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

NCT03003962 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2026-03-11

Study results available
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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)

Conditions

  • Non Small Cell Lung Carcinoma NSCLC

Interventions

DRUG

Durvalumab (MEDI4736)

Anti-PD-L1 monoclonal Antibody monotherapy

DRUG

Paclitaxel + carboplatin

Chemotherapy Agents

DRUG

Gemcitabine + cisplatin

Chemotherapy Agents

DRUG

Gemcitabine + carboplatin

Chemotherapy Agents

DRUG

Pemetrexed + cisplatin

Chemotherapy Agent

DRUG

Pemetrexed + carboplatin

Chemotherapy Agent

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2022-10-27
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Hungary
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003962 on ClinicalTrials.gov