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A Study of Intismeran Autogene for Squamous Non-Small Cell Lung Cancer

This study is looking into whether a treatment called intismeran autogene, when given with pembrolizumab and chemotherapy (carboplatin, paclitaxel, or nab-paclitaxel), can help people with metastatic squamous non-small cell lung cancer (NSCLC) that hasn't been treated before. Intismeran autogene is designed to help your body's immune system fight your specific cancer. Researchers want to see if people who receive intismeran autogene live longer overall and without their cancer growing or spreading, compared to those who receive a placebo (an inactive substance that looks like the study treatment) along with pembrolizumab and chemotherapy. The study plans to enroll about 180 participants who are 18 years or older and have a confirmed diagnosis of squamous NSCLC. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 180 participants. It compares intismeran autogene plus pembrolizumab and chemotherapy to a placebo plus pembrolizumab and chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression Free Survival (PFS) for up to about 32 months and Overall Survival (OS) for up to about 42 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221474

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~180 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Intismeran AutogenePembrolizumabCarboplatinPaclitaxelNab-paclitaxelPlacebo

At a glance

Recruiting sites
55 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Up to ~32 months
+1 more outcome measured

Conditions

Squamous Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

55 sites across 35 states
Taiwan6
Spain4
Turkey (Türkiye)4
Buenos Aires3
Region M. de Santiago3
Italy3
Santa Fe Province2
Kyonggi-do2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression Free Survival (PFS)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.

  • Overall Survival (OS)Up to ~42 months

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