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Clinical Trial Summary

This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)


Clinical Trial Description

Patients with stage IV NSCLC will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy). The dual primary objectives of this study are to assess the efficacy of durvalumab versus SoC in terms of OS (Overall Survival) in all randomized patients and in patients who are at low risk of EM (early mortality) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03003962
Study type Interventional
Source AstraZeneca
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 2, 2017
Completion date October 29, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02542293 - Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE). Phase 3