A clinical study of V940 and pembrolizumab to treat lung cancer (V940-009)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 May 2025 → ongoing

Decision date (initial)

2024-11-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Moderna · Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-506327-29-00

WHO UTN

U1111-1293-5814

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Pharmacoeconomic, Pharmacogenetic, Pharmacogenomic, Pharmacodynamic, Pharmacokinetic, Efficacy

1. To compare adjuvant V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS as assessed by the investigator.

Secondary objectives 6

1. To compare adjuvant V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS.
2. To evaluate adjuvant V940 plus pembrolizumab and placebo plus pembrolizumab with respect to DMFS as assessed by the investigator.
3. To evaluate adjuvant V940 plus pembrolizumab and placebo plus pembrolizumab with respect to DFS2 as assessed by the investigator.
4. To evaluate adjuvant V940 plus pembrolizumab and placebo plus pembrolizumab with respect to LCSS as assessed by the investigator.
5. To evaluate adjuvant V940 plus pembrolizumab and placebo plus pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30 and EORTC QLQ-LC24.
6. To evaluate the safety and tolerability of adjuvant V940 plus pembrolizumab.

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
3. Participants who have not achieved a pCR following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
4. Confirmation that EGFR-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R])
5. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
6. 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
7. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion criteria 8

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
3. Received prior neoadjuvant therapy for their current NSCLC diagnosis
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
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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease- Free Survival (DFS)

Secondary endpoints 9

1. Overall survival (OS)
2. Distant Metastasis-Free Survival (DMFS)
3. Disease- Free Survival 2 (DFS2)
4. Lung Cancer Specific Survival (LCSS)
5. 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)
6. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)
7. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)
8. Number of participants with ≥1 adverse event (AE)
9. Number of participants discontinuing from study therapy due to AE(s)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Auxiliary 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Keller, Steven M.

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Keller, Steven M.

Third parties 9

Locations

14 EU/EEA countries · 83 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 129 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications