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Clinical Trials in Ireland / NCT06077760
Active, not recruiting Phase 3

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

NCT06077760 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2023-12-06
Last updated
2026-09-18

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Intismeran autogenePembrolizumabPlacebo

Intismeran autogene: IM injection

Pembrolizumab: IV infusion

Placebo: IM injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (229)

FacilityCityRegionStatus
Alaska Oncology and Hematology ( Site 0039) Anchorage Alaska
The University of Arizona Cancer Center - North Campus ( Site 0071) Tucson Arizona
YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020) Yuma Arizona
UCLA Clinical & Translational Research Center (CTRC) ( Site 0059) Los Angeles California
Hoag Memorial Hospital Presbyterian ( Site 4042) Newport Beach California
Hoag Memorial Hospital Presbyterian ( Site 4048) Newport Beach California
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074) Orange California
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030) Orange California
UCHealth Memorial Hospital-Heme Onc ( Site 0052) Colorado Springs Colorado
George Washington University Medical Faculty Associates ( Site 4064) Washington D.C. District of Columbia
Mayo Clinic Florida ( Site 4043) Jacksonville Florida
Miami Cancer Institute at Baptist Health, Inc. ( Site 4047) Miami Florida
Mid Florida Hematology and Oncology Center ( Site 0014) Orange City Florida
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013) Orlando Florida
Moffitt Cancer Center ( Site 0078) Tampa Florida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012) Marietta Georgia
Southeastern Regional Medical Center ( Site 0098) Newnan Georgia
Beacon Cancer Care ( Site 0044) Post Falls Idaho
Illinois Cancer Care ( Site 7003) Peoria Illinois
University of Iowa-Holden Comprehensive Cancer Center ( Site 0062) Iowa City Iowa
Saint Elizabeth Healthcare ( Site 0092) Edgewood Kentucky
The University of Louisville, James Graham Brown Cancer Center ( Site 0037) Louisville Kentucky
LSU Health Baton Rouge North Clinic ( Site 4040) Baton Rouge Louisiana
Our Lady of the Lake ( Site 4050) Baton Rouge Louisiana
University of Michigan Clinical Trials Office ( Site 0058) Ann Arbor Michigan
Cancer and Hematology Centers of Western Michigan ( Site 4003) Grand Rapids Michigan
St. Vincent Frontier Cancer Center ( Site 0043) Billings Montana
NHO Revive Research Institute, LLC ( Site 4009) Lincoln Nebraska
Memorial Sloan Kettering - Basking Ridge ( Site 4056) Basking Ridge New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036) Hackensack New Jersey
Memorial Sloan Kettering - Monmouth ( Site 4057) Middletown New Jersey
Memorial Sloan Kettering - Bergen ( Site 4059) Montvale New Jersey
Atlantic Health Morristown Medical Center ( Site 4018) Morristown New Jersey
New York Oncology Hematology, P.C. ( Site 4012) Albany New York
Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055) Commack New York
Memorial Sloan Kettering - Westchester ( Site 4058) Harrison New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095) Mineola New York
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053) New York New York
Laura and Isaac Perlmutter Cancer Center ( Site 0010) New York New York
Icahn School of Medicine at Mount Sinai ( Site 0034) New York New York

+ 189 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06077760 on ClinicalTrials.gov ↗ ← All trials in Ireland