問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberV940-002
NCT Number(ClinicalTrials.gov Identfier)NCT06077760
Active

2023-11-01 - 2035-12-31

Phase III

Recruiting7

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jih-Hsiang Lee Division of Hematology & Oncology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer

Objectives

main purpose: ‧ Compare disease-free survival (DFS) of V940 plus pembrolizumab to placebo plus pembrolizumab. Secondary purpose: ‧ Compare overall survival (OS) of V940 plus pembrolizumab versus placebo plus pembrolizumab. ‧ To assess the performance of V940 plus pembrolizumab versus placebo plus pembrolizumab on trial moderator-assessed disease metastasis-free survival (DMFS). ‧ To evaluate the performance of V940 plus pembrolizumab versus placebo plus pembrolizumab in terms of lung cancer-specific survival (LCSS). ‧ To evaluate the overall health status/quality of life (QoL) of V940 plus pembrolizumab versus placebo plus pembrolizumab using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) and Lung Cancer Questionnaire 24 (EORTC QLQ-LC24) , average changes from base period in physical functioning and role functioning. ‧ To assess the safety and tolerability of V940 plus pembrolizumab.

Test Drug

V940 (mRNA-4157)KEYTRUDAR

Active Ingredient

V940（mRNA-4157）
Pembrolizumab

Dosage Form

Injection

Dosage

1 mg/mL
25 mg/mL

Endpoints

DFS: time from random assignment to any recurrence (local, locoregional, regional, or distant), development of new primary NSCLC, or death from any cause, whichever occurs first.

Inclution Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has surgically resected and histologically confirmed diagnosis of pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous NSCLC as 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

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.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    868 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB