Back to search results

Study of Intismeran Autogene and Pembrolizumab for Lung Cancer

This study is looking at a new treatment for non-small cell lung cancer (NSCLC) that has been completely removed by surgery. It compares two treatments: intismeran autogene plus pembrolizumab, versus a placebo (an inactive substance) plus pembrolizumab. The goal is to see if intismeran autogene, when added to pembrolizumab, can help people live longer without their cancer returning. You may be able to join if you are 18 or older, have had surgery for Stage II, IIIA, or IIIB (with N2 nodal involvement) NSCLC, and your cancer was completely removed. The study aims to enroll 868 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two treatment approaches. It plans to enroll 868 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Disease-Free Survival (DFS) for up to approximately 78 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06077760

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~868 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Intismeran autogenePembrolizumabPlacebo

At a glance

Recruiting sites
154 of 229 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease- Free Survival (DFS)
Measured over Up to ~78 months

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

229 sites across 142 states
New York12
Taiwan6
California5
Florida5
New Jersey5
Tennessee5
Mexico5
Turkey (Türkiye)5

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
Has no evidence of disease before randomization.
Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
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.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

Exclusion

Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Received prior neoadjuvant therapy for their current NSCLC diagnosis.
Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Active infection requiring systemic therapy.

What this trial measures

  • Disease- Free Survival (DFS)Up to ~78 months

    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.