NCT04529564

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Timeline

• Start date: 2020-06-12
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2020-08-27
• Last updated: 2024-08-13

Locations

12 sites across 1 country: Taiwan