2023-504923-20-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 81
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has undergone margin negative, completely resected non–small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (with nodal involvement [N2]) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
- •Has no evidence of disease before randomization.
- •Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
- •No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
- •Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
排除标准
- •Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
- •Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- •Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Active infection requiring systemic therapy.
- •HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- •Received prior neoadjuvant therapy for their current NSCLC diagnosis.
- •Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
- •Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- •Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- •Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- •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 the first dose of study medication.
结局指标
主要结局
Disease-Free Survival (DFS)
Disease-Free Survival (DFS)
次要结局
- Overall Survival (OS)
- Distant Metastasis-Free Survival (DMFS)
- Lung Cancer Specific Survival (LCSS)
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
- Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
- Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
- Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30
- Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24
- Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Nazly Shariati
Scientific
Merck Sharp & Dohme LLC
研究点 (81)
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