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Clinical Trials in the UK / NCT05984277
Active, not recruiting Phase 3

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

NCT05984277 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-10-24
Last updated
2026-07-28

Condition(s) studied

Metastatic Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

VolrustomigPembrolizumabCarboplatinPaclitaxelPemetrexed

Volrustomig: Volrustomig

Pembrolizumab: Pembrolizumab

Carboplatin: Carboplatin

Paclitaxel: Paclitaxel

Pemetrexed: Pemetrexed

Study summary

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 \< 50%.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Histologically or cytologically documented squamous or non-squamous NSCLC. * Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation. * Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements. * Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies. Key Exclusion Criteria: * Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded. * Spinal cord compression. * Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. * History of another primary malignancy except for: 1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease. * As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.

Primary outcome measure(s)

Trial sites (247)

FacilityCityRegionStatus
Research Site Hot Springs Arkansas
Research Site Springdale Arkansas
Research Site Long Beach California
Research Site Lone Tree Colorado
Research Site Fort Myers Florida
Research Site Orlando Florida
Research Site St. Petersburg Florida
Research Site West Palm Beach Florida
Research Site Fort Wayne Indiana
Research Site Indianapolis Indiana
Research Site Des Moines Iowa
Research Site Lexington Kentucky
Research Site Louisville Kentucky
Research Site Annapolis Maryland
Research Site Baltimore Maryland
Research Site Silver Spring Maryland
Research Site Towson Maryland
Research Site Detroit Michigan
Research Site Grand Island Nebraska
Research Site Lincoln Nebraska
Research Site Omaha Nebraska
Research Site East Syracuse New York
Research Site Fresh Meadows New York
Research Site Columbus Ohio
Research Site Columbus Ohio
Research Site Dayton Ohio
Research Site Portland Oregon
Research Site Horsham Pennsylvania
Research Site Pittsburgh Pennsylvania
Research Site Memphis Tennessee
Research Site Nashville Tennessee
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site Irving Texas
Research Site Lancaster Texas
Research Site Fairfax Virginia
Research Site Tacoma Washington
Research Site CABA Argentina
Research Site CABA Argentina
Research Site CABA Argentina

+ 207 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05984277 on ClinicalTrials.gov ↗ ← All trials in the UK