2022-502752-31-00招募中4 期
Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC (KEYVIBE-006)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 38
- 主要终点
- Per protocol amendment 4, there are no primary or secondary endpoints
研究概览
简要总结
Per protocol amendment 4, there are no primary or secondary objectives
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
- •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
- •Pemetrexed-specific Criteria: Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
- •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 year
结局指标
主要结局
Per protocol amendment 4, there are no primary or secondary endpoints
Per protocol amendment 4, there are no primary or secondary endpoints
次要结局
未报告次要终点
研究者
Andrew Song
Scientific
Merck Sharp & Dohme LLC
研究点 (38)
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