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Clinical Trials List

Protocol NumberV940-009
NCT Number(ClinicalTrials.gov Identfier)NCT06623422
Active

2024-09-01 - 2038-12-31

Phase III

Recruiting9

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 Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/22

Investigators and Locations

Principal Investigator Chih-Yen Tu Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭小湘 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

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 Ping-Chih Hsu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu 無
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇健 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Non-Small-Cell Lung

Objectives

Primary Objective: To compare adjuvant V940 plus pembrolizumab versus placebo plus pembrolizumab based on disease-free survival (DFS) as assessed by the trial administrator. Secondary Objectives: • To compare overall survival (OS) with adjuvant V940 plus pembrolizumab versus placebo plus pembrolizumab based on distant metastasis-free survival (DMFS) as assessed by the trial administrator. • To evaluate adjuvant V940 plus pembrolizumab versus placebo plus pembrolizumab based on disease-free survival (DFS2) as assessed by the trial administrator. • To evaluate adjuvant V940 plus pembrolizumab versus placebo plus pembrolizumab based on lung cancer-specific survival (LCSS) as assessed by the trial administrator. • Assess the mean changes since baseline in overall health status/quality of life (QoL), physical functioning, and role functioning, using the European Organization for Research on Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Lung Cancer Questionnaire 24 (EORTC QLQ-LC24). • Assess the safety and tolerability of adjunctive V940 plus pembrolizumab.

Test Drug

注射劑
注射劑

Active Ingredient

V940 (mRNA-4157)
Pembrolizumab

Dosage Form

270
270

Dosage

1 mg/mL
100 mg/4mL

Endpoints

DFS: The time from random assignment to any recurrence (local, local-regional, regional, or distal), the occurrence of a new primary NSCLC, or death from any cause, whichever comes first.

Inclution Criteria

Inclusion Criteria:

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

Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R])
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
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

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, or a pancoast tumor
Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
Received prior neoadjuvant therapy for their current NSCLC diagnosis
Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137)
Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
Received prior treatment with a cancer vaccine
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    680 participants

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