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

AstraZeneca

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Industry

Identifiers

NCT04529564

D4194R00023

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

106 participants in 1 patient group

EAP patients

Description:

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.