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First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

NCT03798535

CompletedN/A

Sponsor: AstraZeneca

Conditions: NSCLC

Countries: Australia, Belgium, France, Germany, Israel, Italy, Netherlands, Norway

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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).
Locations (254)
  • Ballarat, Australia
  • Bankstown, Australia
  • Bedford Park, Australia
  • Bendigo, Australia
  • Bentleigh East, Australia
  • Bowral, Australia
  • Box Hill, Australia
  • Campbelltown, Australia
  • Camperdown, Australia
  • Canberra, Australia
  • Clayton, Australia
  • Coffs Harbour, Australia
  • Douglas, Australia
  • Elizabeth Vale, Australia
  • Frankston, Australia
  • Hamlyn Terrace, Australia
  • Hervey Bay, Australia
  • Hobart, Australia
  • Joondalup, Australia
  • Kingswood, Australia
  • Liverpool, Australia
  • Malvern, Australia
  • Melbourne, Australia
  • Melbourne, Australia
  • Murdoch, Australia
  • Orange, Australia
  • Rockhampton, Australia
  • St Leonards, Australia
  • Subiaco, Australia
  • Traralgon, Australia
  • + 224 more on CT.gov