Real-world Data on Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area (PACIFIC AA)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529564
• Other study ID #: D4194R00023
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: June 29, 2023

Study information

• Verified date: October 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area

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 information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures

2. Adult of age = 20 years at time of study entry

3. Patients must have been enrolled in one of the Pacific durvalumab EAPs

Exclusion Criteria:

1. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital-Hsinchu Branch	Hsinchu
Taiwan	Chang Gung Medical Foundation-Kaohsiung Branch	Kaohsiung
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Safety measures with retrospective collection of AESIs	Require concomitant use of systemic corticoids, immunosuppressants and/or endocrine therapies, or; Leading to durvalumab temporary interruption, or; Leading to durvalumab permanent discontinuation.	time from initiation of durvalumab therapy until stop treatment (assessed up to 3 years)