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Clinical Trial Summary

This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.


Clinical Trial Description

This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity. Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04712903
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date December 16, 2020
Completion date June 21, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03043872 - Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) Phase 3
Completed NCT04449861 - Durvalumab Plus Chemotherapy in ES-SCLC (Oriental) Phase 3