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

7684A-006

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.

2022-05-03

2028-09-01

2029-09-04

Recruiting

Early phase I

784

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 784, 'type': 'ESTIMATED'}}

2024-06-07