RECRUITING

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

Description

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 Overview

Study Details

Study overview

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.

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)

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

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Anchorage

Alaska Oncology and Hematology ( Site 0039), Anchorage, Alaska, United States, 99508

Yuma

YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020), Yuma, Arizona, United States, 85364

Los Angeles

UCLA Clinical & Translational Research Center (CTRC) ( Site 0059), Los Angeles, California, United States, 90095

Orange

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074), Orange, California, United States, 92868

Orange

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030), Orange, California, United States, 92868

Colorado Springs

UCHealth Memorial Hospital-Heme Onc ( Site 0052), Colorado Springs, Colorado, United States, 80909

Orange City

Mid Florida Hematology and Oncology Center ( Site 0014), Orange City, Florida, United States, 32763

Orlando

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013), Orlando, Florida, United States, 32804

Tampa

Moffitt Cancer Center ( Site 0078), Tampa, Florida, United States, 33612

Marietta

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012), Marietta, Georgia, United States, 30060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2035-12-21