Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT03798535
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.
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.
Study:
NCT03798535
Study Brief:
Protocol Section:
NCT03798535