A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Recruiting · NCT06623422 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 20 US states.
- Banner MD Anderson Cancer Center ( Site 0181) - Gilbert, Arizona, United States
- The University of Arizona Cancer Center - North Campus ( Site 0163) - Tucson, Arizona, United States
- Providence St. Jude Medical Center ( Site 0106) - Fullerton, California, United States
- VA Long Beach Healthcare System ( Site 0199) - Long Beach, California, United States
- USC Norris Comprehensive Cancer Center ( Site 0205) - Los Angeles, California, United States
- UCLA Jonsson Comprehensive Cancer Center ( Site 0135) - Los Angeles, California, United States
- UCSF Medical Center at Mission Bay ( Site 0178) - San Francisco, California, United States
- University of Colorado Anschutz Medical Campus ( Site 0151) - Aurora, Colorado, United States
- UCHealth Memorial Hospital Central ( Site 0125) - Colorado Springs, Colorado, United States
- Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207) - Greeley, Colorado, United States
- Centura Health - St. Anthony North Health Campus ( Site 0189) - Westminster, Colorado, United States
- Yale University School of Medicine ( Site 0201) - New Haven, Connecticut, United States
- Eastern CT Hematology & Oncology Associates ( Site 0202) - Norwich, Connecticut, United States
- The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156) - Fort Lauderdale, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc. ( Site 0214) - Miami, Florida, United States
- Beacon Cancer Care ( Site 0127) - Post Falls, Idaho, United States
- The University of Chicago Medical Center ( Site 0118) - Chicago, Illinois, United States
- Franciscan Health ( Site 0219) - Indianapolis, Indiana, United States
- Maryland Oncology Hematology (MOH) ( Site 8102) - Rockville, Maryland, United States
- Massachusetts General Hospital ( Site 0136) - Boston, Massachusetts, United States
- Dana Farber Cancer Hospital ( Site 0155) - Boston, Massachusetts, United States
- Ellis Fischel Cancer Center ( Site 0133) - Columbia, Missouri, United States
- Lake Regional Hospital-Cancer Center ( Site 0123) - Osage Beach, Missouri, United States
- Roswell Park Cancer Institute ( Site 0184) - Buffalo, New York, United States
- Hematology-Oncology Associates of CNY ( Site 0164) - East Syracuse, New York, United States
- The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216) - New York, New York, United States
- Icahn School of Medicine at Mount Sinai ( Site 0116) - New York, New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 0137) - New York, New York, United States
- SUNY Upstate Cancer Center ( Site 0140) - Syracuse, New York, United States
- Montefiore Medical Center ( Site 0160) - The Bronx, New York, United States
- Westchester Medical Center ( Site 0196) - Valhalla, New York, United States
- Novant Health Weisiger Cancer Insititute ( Site 0266) - Charlotte, North Carolina, United States
- Novant Health Forsyth Medical Center ( Site 0166) - Winston-Salem, North Carolina, United States
- University of Cincinnati Medical Center ( Site 0119) - Cincinnati, Ohio, United States
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217) - Corvallis, Oregon, United States
- St. Lukes Hospital and Health Network ( Site 0186) - Bethlehem, Pennsylvania, United States
- Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315) - Chattanooga, Tennessee, United States
- Thompson Cancer Survival Center ( Site 0168) - Knoxville, Tennessee, United States
- Elliston Place Medical Oncology & Hematology ( Site 0215) - Nashville, Tennessee, United States
- Texas Oncology - DFW ( Site 8103) - Dallas, Texas, United States
- UT Southwestern Medical Center ( Site 0190) - Dallas, Texas, United States
- Houston Methodist Cancer Center ( Site 0191) - Houston, Texas, United States
- MD Anderson Cancer Center ( Site 0150) - Houston, Texas, United States
- Memorial Hermann Cancer Center ( Site 0172) - Houston, Texas, United States
- Michael E. DeBakey VA Medical Center ( Site 0197) - Houston, Texas, United States
- O'Quinn Medical Tower at McNair Campus ( Site 0131) - Houston, Texas, United States
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148) - Tyler, Texas, United States
- Virginia Cancer Specialists ( Site 0167) - Fairfax, Virginia, United States
- Virginia Oncology Associates (VOA) ( Site 8101) - Norfolk, Virginia, United States
- VCU Health Adult Outpatient Pavillion ( Site 0193) - Richmond, Virginia, United States
- Swedish Cancer Institute ( Site 0143) - Seattle, Washington, United States
- St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192) - Silverdale, Washington, United States
- Adana Medical Park Seyhan Hastanesi ( Site 2010) - Adana, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi ( Site 2002) - Ankara, Turkey (Türkiye)
- Bradford Hill Norte ( Site 2563) - Antofagasta, Chile
- Hospital Universitari Vall D Hebron ( Site 1910) - Barcelona, Spain
- Hospital Clinic de Barcelona ( Site 1919) - Barcelona, Spain
- S.C. ONCO CARD S.R.L ( Site 1805) - Brasov, Romania
- Orszagos Koranyi Pulmonologiai Intezet ( Site 1501) - Budapest, Hungary
- Instituto Medico Especializado Alexander Fleming ( Site 2457) - Buenos Aires, Argentina
Showing 60 of 241 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →