RecruitingPhase 3

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

CO

CT

FL

IL

MO

MT

NC

ND

NE

NV

  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) · Reno, NV 89502Study Coordinator · Study contact · 775-982-4000More trials in Reno

NY

PA

SD

TN

VA

WI

WV