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Clinical Trials List

Protocol NumberV940-009
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

    Merck Sharp & Dohme

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 Division of Hematology & Oncology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC

Objectives

To compare adjuvant V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS as assessed by the investigator. Hypothesis (H1): V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Test Drug

injection

Active Ingredient

V940 (mRNA-4157)
Pembrolizumab

Dosage Form

270
270

Dosage

1 mg/mL
100 mg/4mL

Endpoints

DFS: the time from randomization to any
recurrence (local, locoregional, regional, or
distant), occurrence of new primary
NSCLC, or death due to any cause,
whichever occurs first.

Inclution Criteria

An individual is eligible for inclusion in the study if the individual meets all of the following
criteria:
Criteria 1 through 14 apply to screening for both the Neoadjuvant and Adjuvant
Phases:
Type of Participant and Disease Characteristics
1. The participant must have a histologically/cytologically confirmed diagnosis of
previously untreated (with the exception of participants enrolling after the specified
neoadjuvant treatment and surgery) and pathologically confirmed resectable Stage II,
IIIA, or IIIB (N2) NSCLC (AJCC 8th Edition) (Appendix 9).
Note: Lymph node disease requires histological or cytological confirmation if it will
affect stage grouping stratification, otherwise imaging can act as surrogate for
pathological staging.
2. Has an ECOG performance status of 0 or 1 within 7 days before the first dose of study
intervention for both study phases.
3. Be able to undergo protocol therapy, including necessary surgery as determined by the
investigator.
Note: Participants with resectable Stages II, IIIA, or IIIB (N2) NSCLC treated before
enrolling in the study with up to 4 cycles of pembrolizumab and SOC platinum-doublet
chemotherapy up to 4 cycles (or equivalent dose of platinum-doublet chemotherapy) and
had an R0 or R1 lobectomy or pneumonectomy, may enter the study if all eligibility
criteria are met.
4. Participants who have not achieved a pCR following completion of neoadjuvant
chemotherapy and pembrolizumab followed by surgery will be eligible.

Exclusion Criteria

An individual must be excluded from the study if the individual meets any of the following
criteria:
Criteria 1 through 21 apply to screening for both the Neoadjuvant and Adjuvant
Phases:
Medical Conditions
1. Diagnosis of 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.
2. Documentation by local test report indicating presence of ALK gene rearrangements.
Prior/Concomitant Therapy
3. Received prior neoadjuvant therapy for their current NSCLC diagnosis, other than what
is specified in this protocol.
4. Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an
agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-
40, CD137).
5. Received prior systemic anticancer therapy including investigational agents other than
what is specified in this protocol.
6. Received prior treatment with a cancer vaccine, including another INT.
7. Received prior radiotherapy within 2 weeks of start of study intervention, or has
radiation-related toxicities, requiring corticosteroids.
8. Received a live or live-attenuated vaccine within 30 days before the first dose of study
intervention. Administration of killed vaccines is allowed.
Refer to Section 6.5 for information on COVID-19 vaccines.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    680 participants

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