Active Not RecruitingPhase 3NCT03003962

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

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)

Checked against the public recordLast updated Jun 11, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations92
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: Durvalumab (MEDI4736); Drug: Paclitaxel + carboplatin; Drug: Gemcitabine + cisplatin; Drug: Gemcitabine + carboplatin; Drug: Pemetrexed + cisplatin; Drug: Pemetrexed + carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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\]

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteAnaheim, California
  • Research SiteBox Hill
  • Research SiteGosford
  • Research SiteKogarah
  • Research SiteSt Leonards
  • Research SiteBeijing
  • Research SiteBeijing
  • Research SiteBeijing
  • Research SiteBengbu
  • Research SiteChangchun
  • Research SiteChangsha
  • Research SiteChengdu

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 11, 2026. Always confirm current availability with the study team.

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