Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Gemcitabine; Paclitaxel; Pemetrexed

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:

• 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]