Status:
COMPLETED
Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
Lead Sponsor:
Fundación GECP
Conditions:
Small Cell Lung Cancer (SCLC)
Eligibility:
All Genders
18+ years
Brief Summary
This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study. The study is based on the collection of data about the patients treated with Durvalumab af...
Detailed Description
Lung Cancer represent approximately 13% of total cancer diagnoses worldwide and continues to be the leading cause of cancer-related mortality. Stage III represents between 25-30% of NSCLC and the majo...
Eligibility Criteria
Inclusion
- 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).
- Age ≥ 18 years at time of study Entry
- Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
- Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
- Patients must have been treated with at least one dose of durvalumab within the EAP
- 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
- Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
- Patients who were accepted in the EAP, but did not receive treatment.
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP
Key Trial Info
Start Date :
May 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT04285866
Start Date
May 21 2020
End Date
December 31 2021
Last Update
June 7 2022
Active Locations (39)
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1
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain, 07198
3
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
4
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402