Study on Intismeran (V940) With or Without Pembrolizumab for High-Risk Stage I Non-Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07513376

This clinical trial is exploring whether a new treatment, Intismeran, alone or combined with Pembrolizumab, can help prevent high-risk Stage I non-small cell lung cancer from returning after surgery.

Patient Parameters

Program Overview

Researchers are investigating new treatments for high-risk, localized non-small cell lung cancer (NSCLC) that has been surgically removed. The study aims to find out if one or two trial treatments can help stop the cancer from coming back. The treatments being tested are Intismeran (V940/mRNA-4157), which is designed to help the immune system target the cancer, and subcutaneous Pembrolizumab (SC Pembrolizumab or MK-3475A), an immunotherapy that boosts the immune system's ability to fight cancer. The main goal is to see if these treatments can improve disease-free survival compared to a placebo in patients with completely removed high-risk Stage I NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage I non-small cell lung cancer (NSCLC) with specific high-risk features like tumor size over 2 cm or certain types of tissue invasion.
  • Have had the primary lung cancer completely removed by surgery.
  • Have not received any other treatments like chemotherapy or radiotherapy for the current lung cancer.
  • Provided a tissue sample from recent surgery and a blood sample.
  • If HIV-positive, must have well-controlled HIV on antiretroviral therapy.
  • If hepatitis B positive, must have been on antiviral therapy for at least 4 weeks with undetectable viral load.
  • If previously infected with hepatitis C, must have undetectable viral load at screening.

Exclusion Criteria

  • Diagnosed with small cell lung cancer or certain other types of lung cancer.
  • Have had significant heart problems in the past year, like heart surgery or heart attacks.
  • HIV-positive participants with a history of certain cancers like Kaposi's sarcoma.
  • Have another cancer that is progressing or needed treatment in the last 3 years.
  • Have an active autoimmune disease needing treatment in the past 2 years, except for hormone replacement.
  • Have a history of lung disease requiring steroids or currently have lung disease.
  • Have an active infection needing treatment, except those allowed by the study.
  • Have had a stem cell or organ transplant.
  • Have not fully recovered from major surgery or have ongoing surgical issues.

Locations

FACILITYZIPCITYSTATE
Billings Clinic ( Site 3255)59101BillingsMontana
NHO Revive Research Institute, LLC ( Site 3218)68506LincolnNebraska
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)89502RenoNevada
Altru Health System ( Site 3254)58201Grand ForksNorth Dakota
The University of Tennessee Medical Center ( Site 3223)37920KnoxvilleTennessee

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.