Intismeran and Pembrolizumab for Non-Small Cell Lung Cancer

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)

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
876 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with high-risk non-small cell lung cancer that has been surgically removed. Participants will receive either one or two investigational treatments to help prevent the cancer from coming back after surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with Stage I non-small cell lung cancer.
  • I have had complete surgery to remove my lung cancer.
  • I have not received any other cancer treatments apart from surgery.
  • I can provide a tissue sample from my recent surgery.
  • I have well-controlled HIV and am on treatment.
  • I have received treatment for hepatitis B and have undetectable virus levels.
  • I have a history of hepatitis C but my virus levels are undetectable.

You may not be able to join if

  • I have been diagnosed with small cell lung cancer.
  • I have had significant heart problems in the last year.
  • I have a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
  • I have another cancer that is active or has needed treatment in the last 3 years.
  • I have an autoimmune disease that needed treatment in the last 2 years.
  • I have had pneumonia or lung disease that required steroids.
  • I have an active infection that needs systemic treatment.
  • I have not fully recovered from major surgery.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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-41…
Trial Locations
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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 …
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