Status:
ACTIVE_NOT_RECRUITING
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
Lead Sponsor:
AstraZeneca
Conditions:
Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be random...
Eligibility Criteria
Inclusion
- Key
- 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
- 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:
- 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.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 23 2029
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05984277
Start Date
October 24 2023
End Date
March 23 2029
Last Update
December 17 2025
Active Locations (256)
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1
Research Site
Prescott, Arizona, United States, 86301
2
Research Site
Hot Springs, Arkansas, United States, 71913
3
Research Site
Springdale, Arkansas, United States, 72762
4
Research Site
Long Beach, California, United States, 90806