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: 30 Jun 2026
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Durvalumab Anti-PD-L1 monoclonal Antibody monotherapy | Drug: Durvalumab (MEDI4736) Anti-PD-L1 monoclonal Antibody monotherapy |
| Active Comparator: Arm 2: Standard of Care Standard of Care Platinum-Based chemotherapy | Drug: Paclitaxel + carboplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Gemcitabine + cisplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Gemcitabine + carboplatin Chemotherapy Agents Other Name: Platinum based Standard of Care Chemotherapy Drug: Pemetrexed + cisplatin Chemotherapy Agent Other Name: Platinum based Standard of Care Chemotherapy Drug: Pemetrexed + carboplatin Chemotherapy Agent Other Name: Platinum based Standard of Care Chemotherapy |
