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A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867) (MK 3475-867)

This Phase 3 study is to compare the Event Free Survival (EFS) of using SBRT in combination with pembrolizumab and compared to SBRT in combination with placebo. To compare Overall Survival (OS) of using SBRT in combination pembrolizumab and compared to SBRT in combination with placebo.

You will need to participate in a screening process. Then if you are selected for this study, you will need to come to all scheduled study visits where you will either receive pembrolizumab or placebo by IV for about 17 treatments. You will also have study questionnaires to complete at those study visits.

You will receive $50 per visit for your participation in this research study.

Patrick Ma
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03924869
STUDY00014801
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Inclusion Criteria:
Has an ECOG Performance Status of 0, 1, or 2.
Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA NSCLC (AJCC 8th edition) by chest CT and PET scan.
Cannot undergo thoracic surgery due to existing medical illness(es)
A female is eligible to participate if she is not pregnant and not breastfeeding
Is male or female ≥18 years of age
Exclusion Criteria:
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
Has received a live vaccine within 30 days prior to the first dose of study drug.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Cancer
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See this study on ClinicalTrials.gov
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Study Locations

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Location Contacts
Hershey, PA ,