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)
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for people with high-risk Stage I non-small cell lung cancer that was fully removed by surgery. It tests intismeran (V940) alone or with pembrolizumab and berahyaluronidase alfa against a placebo, a treatment with no active medicine. Researchers want to see if these treatments help people stay free of cancer longer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Stage I non-small cell lung cancer confirmed by a tissue test, with a tumor no larger than 4 cm.
- Have at least one high-risk feature: a tumor larger than 2 cm, cancer in the lung’s outer lining or blood or lymph vessels, or cancer cells that look very abnormal.
- Have had surgery to fully remove the lung cancer.
- Have had no treatment other than surgery for this lung cancer.
- Provide a tissue sample from the recent surgery and the required blood sample.
- If you have HIV, it must be well controlled with HIV medicines.
- If you test positive for hepatitis B surface antigen, you must have taken antiviral medicine for at least 4 weeks, with no virus detected before treatment groups are assigned.
- If you have had hepatitis C, no virus can be detected at screening.
Who can't join
- Have small cell lung cancer, a tumor with small cell parts, a large-cell neuroendocrine tumor, sarcomatoid cancer, or two separate non-small cell lung cancers at the same time.
- Have had serious heart or blood vessel disease in the past 12 months, such as a heart attack, stroke, severe heart failure, or certain heart procedures.
- Have HIV and a history of Kaposi’s sarcoma, a cancer, or multicentric Castleman’s disease, which affects lymph nodes.
- Have another cancer that is growing or has needed treatment in the past 3 years.
- Have an autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 2 years. Hormone replacement, such as insulin or thyroid medicine, is allowed.
- Have lung inflammation or lung tissue disease now, or had it without an infection and needed steroids to treat it.
- Have an active infection needing whole-body treatment, unless the study allows it.
- Have had a stem cell or organ transplant, or have not recovered well from major surgery or still have surgery-related problems.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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: 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
Study sites (24)
CA
- UC Davis Comprehensive Cancer Center ( Site 3204) · Sacramento, CA 95817Study Coordinator · Study contact · 916-734-5959More trials in Sacramento
CO
- University of Colorado Cancer Center ( Site 3268) · Aurora, CO 80045Study Coordinator · Study contact · 720-848-0300More trials in Aurora
CT
- Smilow Cancer Center at Yale-New Haven ( Site 3253) · New Haven, CT 06511Study Coordinator · Study contact · 203-688-4242More trials in New Haven
FL
- UF Health Cancer Center ( Site 3257) · Gainesville, FL 32610Study Coordinator · Study contact · 352-273-8010More trials in Gainesville
IL
- Illinois Cancer Care ( Site 7000) · Peoria, IL 61615Study Coordinator · Study contact · 309-240-6040More trials in Peoria
MO
- Washington University School of Medicine ( Site 3279) · St Louis, MO 63110Study Coordinator · Study contact · 314-362-5000More trials in St Louis
MT
- Billings Clinic ( Site 3255) · Billings, MT 59101Study Coordinator · Study contact · 406-435-7480More trials in Billings
NC
- Charles George VA Medical Center ( Site 3233) · Asheville, NC 28805Study Coordinator · Study contact · 828-298-7911More trials in Asheville
- UNC Lineberger Comprehensive Cancer Center ( Site 3250) · Chapel Hill, NC 27514Study Coordinator · Study contact · 919-966-4432More trials in Chapel Hill
- WakeMed Raleigh Campus ( Site 3214) · Raleigh, NC 27610Study Coordinator · Study contact · 919-350-2873More trials in Raleigh
ND
- Sanford Fargo Medical Center ( Site 3236) · Fargo, ND 58102Study Coordinator · Study contact · 701-234-7563More trials in Fargo
- Altru Health System ( Site 3254) · Grand Forks, ND 58201Study Coordinator · Study contact · 701-780-5400More trials in Grand Forks
NE
- NHO Revive Research Institute, LLC ( Site 3218) · Lincoln, NE 68506Study Coordinator · Study contact · 402-484-4900More trials in Lincoln
NV
- Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) · Reno, NV 89502Study Coordinator · Study contact · 775-982-4000More trials in Reno
NY
- New York Oncology Hematology, P.C. ( Site 9000) · Albany, NY 12206Study Coordinator · Study contact · 518-489-0044More trials in Albany
- SUNY Upstate Medical University ( Site 3270) · Syracuse, NY 13210Study Coordinator · Study contact · 315-464-8237More trials in Syracuse
- White Plains Hospital ( Site 3213) · White Plains, NY 10601Study Coordinator · Study contact · 914-849-7500More trials in White Plains
PA
- Perelman Center for Advanced Medicine ( Site 3205) · Philadelphia, PA 19104Study Coordinator · Study contact · 267-275-3770More trials in Philadelphia
SD
- Sanford Cancer Center ( Site 3266) · Sioux Falls, SD 57104Study Coordinator · Study contact · 605-312-3250More trials in Sioux Falls
- Avera Cancer Institute ( Site 3209) · Sioux Falls, SD 57105Study Coordinator · Study contact · 605-322-3000More trials in Sioux Falls
TN
- The University of Tennessee Medical Center ( Site 3223) · Knoxville, TN 37920Study Coordinator · Study contact · 865-305-8780More trials in Knoxville
VA
- Hematology Oncology Associates of Fredericksburg ( Site 3275) · Fredericksburg, VA 22408Study Coordinator · Study contact · 540-371-0079More trials in Fredericksburg
WI
- Gundersen Health System ( Site 3200) · La Crosse, WI 54601Study Coordinator · Study contact · 608-775-2385More trials in La Crosse
WV
- West Virginia University ( Site 3237) · Morgantown, WV 26506Study Coordinator · Study contact · 304-598-4500More trials in Morgantown