Recruiting

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06077760

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intismeran autogene

Pembrolizumab

Placebo

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06077760

Start date

Dec 6, 2023

Status verified date

Aug, 2026

Completion date

Dec 21, 2035

Anticipated

Primary completion date

Jun 25, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

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:

The main exclusion criteria include but are not limited to the following:

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.

Study Design

Enrollment

868 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Intismeran autogene

IM injection

Pembrolizumab

IV infusion

Placebo

IM injection

Primary outcome measure

Disease- Free Survival (DFS) [ Time Frame: Up to ~78 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Alaska Oncology and Hematology ( Site 0039)

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Study Coordinator

907-257-9851

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

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Study Coordinator

520-694-2873

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

Recruiting

Los Angeles, California, United States, 90095

Contacts

Study Coordinator

310-267-9099

Hoag Memorial Hospital Presbyterian ( Site 4042)

Recruiting

Newport Beach, California, United States, 92663

Contacts

Study Coordinator

949-764-4060

Hoag Memorial Hospital Presbyterian ( Site 4048)

Recruiting

Newport Beach, California, United States, 92663

Contacts

Study Coordinator

949-764-4060

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

Recruiting

Orange, California, United States, 92868

Contacts

Study Coordinator

714-541-6622

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

Recruiting

Orange, California, United States, 92868

Contacts

Study Coordinator

818-426-7690

George Washington University Medical Faculty Associates ( Site 4064)

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Study Coordinator

202-741-2210

Mayo Clinic Florida ( Site 4043)

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Study Coordinator

855-776-0015

Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)

Recruiting

Miami, Florida, United States, 33176

Contacts

Study Coordinator

786-596-2000

Mid Florida Hematology and Oncology Center ( Site 0014)

Recruiting

Orange City, Florida, United States, 32763

Contacts

Study Coordinator

386-538-3169

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

Recruiting

Orlando, Florida, United States, 32804

Contacts

Study Coordinator

407-303-2024

Moffitt Cancer Center ( Site 0078)

Recruiting

Tampa, Florida, United States, 33612

Contacts

Study Coordinator

813-580-7073

Southeastern Regional Medical Center ( Site 0098)

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Study Coordinator

770-400-6305

Illinois Cancer Care ( Site 7003)

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Study Coordinator

309-243-3605

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

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Study Coordinator

319-356-1616

Saint Elizabeth Healthcare ( Site 0092)

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Study Coordinator

859-301-4737

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

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Study Coordinator

502-562-3919

LSU Health Baton Rouge North Clinic ( Site 4040)

Recruiting

Baton Rouge, Louisiana, United States, 70805

Contacts

Study Coordinator

225-358-2312

Our Lady of the Lake RMC-Clinical Research ( Site 4050)

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Study Coordinator

225-358-2312

University of Michigan Clinical Trials Office ( Site 0058)

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Study Coordinator

800-865-1125

Cancer and Hematology Centers of Western Michigan ( Site 4003)

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-954-9800

NHO Revive Research Institute, LLC ( Site 4009)

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

Study Coordinator

284-564-1485

Memorial Sloan Kettering - Basking Ridge ( Site 4056)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Study Coordinator

646-888-4409

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5855

Memorial Sloan Kettering - Monmouth ( Site 4057)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Study Coordinator

646-888-4409

Memorial Sloan Kettering - Bergen ( Site 4059)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Study Coordinator

646-888-4409

Atlantic Health Morristown Medical Center ( Site 4018)

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Study Coordinator

973-971-6283

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

Recruiting

Albany, New York, United States, 12206

Contacts

Study Coordinator

518-489-0044

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

Recruiting

Commack, New York, United States, 11725

Contacts

Study Coordinator

646-888-4409

Memorial Sloan Kettering - Westchester ( Site 4058)

Recruiting

Harrison, New York, United States, 10604

Contacts

Study Coordinator

646-888-4409

Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)

Recruiting

Mineola, New York, United States, 11501

Contacts

Study Coordinator

409-543-5553

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)

Recruiting

New York, New York, United States, 10011

Contacts

Study Coordinator

888-577-8839

Laura and Isaac Perlmutter Cancer Center ( Site 0010)

Recruiting

New York, New York, United States, 10016

Contacts

Study Coordinator

409-543-5553

Icahn School of Medicine at Mount Sinai ( Site 0034)

Recruiting

New York, New York, United States, 10029

Contacts

Study Coordinator

888-577-8839

Memorial Sloan Kettering Cancer Center ( Site 0029)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

212-639-2000

Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)

Recruiting

The Bronx, New York, United States, 10461

Contacts

Study Coordinator

718-405-8404

Memorial Sloan Kettering - Nassau ( Site 4060)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Study Coordinator

646-888-4409

Novant Health Weisiger Cancer Insititute ( Site 4052)

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

980-302-6000

Novant Health Oncology Specialists ( Site 4045)

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Study Coordinator

336-277-8800

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Study Coordinator

701-234-6161

Altru Health System ( Site 0040)

Recruiting

Grand Forks, North Dakota, United States, 58201

Contacts

Study Coordinator

701-780-5400

University Hospitals Cleveland Medical Center ( Site 0023)

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Study Coordinator

800-641-2422

OSU Brain and Spine Hospital ( Site 0016)

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Study Coordinator

614-366-6174

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Study Coordinator

541-768-7169

Thomas Jefferson University - Clinical Research Institute ( Site 0006)

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Study Coordinator

215-600-9151

Medical University of South Carolina-Hollings Cancer Center ( Site 0050)

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Study Coordinator

843-792-9300

Greco-Hainsworth Centers for Research ( Site 4034)

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Study Coordinator

423-698-1844

Thompson Cancer Survival Center ( Site 0097)

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Study Coordinator

865-331-1812

Baptist Cancer Center ( Site 4049)

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Study Coordinator

901-226-1485

One Oncology - Tennessee Oncology ( Site 4019)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

731-267-3491

SCRI Oncology Partners ( Site 7001)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7640

UT Southwestern Medical Center ( Site 0061)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Coordinator

214-648-3111

Inova Schar Cancer Institute ( Site 0003)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-4724

Virginia Cancer Specialists (VCS) ( Site 4004)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

730-280-5390

Swedish Medical Center-Swedish Cancer Institute ( Site 0088)

Recruiting

Seattle, Washington, United States, 98104

Contacts

Study Coordinator

206-386-2323

Fred Hutchinson Cancer Center ( Site 0002)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-606-4801

Edwards Comprehensive Cancer Center ( Site 4015)

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Study Coordinator

304-399-6521

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-21.