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Clinical Trials/2023-504923-20-00
2023-504923-20-00
Recruiting
Phase 3

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)

Merck Sharp & Dohme LLC81 sites in 12 countries420 target enrollmentStarted: March 22, 2024Last updated:
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Overview

Phase
Phase 3
Status
Recruiting
Enrollment
420
Locations
81
Primary Endpoint
Disease-Free Survival (DFS)
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Has undergone margin negative, completely resected non–small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (with nodal involvement [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

  • •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.
  • •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.
  • •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.

Outcomes

Primary Outcomes

Disease-Free Survival (DFS)

Disease-Free Survival (DFS)

Secondary Outcomes

  • Overall Survival (OS)
  • Distant Metastasis-Free Survival (DMFS)
  • Lung Cancer Specific Survival (LCSS)
  • Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
  • Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
  • Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
  • Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30
  • Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24
  • Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24
  • Number of Participants Who Experience an Adverse Event (AE)
  • Number of Participants Who Discontinue Study Treatment Due to an AE

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Nazly Shariati

Scientific

Merck Sharp & Dohme LLC

Study Sites (81)

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