Comparing Intismeran autogene with Pembrolizumab for non-small cell lung cancer
Official title: A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
- Phase 3
- 2 groups
- Sites in Edmonton, Brampton and 2 more cities
- Recruiting
Interventions
- Biological therapy
Intismeran autogene
IM injection
- Biological therapy
Pembrolizumab
IV infusion
- Other intervention
Placebo
IM injection
Canadian Sites (5)
5 listed, none recruiting
- Not currently recruiting
Cross Cancer Institute ( Site 0105)
Edmonton, Alberta
- Not currently recruiting
William Osler Health System ( Site 0101)
Brampton, Ontario
- Not currently recruiting
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario
- Not currently recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0104)
Montreal, Quebec
- Not currently recruiting
McGill University Health Centre ( Site 0100)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +The main inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → include but are not limited to the following:
- +Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
- +Has no evidence of disease before randomization.
- +No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
- +Has received at least one dose of adjuvant treatment with standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → platinum doublet chemotherapy.
Exclusion
- −HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → include but are not limited to the following:
- −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.
- −Received prior neoadjuvant therapy for their current NSCLC diagnosis.
- −Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
- −Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- −Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- −Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- −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 medication.
- −Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- −Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- −History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- −Active infection requiring systemic therapy.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Intismeran autogene and Pembrolizumab.
Registry label: A: Intismeran autogene + Pembrolizumab
Group B, the comparison group, receives PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → and Pembrolizumab.
Registry label: B: Placebo + Pembrolizumab
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 868 people.
The study is currently expected to finish around December 2035.
The main measurement is taken over: Up to ~78 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Disease- Free Survival (DFS) — measured over Up to ~78 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06077760 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Intismeran autogeneBiological
IM injection
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PembrolizumabBiological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PlaceboOther
IM injection
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to ~78 months.
The study as a whole is currently expected to finish around 2035-12-21.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 868 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Edmonton, Alberta, Canada; Brampton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Grand Rapids, Michigan, United States, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
Other Sites (17)
University of Michigan Clinical Trials Office ( Site 0058)
Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan ( Site 4003)
Grand Rapids, Michigan, United States
St. Vincent Frontier Cancer Center ( Site 0043)
Billings, Montana, United States
New York Oncology Hematology, P.C. ( Site 4012)
Albany, New York, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)
Commack, New York, United States
Memorial Sloan Kettering - Westchester ( Site 4058)
Harrison, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)
Mineola, New York, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0010)
New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0034)
New York, New York, United States
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0029)
New York, New York, United States
Stony Brook University-Cancer Center ( Site 0072)
Stony Brook, New York, United States
Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)
The Bronx, New York, United States
Memorial Sloan Kettering - Nassau ( Site 4060)
Uniondale, New York, United States
Swedish Medical Center-Swedish Cancer Institute ( Site 0088)
Seattle, Washington, United States
Fred Hutchinson Cancer Center ( Site 0002)
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.