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.

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

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • National Taiwan University Hospital-Hsinchu Branch
  • Kaohsiung, Taiwan
    • Chang Gung Medical Foundation-Kaohsiung Branch
  • Keelung, Taiwan
    • Chang Gung Medical Foundation-Keelung Branch
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taichung, Taiwan
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • TRI-Service General Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan
    • Chang Gung Medical Foundation-Linkou Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients who have participated in the EAP between 1 September 2017 until the end of EAP enrolment (5 Nov 2018 in Taiwan) and have received at least 1 dose of durvalumab prior to the present study start. Patients may participate in other clinical trials during this follow-up period.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
EAP patients; 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?

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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Reto Huggenberger, AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis Redacted

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D4194R00023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No