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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)

NCT05298423

Active Not RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: pembrolizumab/vibostolimab, durvalumab, cisplatin, pemetrexed, etoposide

Countries: United States, Argentina, Australia, Brazil, Chile, China, Costa Rica, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Locations (160)

Long Beach, California, United States
Los Angeles, California, United States
Hollywood, Florida, United States
Orange City, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Columbia, Missouri, United States
Springfield, Missouri, United States
New Brunswick, New Jersey, United States
New York, New York, United States
White Plains, New York, United States
Portland, Oregon, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Temple, Texas, United States
Tacoma, Washington, United States
Caba., Buenos Aires F.D., Argentina
Río Cuarto, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Canberra, Australian Capital Territory, Australia
Hobart, Tasmania, Australia
Ballarat Central, Victoria, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Porto Alegre, Rio Grande do Sul, Brazil
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