A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 876
- 试验地点
- 89
- 主要终点
- Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C
研究概览
简要总结
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.
People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer.
The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Arm A - Open Label Arms B and C - Double Blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size >2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
- •Has undergone a complete surgical resection of the primary NSCLC
- •Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC
- •Has provided a tissue sample from recent surgery along with the required blood sample
- •Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- •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
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
- •Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia
- •HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- •Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has active infection requiring systemic therapy other than those permitted in protocol
- •Has history of stem cell/solid organ transplant
- •Participants who have not adequately recovered from major surgery or have ongoing surgical complications
研究组 & 干预措施
Arm C: Placebo
Participants will receive dose-matched placebo via IM injection.
干预措施: Placebo (Other)
Arm B: Intismeran
Participants will receive intismeran 1 mg via IM injection.
干预措施: Intismeran (Biological)
Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa
Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.
干预措施: Intismeran (Biological)
Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa
Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.
干预措施: Pembrolizumab coformulated with berahyaluronidase alfa (Biological)
结局指标
主要结局
Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C
时间窗: Up to approximately 98 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
次要结局
- DFS as Assessed by BICR(Up to approximately 98 months)
- Distant Metastasis-Free Survival (DMFS)(Up to approximately 111 months)
- Overall Survival (OS)(Up to approximately 123 months)
- Number Participants Who Experience an Adverse Events (AE)(Up to approximately 144 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 144 months)
- Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score(Baseline and up to approximately 36 months)
- Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score(Baseline and up to approximately 36 months)
- Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score(Baseline and up to approximately 36 months)