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

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

Detailed Description
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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.

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

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EAP patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |