First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area

Study Design: The study is an observational review of medical records of patients diagnosed with unresectable stage III NSCLC in Taiwan, participating in an early access program (EAP). Physicians having treated patients in the EAP will be asked to recruit these patients to have their data abstracted from their medical records. Data will only be collected from routine clinical care.

Data Source(s): Centre staff will extract de-identified data from patient's medical charts. All collected data will be retrospective at time of extractions.

Study Population: Patients diagnosed with an unresectable stage III NSCLC, having not progressed after a CRT and who have received at least one dose of durvalumab following the CRT within the EAP will be the target population.

Exposure(s): Clinical characteristics, details of treatments (previous therapies, subsequent therapies), durvalumab exposure and serious AESIs Primary Outcome(s): PFS and OS. Sample Size Estimations: A target of 140 patients is estimated in the study.

Inclusion Criteria:

1. Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
2. Adult of age ≥ 20 years at time of study entry
3. Patients must have been enrolled in one of the Pacific durvalumab EAPs

Exclusion Criteria:

1. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).

The study will include all patients who have participated in the EAP between 1 September 2017 until the end of EAP enrolment (5 Nov 2018 in Taiwan) and have received at least 1 dose of durvalumab prior to the present study start. Patients may participate in other clinical trials during this follow-up period.