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

NCT05984277

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Metastatic Non-small Cell Lung Cancer

Interventions: Volrustomig, Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (247)

Hot Springs, Arkansas, United States
Springdale, Arkansas, United States
Long Beach, California, United States
Lone Tree, Colorado, United States
Fort Myers, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Silver Spring, Maryland, United States
Towson, Maryland, United States
Detroit, Michigan, United States
Grand Island, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
East Syracuse, New York, United States
Fresh Meadows, New York, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Horsham, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
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