Non-small Cell Lung Cancer study: Intismeran
Official 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)
ClinicalTrials.gov ID: NCT07513376
What this study is testing
What is Intismeran?
Intismeran is an investigational injectable medicine being studied as a potential treatment to prevent recurrence of high‑risk, localized non‑small cell lung cancer after surgery. Intismeran is designed to teach the immune system to recognize and attack the patient’s specific cancer cells.
Also referred to as V940, mRNA-4157.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding a new medicine to a cancer vaccine helps keep the cancer away. It compares this mix to a pretend treatment with no medicine.
- Who it's for
- You may be able to join if you have had high-risk Stage I non-small cell lung cancer removed by surgery.
- What's involved
- You would get shots of a cancer vaccine and a medicine that helps your immune system. You would also get regular check-ups to see if the cancer comes back.
- Time commitment
- The study lasts for a set time with regular visits to the clinic for shots and tests.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC)...
- 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...
- 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)
You likely can't join if
- Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor...
- Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting...
- 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.
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
See the full eligibility criteria
- 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...
- 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...
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Sacramento, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Peoria, Illinois, United States
- St Louis, Missouri, United States
- Billings, Montana, United States
- Lincoln, Nebraska, United States
- Reno, Nevada, United States
- Albany, New York, United States
- Syracuse, New York, United States
- White Plains, New York, United States
- Asheville, North Carolina, United States
- Chapel Hill, North Carolina, United States
- Raleigh, North Carolina, United States
- Fargo, North Dakota, United States
- Grand Forks, North Dakota, United States
- Philadelphia, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Knoxville, Tennessee, United States
+ 89 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sacramento, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Gainesville, Florida, United States; Peoria, Illinois, United States; St Louis, Missouri, United States and 103 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.