Study

Overview

Official Title: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK-7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: -progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. -overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

784

Study Start Date:

May 2022

Estimated Study Completion Date:

September 2029

Estimated Primary Completion Date:

September 2028

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

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

United States Toll Free Number 1-800-770-4674

Long Beach, California, 90822
Los Angeles, California, 90073
Hollywood, Florida, 33024
Orange City, Florida, 32763
Chicago, Illinois, 60637
Indianapolis, Indiana, 46237
Baltimore, Maryland, 21237
Boston, Massachusetts, 02118
Worcester, Massachusetts, 01655
Springfield, Missouri, 65807
New Brunswick, New Jersey, 08903
NEW YORK, New York, 10029
White Plains, New York, 10601
Portland, Oregon, 97227
Lancaster, Pennsylvania, 17601
Philadelphia, Pennsylvania, 19107
Houston, Texas, 77090
Tacoma, Washington, 98405

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary – MK-7684A-006

Study Detail

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)