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
- Aurora, Bethlehem, Boston, Buffalo, Charlotte, Chattanooga, Chicago, Cincinnati, Colorado Springs, Columbia, Corvallis, Dallas, East Syracuse, Fairfax, Fort Lauderdale, Fullerton, Gilbert, Greeley, Houston, Indianapolis, Knoxville, Long Beach, Los Angeles, Memphis, Miami, Nashville, New Haven, New York, Norfolk, Norwich, Osage Beach, Peoria, Post Falls, Richmond, Rockville, San Francisco, Seattle, Silverdale, Syracuse, The Bronx, Tucson, Tyler, Valhalla, Westminster, and Winston-Salem, United StatesSee the 54 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 United States
- University of Colorado Anschutz Medical Campus (Site 0151)Aurora, United StatesTaking people
- St. Lukes Hospital and Health Network (Site 0186)Bethlehem, United StatesTaking people
- Dana Farber Cancer Hospital (Site 0155)Boston, United StatesTaking people
- Massachusetts General Hospital (Site 0136)Boston, United StatesTaking people
- Roswell Park Cancer Institute (Site 0184)Buffalo, United StatesTaking people
- Novant Health Weisiger Cancer Insititute (Site 0266)Charlotte, United StatesTaking people
- Tennessee Oncology, PLLC - Chattanooga Downtown (Site 0315)Chattanooga, United StatesTaking people
- The University of Chicago Medical Center (Site 0118)Chicago, United StatesTaking people
- University of Cincinnati Medical Center (Site 0119)Cincinnati, United StatesTaking people
- UCHealth Memorial Hospital Central (Site 0125)Colorado Springs, United StatesTaking people
- Ellis Fischel Cancer Center (Site 0133)Columbia, United StatesNo longer taking part
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center (Site 0217)Corvallis, United StatesTaking people
- Texas Oncology - DFW (Site 8103)Dallas, United StatesTaking people
- UT Southwestern Medical Center (Site 0190)Dallas, United StatesTaking people
- Hematology-Oncology Associates of CNY (Site 0164)East Syracuse, United StatesTaking people
- Virginia Cancer Specialists (Site 0167)Fairfax, United StatesTaking people
- The Oncology Institute of Hope and Innovation - Fort Lauderdale (Site 0156)Fort Lauderdale, United StatesTaking people
- Providence St. Jude Medical Center (Site 0106)Fullerton, United StatesTaking people
- Banner MD Anderson Cancer Center (Site 0181)Gilbert, United StatesTaking people
- Banner MD Anderson Cancer Center at North Colorado Medical Center (Site 0207)Greeley, United StatesTaking people
- Houston Methodist Cancer Center (Site 0191)Houston, United StatesTaking people
- MD Anderson Cancer Center (Site 0150)Houston, United StatesTaking people
- Memorial Hermann Cancer Center (Site 0172)Houston, United StatesTaking people
- Michael E. DeBakey VA Medical Center (Site 0197)Houston, United StatesTaking people
- O'Quinn Medical Tower at McNair Campus (Site 0131)Houston, United StatesTaking people
- Franciscan Health (Site 0219)Indianapolis, United StatesTaking people
- Thompson Cancer Survival Center (Site 0168)Knoxville, United StatesTaking people
- VA Long Beach Healthcare System (Site 0199)Long Beach, United StatesTaking people
- UCLA Jonsson Comprehensive Cancer Center (Site 0135)Los Angeles, United StatesTaking people
- USC Norris Comprehensive Cancer Center (Site 0205)Los Angeles, United StatesTaking people
- Baptist Clinical Research Institute, Inc. (Site 9501)Memphis, United StatesTaking people
- Miami Cancer Institute at Baptist Health, Inc. (Site 0214)Miami, United StatesTaking people
- Elliston Place Medical Oncology & Hematology (Site 0215)Nashville, United StatesTaking people
- Yale University School of Medicine (Site 0201)New Haven, United StatesTaking people
- Icahn School of Medicine at Mount Sinai (Site 0116)New York, United StatesTaking people
- Memorial Sloan Kettering Cancer Center (Site 0137)New York, United StatesTaking people
- The Blavatnik Family- Chelsea Medical Center at Mount Sinai (Site 0216)New York, United StatesTaking people
- Virginia Oncology Associates (VOA) (Site 8101)Norfolk, United StatesTaking people
- Eastern CT Hematology & Oncology Associates (Site 0202)Norwich, United StatesTaking people
- Lake Regional Hospital-Cancer Center (Site 0123)Osage Beach, United StatesNo longer taking part
- Illinois Cancer Care (Site 8107)Peoria, United StatesTaking people
- Beacon Cancer Care (Site 0127)Post Falls, United StatesTaking people
- VCU Health Adult Outpatient Pavillion (Site 0193)Richmond, United StatesTaking people
- Maryland Oncology Hematology (MOH) (Site 8102)Rockville, United StatesTaking people
- UCSF Medical Center at Mission Bay (Site 0178)San Francisco, United StatesTaking people
- Swedish Cancer Institute (Site 0143)Seattle, United StatesTaking people
- St. Joseph Medical Center Hematology and Oncology - Silverdale (Site 0192)Silverdale, United StatesTaking people
- SUNY Upstate Cancer Center (Site 0140)Syracuse, United StatesTaking people
- Montefiore Medical Center (Site 0160)The Bronx, United StatesTaking people
- The University of Arizona Cancer Center - North Campus (Site 0163)Tucson, United StatesTaking people
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (Site 0148)Tyler, United StatesTaking people
- Westchester Medical Center (Site 0196)Valhalla, United StatesTaking people
- Centura Health - St. Anthony North Health Campus (Site 0189)Westminster, United StatesTaking people
- Novant Health Forsyth Medical Center (Site 0166)Winston-Salem, United StatesTaking 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.