NCT03003962|Active Not RecruitingPhase 3ResultsDMCFDA Drug

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

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

AstraZeneca ClinicalTrials.gov

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2 other identifiers

D419AC000022018-001375-21

Study Type

interventional

Target

669

Locations

12 countries

Sites

Timeline

RegisteredDec 2016

StartedJan 2017

CompletionJun 2026

Brief 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)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

669

participants targeted

Target at P75+ for phase_3

Timeline

2mo left

Started Jan 2017

Longer than P75 for phase_3

Geographic Reach

12 countries

92 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.5 years study duration

Study Progress98%

Jan 2017Jun 2026

First Submitted

Initial submission to the registry

December 15, 2016

Completed

13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed

5 days until next milestone

Study Start

First participant enrolled

January 2, 2017

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

December 26, 2023

Completed

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

5.8 years

First QC Date

December 15, 2016

Results QC Date

October 23, 2023

Last Update Submit

March 10, 2026

Conditions

Non Small Cell Lung Carcinoma NSCLC

Keywords

NSCLCPD-L1Durvalumab (MEDI4736)OS

Outcome Measures

Primary Outcomes (2)

Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022]
OS in Participants With LREM
OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)

Secondary Outcomes (42)

OS in PD-L1 TC >= 50% Analysis Set
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
OS in PD-L1 TC >= 50% LREM Analysis Set
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months DCO 27 October 2022)
PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
+37 more secondary outcomes

Study Arms (2)

Arm 1: Durvalumab

EXPERIMENTAL

Anti-PD-L1 monoclonal Antibody monotherapy

Drug: Durvalumab (MEDI4736)

Arm 2: Standard of Care

ACTIVE COMPARATOR

Standard of Care Platinum-Based chemotherapy

Drug: Paclitaxel + carboplatinDrug: Gemcitabine + cisplatinDrug: Gemcitabine + carboplatinDrug: Pemetrexed + cisplatinDrug: Pemetrexed + carboplatin

Interventions

Durvalumab (MEDI4736)DRUG

Anti-PD-L1 monoclonal Antibody monotherapy

Arm 1: Durvalumab

Paclitaxel + carboplatinDRUG

Chemotherapy Agents