A clinical study of V940 in people with non-small cell lung cancer (V940-013)

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

1 Apr 2026 → ongoing

Decision date (initial)

2026-03-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC · Moderna Therapeutics Inc.

External identifiers

EU CT number

2025-520902-37-00

WHO UTN

U1111-1318-2495

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

1. To compare V940 versus placebo when combined with pembrolizumab and platinum chemotherapy with respect to progression-free survival (PFS) (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review (BICR)

2. To compare V940 versus placebo when combined with pembrolizumab and platinum chemotherapy with respect to overall survival (OS)

Secondary objectives 3

1. To compare V940 versus placebo when combined with pembrolizumab and platinum chemotherapy with respect to objective response rate (ORR) (as per RECIST1.1, as assessed by BICR)
2. To evaluate V940 or placebo when combined with pembrolizumab and platinum chemotherapy with respect to duration of response (DOR) (as per RECIST 1.1, as assessed by BICR)
3. To evaluate the safety and tolerability of V940 versus placebo when combined with pembrolizumab and platinum chemotherapy

Conditions and MedDRA coding

Non-small cell lung cancer stage IV

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. The participant must have a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, American Joint Committee on Cancer (AJCC) Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
2. Is of any sex/gender, from 18 years at the time of providing the informed consent.
3. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
4. Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
5. Have AEs due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
6. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
7. Hepatitis B surface antigen (HBsAg) positive participants 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
8. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
9. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
10. Has a life expectancy of at least 3 months
11. Has adequate organ function

Exclusion criteria 17

1. Is a HIV-infected participant with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
2. Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
3. Has received prior systemic anticancer therapy for their metastatic NSCLC
4. Has received prior therapy with an anti-programmed cell death 1 protein (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. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
5. Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
6. Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
7. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
8. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
9. Has a 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 intervention
10. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
12. Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
13. Has active autoimmune disease that has required systemic treatment in the past 2 years
14. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
15. Has active infection requiring systemic therapy
16. Has a history of stem cell/solid organ transplant
17. Has not adequately recovered from major surgery or have ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Progression-free survival (PFS)
2. Overall survival (OS)

Secondary endpoints 4

1. Objective response rate (ORR)
2. Duration of response (DOR)
3. Number of Participants With ≥1 Adverse Event (AE)
4. Number of Participants Discontinuing From Study Therapy Due to an AE

Investigational products

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

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Niyati Bhagwati​

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Niyati Bhagwati​

Third parties 13

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 31 files

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

Application history

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