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A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
NCT07221474 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)
About this study
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.
Eligibility criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-12
Estimated completion: 2031-05-06
Last updated: 2026-04-13
Interventions
Biological: Intismeran AutogeneBiological: PembrolizumabDrug: CarboplatinDrug: PaclitaxelDrug: Nab-paclitaxelOther: Placebo
Primary outcomes
- • Progression Free Survival (PFS) (Up to ~32 months)
- • Overall Survival (OS) (Up to ~42 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: ModernaTX, Inc.
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (32)
Valley Health Systems - Ridgewood Campus ( Site 0010)Recruiting
Paramus, New Jersey, United States
Cleveland Clinic - Ohio ( Site 0016)Recruiting
Cleveland, Ohio, United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)Recruiting
Nashville, Tennessee, United States
Virginia Cancer Specialists ( Site 0003)Recruiting
Fairfax, Virginia, United States
Hospital Italiano de Buenos Aires ( Site 0200)Recruiting
Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0201)Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)Recruiting
Mar del Plata, Buenos Aires, Argentina
Clinica Adventista Belgrano ( Site 0206)Recruiting
Caba., Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos ( Site 0207)Recruiting
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 0203)Recruiting
Rosario, Santa Fe Province, Argentina
Westmead Hospital ( Site 0400)Recruiting
Westmead, New South Wales, Australia
Princess Alexandra Hospital ( Site 0403)Recruiting
Woolloongabba, Queensland, Australia
One Clinical Research ( Site 0402)Recruiting
Nedlands, Western Australia, Australia
Centro de Estudios Clínicos SAGA ( Site 0307)Recruiting
Santiago, Region M. de Santiago, Chile
FALP ( Site 0300)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0301)Recruiting
Santiago, Region M. de Santiago, Chile
Bradford Hill Norte ( Site 0308)Recruiting
Antofagasta, Chile
Centre Georges François Leclerc ( Site 0805)Recruiting
Dijon, Cote-d Or, France
Institut de Cancérologie de l'Ouest ( Site 0801)Recruiting
Angers, Pays de la Loire Region, France
CHU GABRIEL MONTPIED ( Site 0802)Recruiting
Clermont-Ferrand, Puy-de-Dome, France
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)Recruiting
Przemyśl, Podkarpackie Voivodeship, Poland
National Cancer Center ( Site 0504)Recruiting
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0500)Recruiting
Seongnam-si, Kyonggi-do, South Korea
Chungbuk National University Hospital-Internal medicine ( Site 0501)Recruiting
Cheongju-si, North Chungcheong, South Korea
Asan Medical Center ( Site 0503)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 0502)Recruiting
Seoul, South Korea
National Cheng Kung University Hospital ( Site 0601)Recruiting
Tainan, Taiwan
Mackay Memorial Hospital ( Site 0604)Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0605)Recruiting
Taoyuan District, Taiwan
Hacettepe Universitesi Tıp Fakultesi ( Site 1400)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1402)Recruiting
Ankara, Turkey (Türkiye)