A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Recruiting · NCT06077760 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
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 undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
- Has no evidence of disease before randomization.
- Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
- No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
- 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.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
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.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Received prior neoadjuvant therapy for their current NSCLC diagnosis.
- Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
- Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
- Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Active infection requiring systemic therapy.
Where it is running
60 locations listed across 29 US states.
- Alaska Oncology and Hematology ( Site 0039) - Anchorage, Alaska, United States
- The University of Arizona Cancer Center - North Campus ( Site 0071) - Tucson, Arizona, United States
- YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020) - Yuma, Arizona, United States
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0059) - Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian ( Site 4042) - Newport Beach, California, United States
- Hoag Memorial Hospital Presbyterian ( Site 4048) - Newport Beach, California, United States
- St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074) - Orange, California, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030) - Orange, California, United States
- UCHealth Memorial Hospital-Heme Onc ( Site 0052) - Colorado Springs, Colorado, United States
- George Washington University Medical Faculty Associates ( Site 4064) - Washington D.C., District of Columbia, United States
- Mayo Clinic Florida ( Site 4043) - Jacksonville, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc. ( Site 4047) - Miami, Florida, United States
- Mid Florida Hematology and Oncology Center ( Site 0014) - Orange City, Florida, United States
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013) - Orlando, Florida, United States
- Moffitt Cancer Center ( Site 0078) - Tampa, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012) - Marietta, Georgia, United States
- Southeastern Regional Medical Center ( Site 0098) - Newnan, Georgia, United States
- Beacon Cancer Care ( Site 0044) - Post Falls, Idaho, United States
- Illinois Cancer Care ( Site 7003) - Peoria, Illinois, United States
- University of Iowa-Holden Comprehensive Cancer Center ( Site 0062) - Iowa City, Iowa, United States
- Saint Elizabeth Healthcare ( Site 0092) - Edgewood, Kentucky, United States
- The University of Louisville, James Graham Brown Cancer Center ( Site 0037) - Louisville, Kentucky, United States
- LSU Health Baton Rouge North Clinic ( Site 4040) - Baton Rouge, Louisiana, United States
- Our Lady of the Lake RMC-Clinical Research ( Site 4050) - Baton Rouge, Louisiana, United States
- University of Michigan Clinical Trials Office ( Site 0058) - Ann Arbor, Michigan, United States
- Cancer and Hematology Centers of Western Michigan ( Site 4003) - Grand Rapids, Michigan, United States
- St. Vincent Frontier Cancer Center ( Site 0043) - Billings, Montana, United States
- NHO Revive Research Institute, LLC ( Site 4009) - Lincoln, Nebraska, United States
- Memorial Sloan Kettering - Basking Ridge ( Site 4056) - Basking Ridge, New Jersey, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036) - Hackensack, New Jersey, United States
- Memorial Sloan Kettering - Monmouth ( Site 4057) - Middletown, New Jersey, United States
- Memorial Sloan Kettering - Bergen ( Site 4059) - Montvale, New Jersey, United States
- Atlantic Health Morristown Medical Center ( Site 4018) - Morristown, New Jersey, United States
- New York Oncology Hematology, P.C. ( Site 4012) - Albany, New York, United States
- Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055) - Commack, New York, United States
- Memorial Sloan Kettering - Westchester ( Site 4058) - Harrison, New York, United States
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095) - Mineola, New York, United States
- The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053) - New York, New York, United States
- Laura and Isaac Perlmutter Cancer Center ( Site 0010) - New York, New York, United States
- Icahn School of Medicine at Mount Sinai ( Site 0034) - New York, New York, United States
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054) - New York, New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 0029) - New York, New York, United States
- Stony Brook University-Cancer Center ( Site 0072) - Stony Brook, New York, United States
- Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080) - The Bronx, New York, United States
- Memorial Sloan Kettering - Nassau ( Site 4060) - Uniondale, New York, United States
- Novant Health Weisiger Cancer Insititute ( Site 4052) - Charlotte, North Carolina, United States
- Novant Health Oncology Specialists ( Site 4045) - Winston-Salem, North Carolina, United States
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063) - Fargo, North Dakota, United States
- Altru Health System ( Site 0040) - Grand Forks, North Dakota, United States
- Summa Health ( Site 4011) - Akron, Ohio, United States
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028) - Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center ( Site 0023) - Cleveland, Ohio, United States
- OSU Brain and Spine Hospital ( Site 0016) - Columbus, Ohio, United States
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082) - Corvallis, Oregon, United States
- Thomas Jefferson University - Clinical Research Institute ( Site 0006) - Philadelphia, Pennsylvania, United States
- Medical University of South Carolina-Hollings Cancer Center ( Site 0050) - Charleston, South Carolina, United States
- Sanford Cancer Center ( Site 0075) - Sioux Falls, South Dakota, United States
- Greco-Hainsworth Centers for Research ( Site 4034) - Chattanooga, Tennessee, United States
- Thompson Cancer Survival Center ( Site 0097) - Knoxville, Tennessee, United States
- Baptist Cancer Center ( Site 4049) - Memphis, Tennessee, United States
Showing 60 of 229 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →