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ACTIVE NOT RECRUITING

NCT06077760

PHASE3

A 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

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

868

Start Date

2023-12-06

Completion Date

2035-12-21

Last Updated

2026-09-18

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

Intismeran autogene

IM injection

BIOLOGICAL

Pembrolizumab

IV infusion

OTHER

Placebo

IM injection

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.

Locations (229)

Alaska Oncology and Hematology ( Site 0039)

Anchorage, Alaska, United States

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

Tucson, Arizona, United States

YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)

Yuma, Arizona, United States

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

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian ( Site 4042)

Newport Beach, California, United States

Hoag Memorial Hospital Presbyterian ( Site 4048)

Newport Beach, California, United States

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

Orange, California, United States

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

Orange, California, United States

UCHealth Memorial Hospital-Heme Onc ( Site 0052)

Colorado Springs, Colorado, United States

George Washington University Medical Faculty Associates ( Site 4064)

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

Mayo Clinic Florida ( Site 4043)

Jacksonville, Florida, United States

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

Miami, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0014)

Orange City, Florida, United States

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

Orlando, Florida, United States

Moffitt Cancer Center ( Site 0078)

Tampa, Florida, United States

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

Marietta, Georgia, United States

Southeastern Regional Medical Center ( Site 0098)

Newnan, Georgia, United States

Beacon Cancer Care ( Site 0044)

Post Falls, Idaho, United States

Illinois Cancer Care ( Site 7003)

Peoria, Illinois, United States

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

Iowa City, Iowa, United States

Saint Elizabeth Healthcare ( Site 0092)

Edgewood, Kentucky, United States

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

Louisville, Kentucky, United States

LSU Health Baton Rouge North Clinic ( Site 4040)

Baton Rouge, Louisiana, United States

Our Lady of the Lake ( Site 4050)

Baton Rouge, Louisiana, United States

University of Michigan Clinical Trials Office ( Site 0058)

Ann Arbor, Michigan, United States

Cancer and Hematology Centers of Western Michigan ( Site 4003)

Grand Rapids, Michigan, United States

St. Vincent Frontier Cancer Center ( Site 0043)

Billings, Montana, United States

NHO Revive Research Institute, LLC ( Site 4009)

Lincoln, Nebraska, United States

Memorial Sloan Kettering - Basking Ridge ( Site 4056)

Basking Ridge, New Jersey, United States

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

Hackensack, New Jersey, United States

Memorial Sloan Kettering - Monmouth ( Site 4057)

Middletown, New Jersey, United States

Memorial Sloan Kettering - Bergen ( Site 4059)

Montvale, New Jersey, United States

Atlantic Health Morristown Medical Center ( Site 4018)

Morristown, New Jersey, United States

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

Albany, New York, United States

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

Commack, New York, United States

Memorial Sloan Kettering - Westchester ( Site 4058)

Harrison, New York, United States

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

Mineola, New York, United States

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