ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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%.

Official Title

A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).

Quick Facts

Study Start:2023-10-24
Study Completion:2029-03-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05984277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically documented squamous or non-squamous NSCLC.
  2. * Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
  3. * Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
  4. * 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.
  1. * Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
  2. * Spinal cord compression.
  3. * 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.
  4. * History of another primary malignancy except for:
  5. 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.
  6. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  7. 3. Adequately treated carcinoma in situ without evidence of disease.
  8. * As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.

Contacts and Locations

Study Locations (Sites)

Research Site
Prescott, Arizona, 86301
United States
Research Site
Hot Springs, Arkansas, 71913
United States
Research Site
Springdale, Arkansas, 72762
United States
Research Site
Long Beach, California, 90806
United States
Research Site
Lone Tree, Colorado, 80124
United States
Research Site
Fort Myers, Florida, 33901
United States
Research Site
Gainesville, Florida, 32610
United States
Research Site
Orlando, Florida, 32827
United States
Research Site
St. Petersburg, Florida, 33705
United States
Research Site
West Palm Beach, Florida, 33401
United States
Research Site
Fort Wayne, Indiana, 46804
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
Des Moines, Iowa, 50309
United States
Research Site
Lexington, Kentucky, 40503
United States
Research Site
Louisville, Kentucky, 40206
United States
Research Site
Annapolis, Maryland, 21401
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Silver Spring, Maryland, 20904
United States
Research Site
Towson, Maryland, 21204
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Grand Island, Nebraska, 68803
United States
Research Site
Lincoln, Nebraska, 68506
United States
Research Site
Omaha, Nebraska, 68130
United States
Research Site
Albuquerque, New Mexico, 87102
United States
Research Site
East Syracuse, New York, 13057
United States
Research Site
Fresh Meadows, New York, 11366
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Columbus, Ohio, 43219
United States
Research Site
Dayton, Ohio, 45428
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Horsham, Pennsylvania, 19044
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
Memphis, Tennessee, 38104
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Nashville, Tennessee, 37212
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Irving, Texas, 75063
United States
Research Site
Lancaster, Texas, 75216
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24
Study Completion Date2029-03-23

Study Record Updates

Study Start Date2023-10-24
Study Completion Date2029-03-23

Terms related to this study

Keywords Provided by Researchers

  • metastatic non-small cell lung cancer
  • non-squamous tumors
  • squamous tumors
  • PD-L1

Additional Relevant MeSH Terms

  • Metastatic Non-small Cell Lung Cancer