
1 other identifier
observational
106
1 country
12
Brief Summary
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2020
CompletedFirst Submitted
Initial submission to the registry
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2023
CompletedAugust 13, 2024
August 1, 2024
3 years
July 1, 2020
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Progression free survival (PFS)
Defined as the time from initiation of the durvalumab therapy (index date) until earliest record of disease progression (including metastatic disease) determined by physicians' assessment, metastatic recurrence or death (if no progression) or end of follow-up (for censored observations)
time from initiation of the durvalumab therapy (index date) until earliest record of disease progression (estimate assessed up to 3 years)
Overall survival (OS)
Defined as the time from durvalumab initiation date up to death or last date the patient was known to be alive (for censored observations).
time from durvalumab initiation date up to death or last date the patient was known to be alive (estimate assessed up to 5 years)
Secondary Outcomes (1)
Safety measures with retrospective collection of AESIs
time from initiation of durvalumab therapy until stop treatment (assessed up to 3 years)
Study Arms (1)
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.
Eligibility Criteria
The study will include all patients who have participated in the EAP between 1 September 2017 until the end of EAP enrolment (5 Nov 2018 in Taiwan) and have received at least 1 dose of durvalumab prior to the present study start. Patients may participate in other clinical trials during this follow-up period.
You may qualify if:
- Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
- Adult of age ≥ 20 years at time of study entry
- Patients must have been enrolled in one of the Pacific durvalumab EAPs
You may not qualify if:
- \. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
National Taiwan University Hospital-Hsinchu Branch
Hsinchu, Taiwan
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung City, Taiwan
Chang Gung Medical Foundation-Keelung Branch
Keelung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Reto Huggenberger
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2020
First Posted
August 27, 2020
Study Start
June 12, 2020
Primary Completion
June 29, 2023
Study Completion
June 29, 2023
Last Updated
August 13, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share