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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)

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

868 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2035-12-21

Brief Summary

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The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intismeran autogene + Pembrolizumab

Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Group Type EXPERIMENTAL

Intismeran autogene

Intervention Type BIOLOGICAL

IM injection

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Placebo + Pembrolizumab

Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Placebo

Intervention Type OTHER

IM injection

Interventions

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Intismeran autogene

IM injection

Intervention Type BIOLOGICAL

Pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

Placebo

IM injection

Intervention Type OTHER

Other Intervention Names

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mRNA-4157 V940 MK-3475 KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Alaska Oncology and Hematology ( Site 0039)

Anchorage, Alaska, United States

Site Status RECRUITING

The University of Arizona Cancer Center - North Campus ( Site 0071)

Tucson, Arizona, United States

Site Status RECRUITING

YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)

Yuma, Arizona, United States

Site Status COMPLETED

UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)

Los Angeles, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian ( Site 4042)

Newport Beach, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian ( Site 4048)

Newport Beach, California, United States

Site Status RECRUITING

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)

Orange, California, United States

Site Status RECRUITING

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)

Orange, California, United States

Site Status RECRUITING

UCHealth Memorial Hospital-Heme Onc ( Site 0052)

Colorado Springs, Colorado, United States

Site Status COMPLETED

Mayo Clinic Florida ( Site 4043)

Jacksonville, Florida, United States

Site Status RECRUITING

Mid Florida Hematology and Oncology Center ( Site 0014)

Orange City, Florida, United States

Site Status RECRUITING

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)

Orlando, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center ( Site 0078)

Tampa, Florida, United States

Site Status RECRUITING

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)

Marietta, Georgia, United States

Site Status COMPLETED

Southeastern Regional Medical Center ( Site 0098)

Newnan, Georgia, United States

Site Status RECRUITING

Beacon Cancer Care ( Site 0044)

Post Falls, Idaho, United States

Site Status COMPLETED

University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)

Iowa City, Iowa, United States

Site Status RECRUITING

Saint Elizabeth Healthcare ( Site 0092)

Edgewood, Kentucky, United States

Site Status RECRUITING

The University of Louisville, James Graham Brown Cancer Center ( Site 0037)

Louisville, Kentucky, United States

Site Status RECRUITING

University of Michigan Clinical Trials Office ( Site 0058)

Ann Arbor, Michigan, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan ( Site 4003)

Grand Rapids, Michigan, United States

Site Status RECRUITING

St. Vincent Frontier Cancer Center ( Site 0043)

Billings, Montana, United States

Site Status COMPLETED

NHO Revive Research Institute, LLC ( Site 4009)

Lincoln, Nebraska, United States

Site Status RECRUITING

Memorial Sloan Kettering - Basking Ridge ( Site 4056)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)

Hackensack, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering - Monmouth ( Site 4057)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering - Bergen ( Site 4059)

Montvale, New Jersey, United States

Site Status RECRUITING

Atlantic Health Morristown Medical Center ( Site 4018)

Morristown, New Jersey, United States

Site Status RECRUITING

New York Oncology Hematology, P.C. ( Site 4012)

Albany, New York, United States

Site Status RECRUITING

Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering - Westchester ( Site 4058)

Harrison, New York, United States

Site Status RECRUITING