A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
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)
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1) — Up to approximately 6 years PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.
Overall Survival (OS), in PD-L1-negative participants. — Up to approximately 6 years OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
Trial sites (247)
Facility
City
Region
Status
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.