Study of Durvalumab alone or Chemotherapy for patients with Advanced Non Small-Cell Lung Cancer (PEARL)

Study identifier:D419AC00002

ClinicalTrials.gov identifier:NCT03003962

EudraCT identifier:2018-001375-21

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non Small-Cell Lung Cancer

Medical condition

Non Small Cell Lung Carcinoma NSCLC

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab (MEDI4736), Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin, Pemetrexed + carboplatin

Sex

All

Actual Enrollment

669

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 02 Jan 2017
Primary Completion Date: 27 Oct 2022
Estimated Study Completion Date: 04 Jun 2026

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria