Study

Overview

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)

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

868

Study Start Date:

December 2023

Estimated Study Completion Date:

December 2035

Estimated Primary Completion Date:

June 2030

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

CRITERIA

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

United States Toll Free Number 1-800-770-4674

Anchorage, Alaska, 99508
Tucson, Arizona, 85719
Los Angeles, California, 90095
Newport Beach, California, 92663
Newport Beach, California, 92663
Orange, California, 92868
Orange, California, 92868
Washington, District of Columbia, 20037
Jacksonville, Florida, 32224
Miami, Florida, 33176
Orange City, Florida, 32763
Orlando, Florida, 32804
Tampa, Florida, 33612
Newnan, Georgia, 30265
Peoria, Illinois, 61615
Iowa City, Iowa, 52242
Edgewood, Kentucky, 41017
Louisville, Kentucky, 40202
Baton Rouge, Louisiana, 70805
Baton Rouge, Louisiana, 70808
Ann Arbor, Michigan, 48109
Grand Rapids, Michigan, 49503
Lincoln, Nebraska, 68506
Basking Ridge, New Jersey, 07920
Hackensack, New Jersey, 07601
Middletown, New Jersey, 07748
Montvale, New Jersey, 07645
Morristown, New Jersey, 07960
Albany, New York, 12206
Bronx, New York, 10461
Commack, New York, 11725
Mineola, New York, 11501
New York, New York, 10011
New York, New York, 10016
New York, New York, 10029
New York, New York, 10065
Uniondale, New York, 11553
West Harrison, New York, 10604
Charlotte, North Carolina, 28204
Winston-Salem, North Carolina, 27103
Fargo, North Dakota, 58102
Grand Forks, North Dakota, 58201
Cleveland, Ohio, 44106
Columbus, Ohio, 43210
Corvallis, Oregon, 97330
Philadelphia, Pennsylvania, 19107
Charleston, South Carolina, 29425
Chattanooga, Tennessee, 37421
Knoxville, Tennessee, 37916
Memphis, Tennessee, 38120
Nashville, Tennessee, 37203
Nashville, Tennessee, 37203
Dallas, Texas, 75390
Fairfax, Virginia, 22031
Fairfax, Virginia, 22031
Seattle, Washington, 98104
Seattle, Washington, 98109
Huntington, West Virginia, 25701

Canada Study Coordinator 514-934-1934

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results