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)
- Carcinoma, Non-Small-Cell Lung
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 680
- Started
- 21 October 2024
- Main results due
- 16 May 2033
- Study sites
- 242
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 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 Criteria: The main exclusion criteria 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 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 study is about
In the sponsor’s own words, from the registry.
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).
Study sites(242)
Banner MD Anderson Cancer Center ( Site 0181)
Gilbert, Arizona, United States
Recruiting
The University of Arizona Cancer Center - North Campus ( Site 0163)
Tucson, Arizona, United States
Recruiting
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California, United States
Recruiting
VA Long Beach Healthcare System ( Site 0199)
Long Beach, California, United States
Recruiting
USC Norris Comprehensive Cancer Center ( Site 0205)
Los Angeles, California, United States
Recruiting
UCLA Jonsson Comprehensive Cancer Center ( Site 0135)
Los Angeles, California, United States
Recruiting
UCSF Medical Center at Mission Bay ( Site 0178)
San Francisco, California, United States
Recruiting
University of Colorado Anschutz Medical Campus ( Site 0151)
Aurora, Colorado, United States
Recruiting
UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs, Colorado, United States
Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
Greeley, Colorado, United States
Recruiting
Centura Health - St. Anthony North Health Campus ( Site 0189)
Westminster, Colorado, United States
Recruiting
Yale University School of Medicine ( Site 0201)
New Haven, Connecticut, United States
Recruiting
Eastern CT Hematology & Oncology Associates ( Site 0202)
Norwich, Connecticut, United States
Recruiting
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
Fort Lauderdale, Florida, United States
Recruiting
Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)
Miami, Florida, United States
Recruiting
Beacon Cancer Care ( Site 0127)
Post Falls, Idaho, United States
Recruiting
The University of Chicago Medical Center ( Site 0118)
Chicago, Illinois, United States
Recruiting
Franciscan Health ( Site 0219)
Indianapolis, Indiana, United States
Recruiting
Maryland Oncology Hematology (MOH) ( Site 8102)
Rockville, Maryland, United States
Recruiting
Massachusetts General Hospital ( Site 0136)
Boston, Massachusetts, United States
Recruiting
Dana Farber Cancer Hospital ( Site 0155)
Boston, Massachusetts, United States
Recruiting
Ellis Fischel Cancer Center ( Site 0133)
Columbia, Missouri, United States
Completed
Lake Regional Hospital-Cancer Center ( Site 0123)
Osage Beach, Missouri, United States
Completed
Roswell Park Cancer Institute ( Site 0184)
Buffalo, New York, United States
Recruiting
Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse, New York, United States
Recruiting
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
New York, New York, United States
Recruiting
Icahn School of Medicine at Mount Sinai ( Site 0116)
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0137)
New York, New York, United States
Recruiting
SUNY Upstate Cancer Center ( Site 0140)
Syracuse, New York, United States
Recruiting
Montefiore Medical Center ( Site 0160)
The Bronx, New York, United States
Recruiting
Westchester Medical Center ( Site 0196)
Valhalla, New York, United States
Recruiting
Novant Health Weisiger Cancer Insititute ( Site 0266)
Charlotte, North Carolina, United States
Recruiting
Novant Health Forsyth Medical Center ( Site 0166)
Winston-Salem, North Carolina, United States
Recruiting
University of Cincinnati Medical Center ( Site 0119)
Cincinnati, Ohio, United States
Recruiting
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)
Corvallis, Oregon, United States
Recruiting
St. Lukes Hospital and Health Network ( Site 0186)
Bethlehem, Pennsylvania, United States
Recruiting
Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)
Chattanooga, Tennessee, United States
Recruiting
Thompson Cancer Survival Center ( Site 0168)
Knoxville, Tennessee, United States
Recruiting
Elliston Place Medical Oncology & Hematology ( Site 0215)
Nashville, Tennessee, United States
Recruiting
Texas Oncology - DFW ( Site 8103)
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center ( Site 0190)
Dallas, Texas, United States
Recruiting
Houston Methodist Cancer Center ( Site 0191)
Houston, Texas, United States
Recruiting
MD Anderson Cancer Center ( Site 0150)
Houston, Texas, United States
Recruiting
Memorial Hermann Cancer Center ( Site 0172)
Houston, Texas, United States
Recruiting
Michael E. DeBakey VA Medical Center ( Site 0197)
Houston, Texas, United States
Recruiting
O'Quinn Medical Tower at McNair Campus ( Site 0131)
Houston, Texas, United States
Recruiting
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
Tyler, Texas, United States
Recruiting
Virginia Cancer Specialists ( Site 0167)
Fairfax, Virginia, United States
Recruiting
Virginia Oncology Associates (VOA) ( Site 8101)
Norfolk, Virginia, United States
Recruiting
VCU Health Adult Outpatient Pavillion ( Site 0193)
Richmond, Virginia, United States
Recruiting
Swedish Cancer Institute ( Site 0143)
Seattle, Washington, United States
Recruiting
St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)
Silverdale, Washington, United States
Recruiting
CEMIC ( Site 2454)
Caba., Buenos Aires, Argentina
Recruiting
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)
Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Recruiting
Fundacion Intecnus ( Site 2456)
Bariloche, Río Negro Province, Argentina
Recruiting
Centro Médico IPAM ( Site 2452)
Rosario, Santa Fe Province, Argentina
Recruiting
Instituto Medico Especializado Alexander Fleming ( Site 2457)
Buenos Aires, Argentina
Recruiting
Instituto Oncologico de Cordoba -IONC ( Site 2455)
Córdoba, Argentina
Recruiting
Calvary Mater Newcastle ( Site 2106)
Waratah, New South Wales, Australia
Recruiting
Tasman Oncology Research ( Site 2104)
Southport, Queensland, Australia
Completed
Showing 60 of 242 sites — filter to narrow it down. 234 of the 242 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06623422. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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