A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Sponsored by Merck Sharp & Dohme LLC
About this study
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).
Where this study is enrolling (50)
- Call 520-694-2873
The University of Arizona Cancer Center - North Campus ( Site 0163)
Tucson, Arizona
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- Call 480-256-6444
Banner MD Anderson Cancer Center ( Site 0181)
Gilbert, Arizona
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- Call 323-865-3000
USC Norris Comprehensive Cancer Center ( Site 0205)
Los Angeles, California
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- Call 714-446-5900
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California
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- Call 562-826-8000
VA Long Beach Healthcare System ( Site 0199)
Long Beach, California
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Show all 50 locations
- Call 877-827-3222
UCSF Medical Center at Mission Bay ( Site 0178)
San Francisco, California
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- Call 310-825-5268
UCLA Jonsson Comprehensive Cancer Center ( Site 0135)
Los Angeles, California
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- Call 303-724-9690
University of Colorado Anschutz Medical Campus ( Site 0151)
Aurora, Colorado
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- Call 970-810-3894
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
Greeley, Colorado
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- Call 719-365-5000
UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs, Colorado
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- Call 720-627-4840
Centura Health - St. Anthony North Health Campus ( Site 0189)
Westminster, Colorado
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- Call 203-785-7564
Yale University School of Medicine ( Site 0201)
New Haven, Connecticut
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- Call 860-886-8362
Eastern CT Hematology & Oncology Associates ( Site 0202)
Norwich, Connecticut
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- Call 954-771-0692
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
Fort Lauderdale, Florida
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- Call 786-596-2000
Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)
Miami, Florida
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- Call 208-755-2804
Beacon Cancer Care ( Site 0127)
Post Falls, Idaho
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- I'm interested
The University of Chicago Medical Center ( Site 0118)
Chicago, Illinois
- Call 317-528-7060
Franciscan Health ( Site 0219)
Indianapolis, Indiana
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- Call 570-808-4772
Maryland Oncology Hematology (MOH) ( Site 8102)
Rockville, Maryland
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- Call 617-724-4000
Massachusetts General Hospital ( Site 0136)
Boston, Massachusetts
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- Call 617-632-3000
Dana Farber Cancer Hospital ( Site 0155)
Boston, Massachusetts
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- Call 212-639-2000
Memorial Sloan Kettering Cancer Center ( Site 0137)
New York, New York
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- Call 212-523-5559
Icahn School of Medicine at Mount Sinai ( Site 0116)
New York, New York
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- Call 914-493-7000
Westchester Medical Center ( Site 0196)
Valhalla, New York
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- Call 315-464-8237
SUNY Upstate Cancer Center ( Site 0140)
Syracuse, New York
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- Call 315-472-7504
Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse, New York
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- Call 202-207-2510
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
New York, New York
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- Call 718-405-8404
Montefiore Medical Center ( Site 0160)
The Bronx, New York
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- Call 716-845-3167
Roswell Park Cancer Institute ( Site 0184)
Buffalo, New York
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- Call 336-718-5000
Novant Health Forsyth Medical Center ( Site 0166)
Winston-Salem, North Carolina
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- Call 980-302-6000
Novant Health Weisiger Cancer Insititute ( Site 0266)
Charlotte, North Carolina
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- Call 513-558-2119
University of Cincinnati Medical Center ( Site 0119)
Cincinnati, Ohio
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- Call 541-768-4950
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)
Corvallis, Oregon
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- Call 484-526-7952
St. Lukes Hospital and Health Network ( Site 0186)
Bethlehem, Pennsylvania
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- Call 615-961-9469
Elliston Place Medical Oncology & Hematology ( Site 0215)
Nashville, Tennessee
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- Call 615-961-9469
Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)
Chattanooga, Tennessee
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- Call 865-331-1720
Thompson Cancer Survival Center ( Site 0168)
Knoxville, Tennessee
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- I'm interested
Memorial Hermann Cancer Center ( Site 0172)
Houston, Texas
- Call 877-632-6789
MD Anderson Cancer Center ( Site 0150)
Houston, Texas
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- Call 903-592-6152
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
Tyler, Texas
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- Call 713-873-200
Michael E. DeBakey VA Medical Center ( Site 0197)
Houston, Texas
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- I'm interested
Houston Methodist Cancer Center ( Site 0191)
Houston, Texas
- Call 214-370-1987
Texas Oncology - DFW ( Site 8103)
Dallas, Texas
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- Call 214-648-3111
UT Southwestern Medical Center ( Site 0190)
Dallas, Texas
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- I'm interested
O'Quinn Medical Tower at McNair Campus ( Site 0131)
Houston, Texas
- Call 804-828-7999
VCU Health Adult Outpatient Pavillion ( Site 0193)
Richmond, Virginia
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- Call 571-350-8400
Virginia Cancer Specialists ( Site 0167)
Fairfax, Virginia
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- Call 757-466-8683
Virginia Oncology Associates (VOA) ( Site 8101)
Norfolk, Virginia
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- Call 564-240-3100
St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)
Silverdale, Washington
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- Call 855-922-6237
Swedish Cancer Institute ( Site 0143)
Seattle, Washington
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Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.