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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT04285866
Eligibility Criteria:
Inclusion Criteria:
1. 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).
2. Age ≥ 18 years at time of study Entry
3. Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
4. Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
5. Patients must have been treated with at least one dose of durvalumab within the EAP
6. Alive patients must have signed, dated and IRB/EC-approved written informed consent\* form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Exclusion Criteria:
1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
2. Patients who were accepted in the EAP, but did not receive treatment.
3. 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
Study:
NCT04285866
Study Brief:
Protocol Section:
NCT04285866