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Phase 3Recruiting

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)

  • The University of Arizona Cancer Center - North Campus ( Site 0163)

    Tucson, Arizona

    Call 520-694-2873

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  • Banner MD Anderson Cancer Center ( Site 0181)

    Gilbert, Arizona

    Call 480-256-6444

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  • USC Norris Comprehensive Cancer Center ( Site 0205)

    Los Angeles, California

    Call 323-865-3000

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  • Providence St. Jude Medical Center ( Site 0106)

    Fullerton, California

    Call 714-446-5900

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  • VA Long Beach Healthcare System ( Site 0199)

    Long Beach, California

    Call 562-826-8000

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Show all 50 locations
  • UCSF Medical Center at Mission Bay ( Site 0178)

    San Francisco, California

    Call 877-827-3222

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  • UCLA Jonsson Comprehensive Cancer Center ( Site 0135)

    Los Angeles, California

    Call 310-825-5268

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  • University of Colorado Anschutz Medical Campus ( Site 0151)

    Aurora, Colorado

    Call 303-724-9690

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  • Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)

    Greeley, Colorado

    Call 970-810-3894

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  • UCHealth Memorial Hospital Central ( Site 0125)

    Colorado Springs, Colorado

    Call 719-365-5000

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  • Centura Health - St. Anthony North Health Campus ( Site 0189)

    Westminster, Colorado

    Call 720-627-4840

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  • Yale University School of Medicine ( Site 0201)

    New Haven, Connecticut

    Call 203-785-7564

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  • Eastern CT Hematology & Oncology Associates ( Site 0202)

    Norwich, Connecticut

    Call 860-886-8362

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  • The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)

    Fort Lauderdale, Florida

    Call 954-771-0692

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  • Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)

    Miami, Florida

    Call 786-596-2000

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  • Beacon Cancer Care ( Site 0127)

    Post Falls, Idaho

    Call 208-755-2804

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  • The University of Chicago Medical Center ( Site 0118)

    Chicago, Illinois

    I'm interested
  • Franciscan Health ( Site 0219)

    Indianapolis, Indiana

    Call 317-528-7060

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  • Maryland Oncology Hematology (MOH) ( Site 8102)

    Rockville, Maryland

    Call 570-808-4772

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  • Massachusetts General Hospital ( Site 0136)

    Boston, Massachusetts

    Call 617-724-4000

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  • Dana Farber Cancer Hospital ( Site 0155)

    Boston, Massachusetts

    Call 617-632-3000

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  • Memorial Sloan Kettering Cancer Center ( Site 0137)

    New York, New York

    Call 212-639-2000

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  • Icahn School of Medicine at Mount Sinai ( Site 0116)

    New York, New York

    Call 212-523-5559

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  • Westchester Medical Center ( Site 0196)

    Valhalla, New York

    Call 914-493-7000

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  • SUNY Upstate Cancer Center ( Site 0140)

    Syracuse, New York

    Call 315-464-8237

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  • Hematology-Oncology Associates of CNY ( Site 0164)

    East Syracuse, New York

    Call 315-472-7504

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  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)

    New York, New York

    Call 202-207-2510

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  • Montefiore Medical Center ( Site 0160)

    The Bronx, New York

    Call 718-405-8404

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  • Roswell Park Cancer Institute ( Site 0184)

    Buffalo, New York

    Call 716-845-3167

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  • Novant Health Forsyth Medical Center ( Site 0166)

    Winston-Salem, North Carolina

    Call 336-718-5000

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  • Novant Health Weisiger Cancer Insititute ( Site 0266)

    Charlotte, North Carolina

    Call 980-302-6000

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  • University of Cincinnati Medical Center ( Site 0119)

    Cincinnati, Ohio

    Call 513-558-2119

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  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)

    Corvallis, Oregon

    Call 541-768-4950

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  • St. Lukes Hospital and Health Network ( Site 0186)

    Bethlehem, Pennsylvania

    Call 484-526-7952

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  • Elliston Place Medical Oncology & Hematology ( Site 0215)

    Nashville, Tennessee

    Call 615-961-9469

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  • Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)

    Chattanooga, Tennessee

    Call 615-961-9469

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  • Thompson Cancer Survival Center ( Site 0168)

    Knoxville, Tennessee

    Call 865-331-1720

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  • Memorial Hermann Cancer Center ( Site 0172)

    Houston, Texas

    I'm interested
  • MD Anderson Cancer Center ( Site 0150)

    Houston, Texas

    Call 877-632-6789

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  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)

    Tyler, Texas

    Call 903-592-6152

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  • Michael E. DeBakey VA Medical Center ( Site 0197)

    Houston, Texas

    Call 713-873-200

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  • Houston Methodist Cancer Center ( Site 0191)

    Houston, Texas

    I'm interested
  • Texas Oncology - DFW ( Site 8103)

    Dallas, Texas

    Call 214-370-1987

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  • UT Southwestern Medical Center ( Site 0190)

    Dallas, Texas

    Call 214-648-3111

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  • O'Quinn Medical Tower at McNair Campus ( Site 0131)

    Houston, Texas

    I'm interested
  • VCU Health Adult Outpatient Pavillion ( Site 0193)

    Richmond, Virginia

    Call 804-828-7999

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  • Virginia Cancer Specialists ( Site 0167)

    Fairfax, Virginia

    Call 571-350-8400

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  • Virginia Oncology Associates (VOA) ( Site 8101)

    Norfolk, Virginia

    Call 757-466-8683

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  • St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)

    Silverdale, Washington

    Call 564-240-3100

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  • Swedish Cancer Institute ( Site 0143)

    Seattle, Washington

    Call 855-922-6237

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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.