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NCT07221474PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

12/12/2025

Completion Date

5/6/2031

Summary

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

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Intismeran Autogene

BIOLOGICAL

Pembrolizumab

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Nab-paclitaxel

OTHER

Placebo

Interested in This Trial?

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Conditions

Squamous Non-small Cell Lung Cancer

Locations

Moffitt Cancer Center ( Site 0021)

Tampa, Florida 33612

United States

Washington University School of Medicine ( Site 0024)

St Louis, Missouri 63110

United States

Valley Health Systems - Ridgewood Campus ( Site 0010)

Paramus, New Jersey 07652

United States

New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)

Albany, New York 12206

United States

Cleveland Clinic - Ohio ( Site 0016)

Cleveland, Ohio 44195

United States

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)

Corvallis, Oregon 97330

United States

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)

Nashville, Tennessee 37203

United States

Texas Oncology - Central/South Texas ( Site 8002)

Austin, Texas 78745

United States

Virginia Cancer Specialists ( Site 0003)

Fairfax, Virginia 22031

United States

Swedish Medical Center-Swedish Cancer Institute ( Site 0023)

Seattle, Washington 98104

United States

Hospital Italiano de Buenos Aires ( Site 0200)

Ciudad Autonoma de Buenos Aires., Buenos Aires C1199ABB

Argentina

Instituto Alexander Fleming ( Site 0201)

Ciudad Autonoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

Mar del Plata, Buenos Aires B7600FZO

Argentina

Clinica Adventista Belgrano ( Site 0206)

Caba., Buenos Aires F.D. C1430EGF

Argentina

Fundacion Estudios Clinicos ( Site 0207)

Rosario, Santa Fe Province S2000DSV

Argentina

Sanatorio Parque ( Site 0203)

Rosario, Santa Fe Province S2000DSV

Argentina

Westmead Hospital ( Site 0400)

Westmead, New South Wales 2145

Australia

Princess Alexandra Hospital ( Site 0403)

Woolloongabba, Queensland 4102

Australia

One Clinical Research ( Site 0402)

Nedlands, Western Australia 6009

Australia

Centro de Estudios Clínicos SAGA ( Site 0307)

Santiago, Region M. de Santiago 7500653

Chile

FALP ( Site 0300)

Santiago, Region M. de Santiago 7500921

Chile

Bradfordhill ( Site 0301)

Santiago, Region M. de Santiago 8420383

Chile

Bradford Hill Norte ( Site 0308)

Antofagasta, 1263521

Chile

Centre Georges François Leclerc ( Site 0805)

Dijon, Cote-d Or 21000

France

Institut de Cancérologie de l'Ouest ( Site 0801)

Angers, Pays de la Loire Region 49055

France

CHU GABRIEL MONTPIED ( Site 0802)

Clermont-Ferrand, Puy-de-Dome 63001

France

Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)

Ravenna, Emilia-Romagna 48121

Italy

Ospedale San Raffaele-Oncologia Medica ( Site 1002)

Milan, 20132

Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)

Milan, 20133

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)

Roma, 00168

Italy

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)

Poznan, Greater Poland Voivodeship 60-569

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)

Warsaw, Masovian Voivodeship 02-781

Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)

Przemyśl, Podkarpackie Voivodeship 37-700

Poland

National Cancer Center ( Site 0504)

Goyang-si, Kyonggi-do 10408

South Korea

Seoul National University Bundang Hospital ( Site 0500)

Seongnam-si, Kyonggi-do 13620

South Korea

Chungbuk National University Hospital-Internal medicine ( Site 0501)

Cheongju-si, North Chungcheong 28644

South Korea

Asan Medical Center ( Site 0503)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 0502)

Seoul, 06351

South Korea

ICO L Hospitalet ( Site 1311)

Hospitalet, Barcelona 08907

Spain

Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)

Jerez de la Frontera, Cadiz 11407

Spain

Hospital Universitari Vall d''Hebron ( Site 1310)

Barcelona, 08035

Spain

Hospital Ramon y Cajal ( Site 1314)

Madrid, 28034

Spain

Hospital Clinico San Carlos... ( Site 1313)

Madrid, 28040

Spain

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)

Seville, 41009

Spain

China Medical University Hospital ( Site 0606)

Taichung, 404

Taiwan

National Cheng Kung University Hospital ( Site 0601)

Tainan, 70403

Taiwan

Mackay Memorial Hospital ( Site 0604)

Taipei, 104

Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 0600)

Taipei, 106

Taiwan

Taipei Veterans General Hospital ( Site 0602)

Taipei, 11217

Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0605)

Taoyuan, 33305

Taiwan

Hacettepe Universitesi Tıp Fakultesi ( Site 1400)

Ankara, 06230

Turkey (Türkiye)

Memorial Ankara Hastanesi ( Site 1401)

Ankara, 06520

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi ( Site 1402)

Ankara, 06800

Turkey (Türkiye)

Koç Üniversitesi Hastanesi ( Site 1403)

Istanbul, 34010

Turkey (Türkiye)