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

Running, not enrolling · Phase 3

Conditions studied: Non Small Cell Lung Carcinoma NSCLC

In brief

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)

Key facts

Study ID

NCT03003962

Run by

AstraZeneca

People needed

669

Starts

2017-01-02

Expected to finish

2026-06-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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]

Where it is running

• Research Site — Box Hill, Australia
• Research Site — Gosford, Australia
• Research Site — Kogarah, Australia
• Research Site — St Leonards, Australia
• Research Site — Beijing, China
• Research Site — Beijing, China
• Research Site — Beijing, China
• Research Site — Bengbu, China
• Research Site — Changchun, China
• Research Site — Changsha, China
• Research Site — Chengdu, China
• Research Site — Chongqing, China
• Research Site — Guangzhou, China
• Research Site — Guangzhou, China
• Research Site — Haikou, China
• Research Site — Hangzhou, China
• Research Site — Hangzhou, China
• Research Site — Hangzhou, China
• Research Site — Hangzhou, China
• Research Site — Jinan, China
• Research Site — Linhai, China
• Research Site — Nanchang, China
• Research Site — Nanjing, China
• Research Site — Ningbo, China
• Research Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.