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Pembrolizumab with or without Intismeran Autogene for Non-Small Cell Lung Cancer

This study is looking into whether adding intismeran autogene to pembrolizumab (a type of immunotherapy) after surgery can help prevent non-small cell lung cancer (NSCLC) from returning. You might be able to join if you have NSCLC that is resectable (can be removed with surgery) and your cancer didn't completely respond to treatment before surgery. Researchers want to see if this combination keeps people cancer-free for a longer time compared to receiving pembrolizumab with a placebo (an inactive substance). The study aims to enroll 680 participants and will measure how long people remain free of disease for up to about 97 months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 680 participants. It compares two treatment groups: pembrolizumab with intismeran autogene versus pembrolizumab with a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure how long they remain disease-free for up to approximately 97 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.

NCT06623422

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~680 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:PembrolizumabCisplatinCarboplatinPemetrexedGemcitabinePaclitaxel

At a glance

Recruiting sites
233 of 241 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Survival (DFS)
Measured over Up to ~97 months

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

241 sites across 134 states
Taiwan9
New York8
Texas8
Japan7
California5
Rio Grande do Sul5
Israel5
Italy5

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 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

Exclusion

Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
Received prior neoadjuvant therapy for their current NSCLC diagnosis
Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
Received prior treatment with a cancer vaccine
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

What this trial measures

  • Disease-Free Survival (DFS)Up to ~97 months

    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.