> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-adjuvant-intismeran-v940-with-or-without-fbd7991a-01c0-4994-874e-a85283837202 > Record changed: 2026-11-04 # A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014) NCT07513376 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) Participants 876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) Start date 2026-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) Number of sites 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Acronym** INTerpath-014 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Short title** A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Dates **Completion date** 2038-05-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **First posted** 2026-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Registry last updated** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Primary completion date** 2034-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Start date** 2026-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Size and sites **Participants** 876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Planned participants** 876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Number of sites** 124 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Identifiers **Registry ID** NCT07513376 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **ClinicalTrials.gov ID** NCT07513376 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masking description** Arm A - Open Label Arms B and C - Double Blind **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Outcomes ### Primary outcomes 1. 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 Timeframe: 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. ### Secondary outcomes 1. DFS as Assessed by BICR Timeframe: 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. 2. Distant Metastasis-Free Survival (DMFS) Timeframe: Up to approximately 111 months DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis by BICR or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes. 3. Overall Survival (OS) Timeframe: Up to approximately 123 months OS is defined as the time from randomization to death due to any cause. 4. Number Participants Who Experience an Adverse Events (AE) Timeframe: Up to approximately 144 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. 5. Number of Participants Who Discontinue Study Treatment Due to an AE Timeframe: Up to approximately 144 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported. 6. 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 Timeframe: Baseline and up to approximately 36 months EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100\. A higher score indicates a better outcome. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented. 7. Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score Timeframe: Baseline and up to approximately 36 months EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100\. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented. 8. Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score Timeframe: Baseline and up to approximately 36 months EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100\. A higher score indicates a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Sites - UC Davis Comprehensive Cancer Center ( Site 3204)Sacramento, United StatesRecruiting - University of Colorado Cancer Center ( Site 3268)Aurora, United StatesRecruiting - Smilow Cancer Center at Yale-New Haven ( Site 3253)New Haven, United StatesRecruiting - UF Health Cancer Center ( Site 3257)Gainesville, United StatesRecruiting - Illinois Cancer Care ( Site 7000)Peoria, United StatesRecruiting - Washington University School of Medicine ( Site 3279)St Louis, United StatesRecruiting - Billings Clinic ( Site 3255)Billings, United StatesRecruiting - NHO Revive Research Institute, LLC ( Site 3218)Lincoln, United StatesRecruiting - Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)Reno, United StatesRecruiting - New York Oncology Hematology, P.C. ( Site 9000)Albany, United StatesRecruiting - SUNY Upstate Medical University ( Site 3270)Syracuse, United StatesRecruiting - White Plains Hospital ( Site 3213)White Plains, United StatesRecruiting - Charles George VA Medical Center ( Site 3233)Asheville, United StatesRecruiting - UNC Lineberger Comprehensive Cancer Center ( Site 3250)Chapel Hill, United StatesRecruiting - WakeMed Raleigh Campus ( Site 3214)Raleigh, United StatesRecruiting - Sanford Fargo Medical Center ( Site 3236)Fargo, United StatesRecruiting - Altru Health System ( Site 3254)Grand Forks, United StatesRecruiting - Perelman Center for Advanced Medicine ( Site 3205)Philadelphia, United StatesRecruiting - Sanford Cancer Center ( Site 3266)Sioux Falls, United StatesRecruiting - Avera Cancer Institute ( Site 3209)Sioux Falls, United StatesRecruiting - The University of Tennessee Medical Center ( Site 3223)Knoxville, United StatesRecruiting - University of Texas-MD Anderson Cancer Center ( Site 3283)Houston, United StatesRecruiting - Hematology Oncology Associates of Fredericksburg ( Site 3275)Fredericksburg, United StatesRecruiting - Fred Hutchinson Cancer Center ( Site 3202)Seattle, United StatesRecruiting - West Virginia University ( Site 3237)Morgantown, United StatesRecruiting And 99 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) - Related resource (www.trialsummaries.com) Source: [www.trialsummaries.com](https://www.trialsummaries.com/Study/StudyDetails?id=27279&tenant=MT%5FMSD%5F9011) ### Other registry identifiers (5) - V940-014 - 2025 - U1111-1323-9950 - 2025-522643-18-00 - jRCT2021260028 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07513376) ## Related records ### Drugs (3) - [Berahyaluronidase alfa](https://trialight.com/data/asset/berahyaluronidase-alfa-1dda0ceb-c5c0-4aec-abf5-2bc9cdffc460.md) - [Intismeran autogene](https://trialight.com/data/asset/intismeran-autogene-4f48623c-efac-42b3-91c2-22f7c2a4bde2.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [ModernaTX, Inc.](https://trialight.com/data/company/modernatx-inc-8ece6782-e44c-4999-be6a-0b94e61dfff5.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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