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En undersøgelse af V940/placebo + pembrolizumab og kemoterapi ved metastatisk spinocellulær lungecancer (V940-013) (INTerpath-13)

9. november 2026 opdateret af: Merck Sharp & Dohme LLC

En fase 2, randomiseret, dobbeltblind, placebokontrolleret undersøgelse af V940 i kombination med pembrolizumab og kemoterapi som første-linje behandling for deltagere med metastatisk pladecelle-NSCLC (INTerpath-013)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Planocellulær ikke-småcellet lungekræft

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Toll Free Number
Telefonnummer: 1-888-577-8839
E-mail: Trialsites@msd.com

Studiesteder

Argentina
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
    - Rekruttering
    - Instituto Alexander Fleming ( Site 0201)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +541132218956
  - Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina, C1199ABB
    - Rekruttering
    - Hospital Italiano de Buenos Aires ( Site 0200)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +541149590497
  - Mar del Plata, Buenos Aires, Argentina, B7600FZO
    - Rekruttering
    - Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +5492235937663
- Buenos Aires F.D.
  - Caba., Buenos Aires F.D., Argentina, C1430EGF
    - Rekruttering
    - Clinica Adventista Belgrano ( Site 0206)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +5491140141500
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000DSV
    - Rekruttering
    - Fundacion Estudios Clinicos ( Site 0207)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +5493413168137
  - Rosario, Santa Fe Province, Argentina, S2000DSV
    - Rekruttering
    - Sanatorio Parque ( Site 0203)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +543874044942
Australien
- New South Wales
  - Westmead, New South Wales, Australien, 2145
    - Rekruttering
    - Westmead Hospital ( Site 0400)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +61298455555
- Queensland
  - Woolloongabba, Queensland, Australien, 4102
    - Rekruttering
    - Princess Alexandra Hospital ( Site 0403)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +61731762111
- Western Australia
  - Nedlands, Western Australia, Australien, 6009
    - Rekruttering
    - One Clinical Research ( Site 0402)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +6186279 9466
Chile
- - Antofagasta, Chile, 1263521
    - Rekruttering
    - Bradford Hill Norte ( Site 0308)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 56442023631
- Region M. de Santiago
  - Santiago, Region M. de Santiago, Chile, 7500653
    - Rekruttering
    - Centro de Estudios Clínicos SAGA ( Site 0307)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +56991612199
  - Santiago, Region M. de Santiago, Chile, 8420383
    - Rekruttering
    - Bradfordhill ( Site 0301)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +56 2 29490970
  - Santiago, Region M. de Santiago, Chile, 7500921
    - Rekruttering
    - Fundación Arturo López Pérez ( Site 0300)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 56224205098
Forenede Stater
- Florida
  - Tampa, Florida, Forenede Stater, 33612
    - Rekruttering
    - Moffitt Cancer Center ( Site 0021)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 813-745-7363
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48105
    - Rekruttering
    - VA Ann Arbor Healthcare System ( Site 0019)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 734-769-7100
- Missouri
  - St Louis, Missouri, Forenede Stater, 63110
    - Rekruttering
    - Washington University School of Medicine ( Site 0024)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 314-362-5000
- New Jersey
  - Paramus, New Jersey, Forenede Stater, 07652
    - Rekruttering
    - Valley Health Systems - Ridgewood Campus ( Site 0010)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 201-634-5578
- New York
  - Albany, New York, Forenede Stater, 12206
    - Rekruttering
    - New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 518-489-0044
- Ohio
  - Cleveland, Ohio, Forenede Stater, 44195
    - Rekruttering
    - Cleveland Clinic - Ohio ( Site 0016)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 216-445-7855
- Oregon
  - Corvallis, Oregon, Forenede Stater, 97330
    - Rekruttering
    - Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 541-768-4950
- Tennessee
  - Nashville, Tennessee, Forenede Stater, 37203
    - Rekruttering
    - Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 615-961-9469
- Texas
  - Austin, Texas, Forenede Stater, 78745
    - Rekruttering
    - Texas Oncology - Central/South Texas ( Site 8002)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 512-427-9400
- Virginia
  - Fairfax, Virginia, Forenede Stater, 22031
    - Rekruttering
    - Virginia Cancer Specialists ( Site 0003)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 730-280-5390
- Washington
  - Seattle, Washington, Forenede Stater, 98104
    - Rekruttering
    - Swedish Medical Center-Swedish Cancer Institute ( Site 0023)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 855-922-6237
Frankrig
- Cote-d Or
  - Dijon, Cote-d Or, Frankrig, 21000
    - Rekruttering
    - Centre Georges François Leclerc ( Site 0805)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +33345348051
- Pays de la Loire Region
  - Angers, Pays de la Loire Region, Frankrig, 49055
    - Rekruttering
    - Institut de Cancérologie de l'Ouest ( Site 0801)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +33 (0)2.44 85 35 54
- Puy-de-Dome
  - Clermont-Ferrand, Puy-de-Dome, Frankrig, 63001
    - Rekruttering
    - CHU GABRIEL MONTPIED ( Site 0802)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +33473754440
Italien
- - Milan, Italien, 20132
    - Rekruttering
    - Ospedale San Raffaele-Oncologia Medica ( Site 1002)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +390226436633
  - Milan, Italien, 20133
    - Rekruttering
    - Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +390223903829
  - Perugia, Italien, 06132
    - Rekruttering
    - AO Santa Maria della Misericordia-Oncology Department ( Site 1005)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +390755782661
  - Roma, Italien, 00168
    - Rekruttering
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 00390630154277
- Emilia-Romagna
  - Ravenna, Emilia-Romagna, Italien, 48121
    - Rekruttering
    - Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +390544285247
Polen
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Polen, 60-569
    - Rekruttering
    - Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +48616654242
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Polen, 02-781
    - Rekruttering
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +48225463066
- Podkarpackie Voivodeship
  - Przemyśl, Podkarpackie Voivodeship, Polen, 37-700
    - Rekruttering
    - Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +48166775000
Spanien
- - Barcelona, Spanien, 08035
    - Rekruttering
    - Hospital Universitari Vall d''Hebron ( Site 1310)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +34 93 254 3450
  - Madrid, Spanien, 28034
    - Rekruttering
    - Hospital Ramon y Cajal ( Site 1314)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +34 91 336 82 63
  - Madrid, Spanien, 28040
    - Rekruttering
    - Hospital Clinico San Carlos... ( Site 1313)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +34 913303000
  - Seville, Spanien, 41009
    - Rekruttering
    - Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +34 671560092
- Barcelona
  - Hospitalet, Barcelona, Spanien, 08907
    - Rekruttering
    - ICO L Hospitalet ( Site 1311)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +34 93 260 77 44
- Cadiz
  - Jerez de la Frontera, Cadiz, Spanien, 11407
    - Rekruttering
    - Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 956 03 22 44
Sydkorea
- - Seoul, Sydkorea, 05505
    - Rekruttering
    - Asan Medical Center ( Site 0503)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +82230103215
  - Seoul, Sydkorea, 06351
    - Rekruttering
    - Samsung Medical Center ( Site 0502)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +82234101132
- Kyonggi-do
  - Goyang-si, Kyonggi-do, Sydkorea, 10408
    - Rekruttering
    - National Cancer Center ( Site 0504)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +82319200114
  - Seongnam-si, Kyonggi-do, Sydkorea, 13620
    - Rekruttering
    - Seoul National University Bundang Hospital ( Site 0500)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +82317877071
- North Chungcheong
  - Cheongju-si, North Chungcheong, Sydkorea, 28644
    - Rekruttering
    - Chungbuk National University Hospital-Internal medicine ( Site 0501)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: 043-269-6015
Taiwan
- - Taichung, Taiwan, 404
    - Rekruttering
    - China Medical University Hospital ( Site 0606)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +886422052121
  - Tainan, Taiwan, 70403
    - Rekruttering
    - National Cheng Kung University Hospital ( Site 0601)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +88662353535
  - Taipei, Taiwan, 104
    - Rekruttering
    - Mackay Memorial Hospital ( Site 0604)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +886225433535
  - Taipei, Taiwan, 11217
    - Rekruttering
    - Taipei Veterans General Hospital ( Site 0602)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +88628712121
  - Taipei, Taiwan, 106
    - Rekruttering
    - National Taiwan University Cancer Center (NTUCC) ( Site 0600)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +886223220322
  - Taoyuan, Taiwan, 33305
    - Rekruttering
    - Chang Gung Medical Foundation-Linkou Branch ( Site 0605)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +88633281200
Tyrkiet (Türkiye)
- - Ankara, Tyrkiet (Türkiye), 06230
    - Rekruttering
    - Hacettepe Universitesi Tıp Fakultesi ( Site 1400)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +905436067759
  - Ankara, Tyrkiet (Türkiye), 06800
    - Rekruttering
    - Ankara Bilkent Şehir Hastanesi ( Site 1402)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +905384724282
  - Ankara, Tyrkiet (Türkiye), 06520
    - Rekruttering
    - Memorial Ankara Hastanesi ( Site 1401)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +9005321332009
  - Istanbul, Tyrkiet (Türkiye), 34010
    - Rekruttering
    - Koç Üniversitesi Hastanesi ( Site 1403)
    - Kontakt:
      
      Study Coordinator
      
      Telefonnummer: +905369410661

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Intismeran Autogene + 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 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Intismeran Autogene 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. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.	Biologisk: Intismeran Autogene 1 mg Intramuscular (IM) Injection Andre navne: mRNA-4157 V940 Biologisk: Pembrolizumab 200 mg IV Infusion Andre navne: MK-3475 KEYTRUDA® Medicin: Carboplatin Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion Medicin: Paclitaxel 200 or 175 mg/m^2 IV Infusion Medicin: Nab-paclitaxel 100 mg/m^2 IV Infusion
Eksperimentel: 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 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with 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.	Biologisk: Pembrolizumab 200 mg IV Infusion Andre navne: MK-3475 KEYTRUDA® Medicin: Carboplatin Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion Medicin: Paclitaxel 200 or 175 mg/m^2 IV Infusion Medicin: Nab-paclitaxel 100 mg/m^2 IV Infusion Andet: Placebo Placebo matched to Intismeran Autogene IM injection

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Intismeran Autogene + 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 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Intismeran Autogene 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. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.

Biologisk: Intismeran Autogene

1 mg Intramuscular (IM) Injection

Andre navne:

mRNA-4157
V940

Biologisk: Pembrolizumab

200 mg IV Infusion

Andre navne:

MK-3475
KEYTRUDA®

Medicin: Carboplatin

Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion

Medicin: Paclitaxel

200 or 175 mg/m^2 IV Infusion

Medicin: Nab-paclitaxel

100 mg/m^2 IV Infusion

Eksperimentel: 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 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with 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.

Biologisk: Pembrolizumab

200 mg IV Infusion

Andre navne:

MK-3475
KEYTRUDA®

Medicin: Carboplatin

Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion

Medicin: Paclitaxel

200 or 175 mg/m^2 IV Infusion

Medicin: Nab-paclitaxel

100 mg/m^2 IV Infusion

Andet: Placebo

Placebo matched to Intismeran Autogene IM injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Progression Free Survival (PFS) Tidsramme: Up to ~32 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.	Up to ~32 months
Overall Survival (OS) Tidsramme: Up to ~42 months	OS, defined as the time from randomization to death due to any cause. OS will be presented.	Up to ~42 months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Response Rate (ORR) Tidsramme: Up to ~26 months	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.	Up to ~26 months
Duration of Response (DOR) Tidsramme: Up to ~42 months	For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.	Up to ~42 months
Number of Participants who Experience an Adverse Event (AE) Tidsramme: Up to ~42 months	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.	Up to ~42 months
Number of Participants who Discontinue Study Intervention Due to an AE Tidsramme: Up to ~24 months	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be presented.	Up to ~24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Samarbejdspartnere

ModernaTX, Inc.

Efterforskere

Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2025

Primær færdiggørelse (Anslået)

2. juli 2029

Studieafslutning (Anslået)

6. maj 2031

Datoer for studieregistrering

Først indsendt

24. oktober 2025

Først indsendt, der opfyldte QC-kriterier

24. oktober 2025

Først opslået (Faktiske)

28. oktober 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

V940-013
V940-013 (Anden identifikator: MSD)
U1111-1318-2495 (Registry Identifier: UTN)
2025-520902-37-00 (Registry Identifier: EU CT)
2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

En undersøgelse af V940/placebo + pembrolizumab og kemoterapi ved metastatisk spinocellulær lungecancer (V940-013) (INTerpath-13)

En fase 2, randomiseret, dobbeltblind, placebokontrolleret undersøgelse af V940 i kombination med pembrolizumab og kemoterapi som første-linje behandling for deltagere med metastatisk pladecelle-NSCLC (INTerpath-013)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt