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Closed (no longer recruiting)Last updated: 21 December 2023

PEARL: This phase III trial is evaluating the safety of an immunotherapy drug (Durvalumab) and platinum based SoC chemotherapy as a first line treatment for patients with Non-Small Cell (NSC) Lung CancerA Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab Versus Standard of Care Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non-Small-Cell Lung Cancer (NSCLC)

Clinical summary

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

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer (EGFR and ALK).

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

PEARL

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab Versus Standard of Care Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non-Small-Cell Lung Cancer (NSCLC)

Eligibility

Inclusion

  • 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

  • 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]

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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