A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)

NCT ID: NCT07221474

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2031-05-06

Brief Summary

Researchers want to know if V940 (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). V940 is designed to help a person's immune system attack their specific cancer.

The goal of this study is to learn if people who receive V940 with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Conditions

Squamous Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

V940 + Pembrolizumab + Chemo

Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). V940 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses.

Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. V940 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.

Group Type: EXPERIMENTAL

V940

Intervention Type: BIOLOGICAL

1 mg Intramuscular (IM) Injection

Pembrolizumab

Intervention Type: BIOLOGICAL

200 mg IV Infusion

Carboplatin

Intervention Type: DRUG

Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion

Paclitaxel

Intervention Type: DRUG

200 mg/m\^2 IV Infusion

Nab-paclitaxel

Intervention Type: DRUG

100 mg/m\^2 IV Infusion

Placebo + Pembrolizumab + Chemo

Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses.

Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

200 mg IV Infusion

Carboplatin

Intervention Type: DRUG

Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion

Paclitaxel

Intervention Type: DRUG

200 mg/m\^2 IV Infusion

Nab-paclitaxel

Intervention Type: DRUG

100 mg/m\^2 IV Infusion

Placebo

Intervention Type: OTHER

Placebo matched to V940 IM injection

Interventions

V940

1 mg Intramuscular (IM) Injection

Intervention Type: BIOLOGICAL

Pembrolizumab

200 mg IV Infusion

Intervention Type: BIOLOGICAL

Carboplatin

Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion

Intervention Type: DRUG

Paclitaxel

200 mg/m\^2 IV Infusion

Intervention Type: DRUG

Nab-paclitaxel

100 mg/m\^2 IV Infusion

Intervention Type: DRUG

Placebo

Placebo matched to V940 IM injection

Intervention Type: OTHER

Other Intervention Names

mRNA-4157; Intismeran Autogene; MK-3475; KEYTRUDA®

Eligibility Criteria

Inclusion Criteria

• Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
• Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
• 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
• Adverse events (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
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• 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
• 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
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
• Has a life expectancy of at least 3 months
• Has adequate organ function

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

One Clinical Research ( Site 0402)

Nedlands, Western Australia, Australia

Site Status: RECRUITING

National Cheng Kung University Hospital ( Site 0601)

Tainan, , Taiwan

Site Status: RECRUITING

Countries

Australia; Taiwan

Central Contacts

Toll Free Number

Role: CONTACT

Trialsites@msd.com

1-888-577-8839

Facility Contacts

Study Coordinator

Role: primary

+6186279 9466

Study Coordinator

Role: primary

+88662353535

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

V940-013

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1318-2495

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-520902-37-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

V940-013

Identifier Type: -

Identifier Source: org_study_id