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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04529564

Enrollment

106

Registered

2020-08-27

Start date

2020-06-12

Completion date

2023-06-29

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Taiwan

Outcome results