A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

Study summary

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPembrolizumab and Cisplatin

Plus 6 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?244 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Interventions being studied: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Paclitaxel; Biological: Intismeran autogene; Other: Placebo

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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)→

Treatment approach

Immunotherapy→Chemotherapy→Surgery→

Study topics

Before surgery (neoadjuvant)→After surgery (adjuvant)→

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

The main inclusion criteria include but are not limited to the following:
Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) positive 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 at screening

Reasons someone may not be able to joinExclusion criteria

The main

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

Study sites

U.S. locations

Banner MD Anderson Cancer Center ( Site 0181)Gilbert, Arizona
The University of Arizona Cancer Center - North Campus ( Site 0163)Tucson, Arizona
Providence St. Jude Medical Center ( Site 0106)Fullerton, California
VA Long Beach Healthcare System ( Site 0199)Long Beach, California
USC Norris Comprehensive Cancer Center ( Site 0205)Los Angeles, California
UCLA Jonsson Comprehensive Cancer Center ( Site 0135)Los Angeles, California
UCSF Medical Center at Mission Bay ( Site 0178)San Francisco, California
University of Colorado Anschutz Medical Campus ( Site 0151)Aurora, Colorado
UCHealth Memorial Hospital Central ( Site 0125)Colorado Springs, Colorado
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)Greeley, Colorado
Centura Health - St. Anthony North Health Campus ( Site 0189)Westminster, Colorado
Yale University School of Medicine ( Site 0201)New Haven, Connecticut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2026. Always confirm current availability with the study team.

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