First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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).
EXCLUSION CRITERIA
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
NSCLC
Age (in years)
18 - 130
Participants needed
1159
Est. Completion Date
Dec 20, 2023
Treatment type
Observational
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT03798535
Study number
D4194R00005
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