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)

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

Key facts

Study ID

NCT05298423

Run by

Merck Sharp & Dohme LLC

People needed

611

Starts

2022-05-03

Expected to finish

2026-08-19

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
• Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
• Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
• Has 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 brain
• Has 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 review
• Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
• Has 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 intervention
• Has a life expectancy of at least 6 months

You may not qualify if…

• Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
• Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
• Has 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 intervention
• Is expected to require any other form of antineoplastic therapy, while on study
• Has 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 intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Is 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 intervention
• Has 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 medication
• Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has 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) infection
• Has had an allogenic tissue/solid organ transplant
• Pemetrexed-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 pemetrexed
• Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Where it is running

• VA West Los Angeles Medical Center ( Site 2808) — Los Angeles, California, United States
• Millennium Oncology Research Clinic ( Site 2801) — Hollywood, Florida, United States
• Mid Florida Hematology and Oncology Center ( Site 2800) — Orange City, Florida, United States
• Moffitt Cancer Center ( Site 2818) — Tampa, Florida, United States
• University of Chicago Medical Center ( Site 2828) — Chicago, Illinois, United States
• Franciscan St. Francis Health ( Site 2812) — Indianapolis, Indiana, United States
• MFSMC-HJWCI ( Site 2804) — Baltimore, Maryland, United States
• Boston Medical Center ( Site 2829) — Boston, Massachusetts, United States
• University of Massachusetts Chan Medical School ( Site 2815) — Worcester, Massachusetts, United States
• University of Missouri Hospital ( Site 2839) — Columbia, Missouri, United States
• Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837) — Springfield, Missouri, United States
• Rutgers Cancer Institute of New Jersey ( Site 2805) — New Brunswick, New Jersey, United States
• Icahn School of Medicine at Mount Sinai ( Site 2821) — New York, New York, United States
• White Plains Hospital ( Site 2835) — White Plains, New York, United States
• Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816) — Portland, Oregon, United States
• Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827) — Lancaster, Pennsylvania, United States
• Thomas Jefferson University - Clinical Research Institute ( Site 2813) — Philadelphia, Pennsylvania, United States
• Millennium Research & Clinical Development ( Site 2811) — Houston, Texas, United States
• Central Texas Veterans health care-Oncology & Hematology ( Site 2819) — Temple, Texas, United States
• MultiCare Health System ( Site 2817) — Tacoma, Washington, United States
• Clinica Adventista Belgrano ( Site 3601) — Caba., Buenos Aires F.D., Argentina
• Instituto Médico Río Cuarto ( Site 3600) — Río Cuarto, Córdoba Province, Argentina
• Sanatorio Parque ( Site 3602) — Rosario, Santa Fe Province, Argentina
• Canberra Hospital ( Site 0010) — Canberra, Australian Capital Territory, Australia
• VA Long Beach Healthcare System ( Site 2831) — Long Beach, California, United States

Full record on ClinicalTrials.gov

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