Tests intismeran autogene with pembrolizumab after surgery for lung cancer
Tests whether adding intismeran autogene to pembrolizumab helps prevent lung cancer from returning in adults.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Halifax, Hamilton, Kingston, Montreal, Oshawa, Québec, and Toronto, CanadaSee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT06623422, who can take part
Where in Canada
- Queen Elizabeth II Health Sciences Centre (Site 1101)Halifax, CanadaTaking people
- Hamilton Health Sciences - Juravinski Site (Site 1104)Hamilton, CanadaTaking people
- Kingston Health Sciences Centre-Kingston General Hospital Site (Site 1105)Kingston, CanadaTaking people
- McGill University Health Centre (Site 1103)Montreal, CanadaTaking people
- Lakeridge Health (Site 1107)Oshawa, CanadaTaking people
- IUCPQ (Site 1112)Québec, CanadaTaking people
- Sunnybrook Research Institute (Site 1106)Toronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06623422EU 2023-506327-29-00
- Record updated
- 9 November 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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.
Exclusion: Received prior neoadjuvant therapy for their current NSCLC diagnosis; 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; 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; 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); The main exclusion criteria include but are not limited to the following:; Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements.