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Clinical Trials List

Protocol NumberV940-014
NCT Number(ClinicalTrials.gov Identfier)NCT07513376
Active

2026-03-01 - 2041-12-31

Phase III

Recruiting5

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)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Yen Tu Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer

Objectives

主要目的： (1)針對非鱗狀NSCLC，比較intismeran併用MK-3475A與安慰劑之由盲性獨立中央審查（BICR）評估的無疾病存活期（DFS）。

Test Drug

注射劑
注射劑

Active Ingredient

Intismeran (V940)
Pembrolizumab and Berahyaluronidase alfa

Dosage Form

270
270

Dosage

1 mg/mL
165 mg/ml 2.4 mL/vial 1 vial/kit

Endpoints

DFS：從隨機分配至任何復發（局部、局部區域性、區域性或遠端）或因任何原因死亡的時間，以先發生者為準。

Inclution Criteria

Inclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:

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

The Estimated Number of Participants

  • Taiwan

    38 participants

  • Global

    876 participants

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