Comparing Intismeran autogene with Pembrolizumab for non-small-cell lung carcinoma
Official title: A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
- Phase 3
- 2 groups
- Sites in Halifax, Hamilton and 5 more cities
- Recruiting
Interventions (8)
- Biological therapy
Pembrolizumab
IV Infusion
- Medication
Cisplatin
IV infusion
- Medication
Carboplatin
IV infusion
- Medication
Pemetrexed
IV infusion
- Medication
Gemcitabine
IV infusion
- Medication
Paclitaxel
IV infusion
- Biological therapy
Intismeran autogene
IM injection
- Other intervention
Placebo
IM injection
Canadian Sites (7)
7 of 7 recruiting
- Recruiting
Queen Elizabeth II Health Sciences Centre ( Site 1101)
Halifax, Nova Scotia
- Recruiting
Hamilton Health Sciences - Juravinski Site ( Site 1104)
Hamilton, Ontario
- Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1105)
Kingston, Ontario
- Recruiting
Lakeridge Health ( Site 1107)
Oshawa, Ontario
- Recruiting
Sunnybrook Research Institute ( Site 1106)
Toronto, Ontario
- Recruiting
McGill University Health Centre ( Site 1103)
Montreal, Quebec
- Recruiting
IUCPQ ( Site 1112)
Québec, Quebec
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 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 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
Exclusion
- −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, 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 protocolProtocolThe detailed plan a study must follow.Read more →
- −Received prior treatment with a cancer vaccine
- −Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- −Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
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 Pembrolizumab and Intismeran autogene, together with one or more of: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine and Paclitaxel.
Registry label: A: Pembrolizumab + Intismeran autogene
Group B, the comparison group, receives Pembrolizumab and PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →, together with one or more of: Cisplatin, Carboplatin, Pemetrexed, Gemcitabine and Paclitaxel.
Registry label: B: Pembrolizumab + Placebo
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 680 people.
The study is currently expected to finish around January 2038.
The main measurement is taken over: Up to ~97 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 ~97 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06623422 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 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 CisplatinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarboplatinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PemetrexedDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GemcitabineDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
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 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 ~97 months.
The study as a whole is currently expected to finish around 2038-01-26.
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 680 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Oshawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 9 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 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).
Other Sites (10)
Roswell Park Cancer Institute ( Site 0184)
Buffalo, New York, United States
Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse, New York, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0116)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0137)
New York, New York, United States
SUNY Upstate Cancer Center ( Site 0140)
Syracuse, New York, United States
Montefiore Medical Center ( Site 0160)
The Bronx, New York, United States
Westchester Medical Center ( Site 0196)
Valhalla, New York, United States
Swedish Cancer Institute ( Site 0143)
Seattle, Washington, United States
St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)
Silverdale, 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.