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OpenTrials
Completed

NCT Number: 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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital-Hsinchu Branch, Hsinchu, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 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)

  2. Overall survival (OS)

    Time frame: 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 outcomes

  1. Safety measures with retrospective collection of AESIs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2020
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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