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Squamous Non-small Cell Lung CancerPhase 2INTerpath-13NCT07221474

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

A Phase 2 study testing Intismeran Autogene, Pembrolizumab and Carboplatin in people with Squamous Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 55 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Non-small Cell Lung Cancer
What is being tested?
Intismeran Autogene, Pembrolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
55 sitesin 11 countries
Study dates
12 Dec 2025to 6 May 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

55 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

55 sites in 11 countries

United States11 sites, 11 recruiting

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

    Albany, New York, 12206

    Study Coordinator, 518-489-0044

    Recruiting

  • VA Ann Arbor Healthcare System ( Site 0019)

    Ann Arbor, Michigan, 48105

    Study Coordinator, 734-769-7100

    Recruiting

  • Texas Oncology - Central/South Texas ( Site 8002)

    Austin, Texas, 78745

    Study Coordinator, 512-427-9400

    Recruiting

  • Cleveland Clinic - Ohio ( Site 0016)

    Cleveland, Ohio, 44195

    Study Coordinator, 216-445-7855

    Recruiting

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

    Corvallis, Oregon, 97330

    Study Coordinator, 541-768-4950

    Recruiting

  • Virginia Cancer Specialists ( Site 0003)

    Fairfax, Virginia, 22031

    Study Coordinator, 730-280-5390

    Recruiting

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

    Nashville, Tennessee, 37203

    Study Coordinator, 615-961-9469

    Recruiting

  • Valley Health Systems - Ridgewood Campus ( Site 0010)

    Paramus, New Jersey, 07652

    Study Coordinator, 201-634-5578

    Recruiting

  • Swedish Medical Center-Swedish Cancer Institute ( Site 0023)

    Seattle, Washington, 98104

    Study Coordinator, 855-922-6237

    Recruiting

  • Washington University School of Medicine ( Site 0024)

    St Louis, Missouri, 63110

    Study Coordinator, 314-362-5000

    Recruiting

  • Moffitt Cancer Center ( Site 0021)

    Tampa, Florida, 33612

    Study Coordinator, 813-745-7363

    Recruiting

Other trials in United States

Argentina6 sites, 6 recruiting

  • Clinica Adventista Belgrano ( Site 0206)

    Caba., Buenos Aires F.D., C1430EGF

    Study Coordinator, +5491140141500

    Recruiting

  • Instituto Alexander Fleming ( Site 0201)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218956

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0200)

    Ciudad Autonoma de Buenos Aires., Buenos Aires, C1199ABB

    Study Coordinator, +541149590497

    Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +5492235937663

    Recruiting

  • Fundacion Estudios Clinicos ( Site 0207)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +5493413168137

    Recruiting

  • Sanatorio Parque ( Site 0203)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +543874044942

    Recruiting

Other trials in Argentina

Spain6 sites, 6 recruiting

  • Hospital Universitari Vall d''Hebron ( Site 1310)

    Barcelona, 08035

    Study Coordinator, +34 93 254 3450

    Recruiting

  • ICO L Hospitalet ( Site 1311)

    Hospitalet, Barcelona, 08907

    Study Coordinator, +34 93 260 77 44

    Recruiting

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

    Jerez de la Frontera, Cadiz, 11407

    Study Coordinator, 956 03 22 44

    Recruiting

  • Hospital Ramon y Cajal ( Site 1314)

    Madrid, 28034

    Study Coordinator, +34 91 336 82 63

    Recruiting

  • Hospital Clinico San Carlos... ( Site 1313)

    Madrid, 28040

    Study Coordinator, +34 913303000

    Recruiting

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

    Seville, 41009

    Study Coordinator, +34 671560092

    Recruiting

Other trials in Spain

Taiwan6 sites, 6 recruiting

  • China Medical University Hospital ( Site 0606)

    Taichung, 404

    Study Coordinator, +886422052121

    Recruiting

  • National Cheng Kung University Hospital ( Site 0601)

    Tainan, 70403

    Study Coordinator, +88662353535

    Recruiting

  • Mackay Memorial Hospital ( Site 0604)

    Taipei, 104

    Study Coordinator, +886225433535

    Recruiting

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

    Taipei, 106

    Study Coordinator, +886223220322

    Recruiting

  • Taipei Veterans General Hospital ( Site 0602)

    Taipei, 11217

    Study Coordinator, +88628712121

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0605)

    Taoyuan, 33305

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

South Korea5 sites, 5 recruiting

  • Chungbuk National University Hospital-Internal medicine ( Site 0501)

    Cheongju-si, North Chungcheong, 28644

    Study Coordinator, 043-269-6015

    Recruiting

  • National Cancer Center ( Site 0504)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82319200114

    Recruiting

  • Seoul National University Bundang Hospital ( Site 0500)

    Seongnam-si, Kyonggi-do, 13620

    Study Coordinator, +82317877071

    Recruiting

  • Asan Medical Center ( Site 0503)

    Seoul, 05505

    Study Coordinator, +82230103215

    Recruiting

  • Samsung Medical Center ( Site 0502)

    Seoul, 06351

    Study Coordinator, +82234101132

    Recruiting

Other trials in South Korea

Chile4 sites, 4 recruiting

  • Bradford Hill Norte ( Site 0308)

    Antofagasta, 1263521

    Study Coordinator, 56442023631

    Recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0307)

    Santiago, Region M. de Santiago, 7500653

    Study Coordinator, +56991612199

    Recruiting

  • Fundación Arturo López Pérez ( Site 0300)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Bradfordhill ( Site 0301)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56 2 29490970

    Recruiting

Other trials in Chile

Italy4 sites, 4 recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 1002)

    Milan, 20132

    Study Coordinator, +390226436633

    Recruiting

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)

    Milan, 20133

    Study Coordinator, +390223903829

    Recruiting

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

    Ravenna, Emilia-Romagna, 48121

    Study Coordinator, +390544285247

    Recruiting

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

    Roma, 00168

    Study Coordinator, 00390630154277

    Recruiting

Other trials in Italy

Turkey (Türkiye)4 sites, 4 recruiting

  • Hacettepe Universitesi Tıp Fakultesi ( Site 1400)

    Ankara, 06230

    Study Coordinator, +905436067759

    Recruiting

  • Memorial Ankara Hastanesi ( Site 1401)

    Ankara, 06520

    Study Coordinator, +9005321332009

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 1402)

    Ankara, 06800

    Study Coordinator, +905384724282

    Recruiting

  • Koç Üniversitesi Hastanesi ( Site 1403)

    Istanbul, 34010

    Study Coordinator, +905369410661

    Recruiting

Other trials in Turkey (Türkiye)

Australia3 sites, 3 recruiting

  • One Clinical Research ( Site 0402)

    Nedlands, Western Australia, 6009

    Study Coordinator, +6186279 9466

    Recruiting

  • Westmead Hospital ( Site 0400)

    Westmead, New South Wales, 2145

    Study Coordinator, +61298455555

    Recruiting

  • Princess Alexandra Hospital ( Site 0403)

    Woolloongabba, Queensland, 4102

    Study Coordinator, +61731762111

    Recruiting

Other trials in Australia

France3 sites, 3 recruiting

  • Institut de Cancérologie de l'Ouest ( Site 0801)

    Angers, Pays de la Loire Region, 49055

    Study Coordinator, +33 (0)2.44 85 35 54

    Recruiting

  • CHU GABRIEL MONTPIED ( Site 0802)

    Clermont-Ferrand, Puy-de-Dome, 63001

    Study Coordinator, +33473754440

    Recruiting

  • Centre Georges François Leclerc ( Site 0805)

    Dijon, Cote-d Or, 21000

    Study Coordinator, +33345348051

    Recruiting

Other trials in France

Poland3 sites, 3 recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)

    Poznan, Greater Poland Voivodeship, 60-569

    Study Coordinator, +48616654242

    Recruiting

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

    Przemyśl, Podkarpackie Voivodeship, 37-700

    Study Coordinator, +48166775000

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225463066

    Recruiting

Other trials in Poland

About this study

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)

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.

Being tested
Intismeran Autogene, Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intismeran AutogeneBiological

    Also called mRNA-4157, V940

    1 mg Intramuscular (IM) Injection

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    200 mg IV Infusion

  • CarboplatinDrug

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

  • PaclitaxelDrug

    200 or 175 mg/m^2 IV Infusion

  • Nab-paclitaxelDrug

    100 mg/m^2 IV Infusion

  • PlaceboOther

    Placebo matched to Intismeran Autogene IM injection

Study groups in NCT07221474
Study groupRoleWhat they receive
Intismeran Autogene + Pembrolizumab + ChemoExperimentalInduction 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.
Receives: Biological: Intismeran Autogene; Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel
Placebo + Pembrolizumab + ChemoExperimentalInduction 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.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    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.

    Measured: Up to ~32 months

  2. Overall Survival (OS)

    OS, defined as the time from randomization to death due to any cause. OS will be presented.

    Measured: Up to ~42 months

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    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.

    Measured: Up to ~26 months

  2. Duration of Response (DOR)

    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.

    Measured: Up to ~42 months

  3. Number of Participants who Experience an Adverse Event (AE)

    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.

    Measured: Up to ~42 months

  4. Number of Participants who Discontinue Study Intervention Due to an AE

    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.

    Measured: Up to ~24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2025
  2. Study start12 Dec 2025
  3. Primary completion2 Jul 2029 (estimated)
  4. Study completion6 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07221474
Sponsor's protocol ID
V940-013
Other IDs
V940-013, U1111-1318-2495, 2025-520902-37-00, 2025
Acronym
INTerpath-13
Status last verified
Sep 2026
First submitted
24 Oct 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intismeran Autogene, Pembrolizumab and Carboplatin in people with Squamous Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 55 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Argentina, Spain, Taiwan, South Korea and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to ~32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07221474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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