A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
Metastatic Non-small Cell Lung CancerThe 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%.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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 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.
Study Location
Research Site
Research SiteWinnipeg, Manitoba
Canada
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Research Site
Research SiteToronto, Ontario
Canada
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Research Site
Research SiteEdmonton, Alberta
Canada
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Research Site
Research SiteOshawa, Ontario
Canada
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Research Site
Research SiteCalgary, Alberta
Canada
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Research Site
Research SiteHalifax, Nova Scotia
Canada
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Research Site
Research SiteLevis, Quebec
Canada
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Research Site
Research SiteBarrie, Ontario
Canada
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Research Site
Research SiteTrois-Rivières, Quebec
Canada
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- Study Sponsored By
- AstraZeneca
- Participants Required
- More Information
- Study ID:
NCT05984277