Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
About the study
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)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria
- Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No sensitizing EGFR mutation and ALK rearrangement
- PD-L1 high expression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
EXCLUSION CRITERIA
Exclusion Criteria:
- Prior chemotherapy or any other systemic therapy for advanced NSCLC
- Prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
- Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment
- Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
- Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease]
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non Small Cell Lung Carcinoma NSCLC
Age (in years)
18 - 130
Phase
Phase 3
Participants needed
671
Est. Completion Date
Aug 20, 2026
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT03003962
Study number
D419AC00002
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