Real-world Data on Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area (PACIFIC AA)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT04529564
- Lead Sponsor
- AstraZeneca
- Brief Summary
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) time from initiation of the durvalumab therapy (index date) until earliest record of disease progression (estimate assessed up to 3 years) 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)
Overall survival (OS) time from durvalumab initiation date up to death or last date the patient was known to be alive (estimate assessed up to 5 years) Defined as the time from durvalumab initiation date up to death or last date the patient was known to be alive (for censored observations).
- Secondary Outcome Measures
Name Time Method Safety measures with retrospective collection of AESIs time from initiation of durvalumab therapy until stop treatment (assessed up to 3 years) * Require concomitant use of systemic corticoids, immunosuppressants and/or endocrine therapies, or
* Leading to durvalumab temporary interruption, or
* Leading to durvalumab permanent discontinuation.
Trial Locations
- Locations (12)
Chang Gung Medical Foundation-Kaohsiung Branch
🇨🇳Kaohsiung, Taiwan
Chang Gung Medical Foundation-Keelung Branch
🇨🇳Keelung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital-Hsinchu Branch
🇨🇳Hsinchu, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan