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Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
784 patients around the world
Available in Chile, Guatemala, Costa Rica, Brazil, Mexico
Merck Sharp & Dohme LLC
18Research sites
784Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeonHas no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brainHas measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology reviewHas not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLCHas provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study interventionHas a life expectancy of at least 6 months
- Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligibleHas received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancerHas received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study interventionIs expected to require any other form of antineoplastic therapy, while on studyHas received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study interventionHas received a live or live-attenuated vaccine within 30 days before the first dose of study interventionIs currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study interventionHas a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medicationHas a known additional malignancy that is progressing or has required active treatment within the past 5 yearsHas an active autoimmune disease that has required systemic treatment in past 2 yearsHas a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseaseHas an active infection requiring systemic therapyHas a known history of human immunodeficiency virus (HIV) infectionHas a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infectionHas had an allogenic tissue/solid organ transplantPemetrexed-specific Criteria:Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexedIs unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Sites
AC Camargo Cancer Center
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
Instituto de Educação, Pesquisa e Gestão em Saúde
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Centro de Oncología de Precisión
Recruiting
Oncocentro APYS - Valparaíso
Recruiting
James Lind Centro de Investigación del Cáncer - Temuco
Recruiting
Biocenter
Recruiting
Instituto Oncológico FALP - UIDO
Recruiting
Clínica CIMCA
Recruiting
StudyKEYVIBE-006
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05298423
