Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT03798535
Eligibility 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).
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT03798535
Study Brief:
Protocol Section:
NCT03798535