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

Conditions

Metastatic Non-small Cell Lung Cancer

Study Overview

Study Details

Study overview

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%.

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).

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

Condition
Metastatic Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Prescott

Research Site, Prescott, Arizona, United States, 86301

Hot Springs National Park

Research Site, Hot Springs National Park, Arkansas, United States, 71913

Springdale

Research Site, Springdale, Arkansas, United States, 72762

Palo Alto

Research Site, Palo Alto, California, United States, 94304

Lone Tree

Research Site, Lone Tree, Colorado, United States, 80124

Newark

Research Site, Newark, Delaware, United States, 19713

Fort Myers

Research Site, Fort Myers, Florida, United States, 33901

Orlando

Research Site, Orlando, Florida, United States, 32827

Saint Petersburg

Research Site, Saint Petersburg, Florida, United States, 33705

Tallahassee

Research Site, Tallahassee, Florida, United States, 32308

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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 whole 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2029-05-16