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

Completed

• Conditions: NSCLC

• Registration Number: NCT03798535
• Lead Sponsor: AstraZeneca

Brief Summary

This is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.

The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.

Detailed Description

This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain

Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.

* First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of stage III unresectable NSCLC and the durvalumab start date (index date).

* The second chart extraction will be triggered at time of estimated maturity of PFS data to provide an accurate measure of the PFS outcome.

* The third chart extraction will be triggered at time of estimated maturity of OS data to provide an accurate measure of the OS outcome• The fourth and fifth chart extractions will occur approximately 3-years and 5-years after enrolment

* The dates for the second through fifth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) and any available data on PFS and OS observed in the first extraction together with the distribution of PFS and OS observed in the PACIFIC trial.

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-10
• Primary Completion: 2024-07-16
• Study Completion: 2024-07-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1156

Inclusion Criteria

• Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
• Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority
• Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8)
• Patients must have been enrolled in one of the durvalumab EAPs Patients must have been treated with at least one dose of durvalumab within the EAP prior to the study entry and between start of EAP in the country, from September 2017 or later up to end of EAP enrolment or MA + three months (estimated as maximum to 30 December 2018) (whichever occurs earlier).

Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS)	PFS is assessed as PFS rates at 12 months and 18 months, and as PFS median for a period of time of 5 years. From Index date (first dose of durvalumab) to progression or death whichever came first, assessed up to 5 years.	PFS defined as time from the index date (date of the first dose of durvalumab) to the date of investigator-determined disease progression or death (if no progression) or the end of follow-up
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS)	OS is assessed as OS rates at 2, 3 and 5 years, and as OS median for a period of time of 5 years. From Index date (first dose of durvalumab) to death or end of follow up, whichever came first, assessed during 5 years.	OS following durvalumab regimen received from the index date to death or end of follow-up.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Stoke on Trent, United Kingdom