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RecruitingPhase 2NCT07221474
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIntismeran Autogene and Pembrolizumab

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?55 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Biological: Intismeran Autogene; Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Other: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Moffitt Cancer Center ( Site 0021)Tampa, Florida
  • VA Ann Arbor Healthcare System ( Site 0019)Ann Arbor, Michigan
  • Washington University School of Medicine ( Site 0024)St Louis, Missouri
  • Valley Health Systems - Ridgewood Campus ( Site 0010)Paramus, New Jersey
  • New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)Albany, New York
  • Cleveland Clinic - Ohio ( Site 0016)Cleveland, Ohio
  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)Corvallis, Oregon
  • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)Nashville, Tennessee
  • Texas Oncology - Central/South Texas ( Site 8002)Austin, Texas
  • Virginia Cancer Specialists ( Site 0003)Fairfax, Virginia
  • Swedish Medical Center-Swedish Cancer Institute ( Site 0023)Seattle, Washington
  • Hospital Italiano de Buenos Aires ( Site 0200)Ciudad Autonoma de Buenos Aires., Buenos Aires

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 1, 2026. Always confirm current availability with the study team.

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