Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-31 @ 4:33 AM
Study NCT ID:
NCT03798535
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2018-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a non-interventional/observational cohort of unresectable Stage III NSCLC patients treated with durvalumab.
The study will be carried out as a retrospective review of established medical records of unresectable Stage III NSCLC patients treated with durvalumab.
The study will be carried out as a retrospective review of established medical records of unresectable Stage III NSCLC patients treated with durvalumab.
Detailed Description:
This is a non-interventional/observational study including unresectable Stage III NSCLC patients treated with durvalumab. Patients will be selected from the following participating countries: Australia, Belgium, Israel, Netherlands, Norway, France, Germany, Italy, Switzerland, Spain\* and the United Kingdom.
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 unresectable Stage III NSCLC to durvalumab start date (index date).
* The second chart extraction will be triggered at time of estimated maturity of PFS data.
* The third chart extraction will be triggered at time of estimated maturity of OS data.
* The fourth (final) chart extractions will occur 5-years after EAP enrolment to provide final PFS and OS data, together with updated results for all secondary and descriptive endpoints.
* The dates for the second through fourth 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) together with the distribution of PFS and OS observed in the PACIFIC trial.
* Spain only contributed to DE1 and DE2.
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 unresectable Stage III NSCLC to durvalumab start date (index date).
* The second chart extraction will be triggered at time of estimated maturity of PFS data.
* The third chart extraction will be triggered at time of estimated maturity of OS data.
* The fourth (final) chart extractions will occur 5-years after EAP enrolment to provide final PFS and OS data, together with updated results for all secondary and descriptive endpoints.
* The dates for the second through fourth 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) together with the distribution of PFS and OS observed in the PACIFIC trial.
* Spain only contributed to DE1 and DE2.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: