Status:
COMPLETED
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
Lead Sponsor:
AstraZeneca
Conditions:
NSCLC
Eligibility:
All Genders
18-130 years
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 reco...
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: Australi...
Eligibility Criteria
Inclusion
- 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
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Key Trial Info
Start Date :
December 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 16 2024
Estimated Enrollment :
1156 Patients enrolled
Trial Details
Trial ID
NCT03798535
Start Date
December 19 2018
End Date
July 16 2024
Last Update
July 16 2025
Active Locations (254)
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1
Research Site
Ballarat, Australia, 3350
2
Research Site
Bankstown, Australia, 2200
3
Research Site
Bedford Park, Australia, 5042
4
Research Site
Bendigo, Australia, 3550