A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)
Summary
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.
Arms & interventions
- BiologicalIntismeran autogene
IM injection
- BiologicalPembrolizumab
IV infusion
- OtherPlacebo
IM injection
Outcome measures
Primary
Disease- Free Survival (DFS)
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.
Time frame: Up to ~78 months
Secondary
Overall Survival (OS)
Time frame: Up to ~12 years
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to ~12 years
Lung Cancer Specific Survival (LCSS)
Time frame: Up to ~12 years
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
Time frame: Baseline and up to ~12 years
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time frame: Baseline and up to ~12 years
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Time frame: Baseline and up to ~12 years
Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30
Time frame: Baseline and up to ~12 years
Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24
Time frame: Baseline and up to ~12 years
Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24
Time frame: Baseline and up to ~12 years
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to ~15 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to ~12 months
Eligibility criteria
Study locations (68)
Alaska Oncology and Hematology ( Site 0039)
Anchorage, Alaska, 99508
The University of Arizona Cancer Center - North Campus ( Site 0071)
Tucson, Arizona, 85719
YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)
Yuma, Arizona, 85364
UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)
Los Angeles, California, 90095
Hoag Memorial Hospital Presbyterian ( Site 4042)
Newport Beach, California, 92663
Hoag Memorial Hospital Presbyterian ( Site 4048)
Newport Beach, California, 92663
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)
Orange, California, 92868
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)
Orange, California, 92868
UCHealth Memorial Hospital-Heme Onc ( Site 0052)
Colorado Springs, Colorado, 80909
George Washington University Medical Faculty Associates ( Site 4064)
Washington D.C., District of Columbia, 20037
Mayo Clinic Florida ( Site 4043)
Jacksonville, Florida, 32224
Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)
Miami, Florida, 33176
Mid Florida Hematology and Oncology Center ( Site 0014)
Orange City, Florida, 32763
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)
Orlando, Florida, 32804
Moffitt Cancer Center ( Site 0078)
Tampa, Florida, 33612
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)
Marietta, Georgia, 30060
Southeastern Regional Medical Center ( Site 0098)
Newnan, Georgia, 30265
Beacon Cancer Care ( Site 0044)
Post Falls, Idaho, 83854
Illinois Cancer Care ( Site 7003)
Peoria, Illinois, 61615
University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)
Iowa City, Iowa, 52242
Saint Elizabeth Healthcare ( Site 0092)
Edgewood, Kentucky, 41017
The University of Louisville, James Graham Brown Cancer Center ( Site 0037)
Louisville, Kentucky, 40202
LSU Health Baton Rouge North Clinic ( Site 4040)
Baton Rouge, Louisiana, 70805
Our Lady of the Lake RMC-Clinical Research ( Site 4050)
Baton Rouge, Louisiana, 70808
University of Michigan Clinical Trials Office ( Site 0058)
Ann Arbor, Michigan, 48109
Cancer and Hematology Centers of Western Michigan ( Site 4003)
Grand Rapids, Michigan, 49503
St. Vincent Frontier Cancer Center ( Site 0043)
Billings, Montana, 59102
NHO Revive Research Institute, LLC ( Site 4009)
Lincoln, Nebraska, 68506
Memorial Sloan Kettering - Basking Ridge ( Site 4056)
Basking Ridge, New Jersey, 07920
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)
Hackensack, New Jersey, 07601
Memorial Sloan Kettering - Monmouth ( Site 4057)
Middletown, New Jersey, 07748
Memorial Sloan Kettering - Bergen ( Site 4059)
Montvale, New Jersey, 07645
Atlantic Health Morristown Medical Center ( Site 4018)
Morristown, New Jersey, 07960
New York Oncology Hematology, P.C. ( Site 4012)
Albany, New York, 12206
Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)
Commack, New York, 11725
Memorial Sloan Kettering - Westchester ( Site 4058)
Harrison, New York, 10604
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)
Mineola, New York, 11501
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)
New York, New York, 10011
Laura and Isaac Perlmutter Cancer Center ( Site 0010)
New York, New York, 10016
Icahn School of Medicine at Mount Sinai ( Site 0034)
New York, New York, 10029
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 0054)
New York, New York, 10032
Memorial Sloan Kettering Cancer Center ( Site 0029)
New York, New York, 10065
Stony Brook University-Cancer Center ( Site 0072)
Stony Brook, New York, 11794
Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)
The Bronx, New York, 10461
Memorial Sloan Kettering - Nassau ( Site 4060)
Uniondale, New York, 11553
Novant Health Weisiger Cancer Insititute ( Site 4052)
Charlotte, North Carolina, 28204
Novant Health Oncology Specialists ( Site 4045)
Winston-Salem, North Carolina, 27103
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)
Fargo, North Dakota, 58102
Altru Health System ( Site 0040)
Grand Forks, North Dakota, 58201
Summa Health ( Site 4011)
Akron, Ohio, 44304
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)
Cincinnati, Ohio, 45220
University Hospitals Cleveland Medical Center ( Site 0023)
Cleveland, Ohio, 44106
OSU Brain and Spine Hospital ( Site 0016)
Columbus, Ohio, 43210
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)
Corvallis, Oregon, 97330
Thomas Jefferson University - Clinical Research Institute ( Site 0006)
Philadelphia, Pennsylvania, 19107
Medical University of South Carolina-Hollings Cancer Center ( Site 0050)
Charleston, South Carolina, 29425
Sanford Cancer Center ( Site 0075)
Sioux Falls, South Dakota, 57104
Greco-Hainsworth Centers for Research ( Site 4034)
Chattanooga, Tennessee, 37421
Thompson Cancer Survival Center ( Site 0097)
Knoxville, Tennessee, 37916
Baptist Cancer Center ( Site 4049)
Memphis, Tennessee, 38120
One Oncology - Tennessee Oncology ( Site 4019)
Nashville, Tennessee, 37203
SCRI Oncology Partners ( Site 7001)
Nashville, Tennessee, 37203
UT Southwestern Medical Center ( Site 0061)
Dallas, Texas, 75390
Inova Schar Cancer Institute ( Site 0003)
Fairfax, Virginia, 22031
Virginia Cancer Specialists (VCS) ( Site 4004)
Fairfax, Virginia, 22031
Swedish Medical Center-Swedish Cancer Institute ( Site 0088)
Seattle, Washington, 98104
Fred Hutchinson Cancer Center ( Site 0002)
Seattle, Washington, 98109
Edwards Comprehensive Cancer Center ( Site 4015)
Huntington, West Virginia, 25701