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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Squamous Non-small Cell Lung Cancer

In brief

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene 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 intismeran autogene 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.

Key facts

Study ID

NCT07221474

Run by

Merck Sharp & Dohme LLC

People needed

180

Starts

2025-12-12

Expected to finish

2031-05-06

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria include, but are not limited to:
• 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

You may not qualify if…

• Exclusion Criteria include, but are not limited to:
• 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

Where it is running

• Washington University School of Medicine ( Site 0024) — St Louis, Missouri, United States (enrolling)
• Valley Health Systems - Ridgewood Campus ( Site 0010) — Paramus, New Jersey, United States (enrolling)
• New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001) — Albany, New York, United States (enrolling)
• Cleveland Clinic - Ohio ( Site 0016) — Cleveland, Ohio, United States (enrolling)
• Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025) — Corvallis, Oregon, United States (enrolling)
• Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000) — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - Central/South Texas ( Site 8002) — Austin, Texas, United States (enrolling)
• Virginia Cancer Specialists ( Site 0003) — Fairfax, Virginia, United States (enrolling)
• Swedish Medical Center-Swedish Cancer Institute ( Site 0023) — Seattle, Washington, United States (enrolling)
• Hospital Italiano de Buenos Aires ( Site 0200) — Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina (enrolling)
• Instituto Alexander Fleming ( Site 0201) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Clinica Adventista Belgrano ( Site 0206) — Caba., Buenos Aires F.D., Argentina (enrolling)
• Fundacion Estudios Clinicos ( Site 0207) — Rosario, Santa Fe Province, Argentina (enrolling)
• Sanatorio Parque ( Site 0203) — Rosario, Santa Fe Province, Argentina (enrolling)
• Westmead Hospital ( Site 0400) — Westmead, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital ( Site 0403) — Woolloongabba, Queensland, Australia (enrolling)
• One Clinical Research ( Site 0402) — Nedlands, Western Australia, Australia (enrolling)
• Centro de Estudios Clínicos SAGA ( Site 0307) — Santiago, Region M. de Santiago, Chile (enrolling)
• FALP ( Site 0300) — Santiago, Region M. de Santiago, Chile (enrolling)
• Bradfordhill ( Site 0301) — Santiago, Region M. de Santiago, Chile (enrolling)
• Bradford Hill Norte ( Site 0308) — Antofagasta, Chile (enrolling)
• Centre Georges François Leclerc ( Site 0805) — Dijon, Cote-d Or, France (enrolling)
• Institut de Cancérologie de l'Ouest ( Site 0801) — Angers, Pays de la Loire Region, France (enrolling)
• Moffitt Cancer Center ( Site 0021) — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.