A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
Summary
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).
Arms & interventions
- BiologicalPembrolizumab
IV Infusion
- DrugCisplatin
IV infusion
- DrugCarboplatin
IV infusion
- DrugPemetrexed
IV infusion
- DrugGemcitabine
IV infusion
- DrugPaclitaxel
IV infusion
- BiologicalIntismeran autogene
IM injection
- 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 ~97 months
Secondary
Overall Survival (OS)
Time frame: Up to ~129 months
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to ~129 months
Disease-Free Survival 2 (DFS2)
Time frame: Up to ~129 months
Lung Cancer Specific Survival (LCSS)
Time frame: Up to ~129 months
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)
Time frame: Baseline and up to ~129 months
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)
Time frame: Baseline and up to ~129 months
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)
Time frame: Baseline and up to ~129 months
Number of participants with ≥1 adverse event (AE)
Time frame: Up to ~129 months
Number of participants discontinuing from study therapy due to AE(s)
Time frame: Up to ~129 months
Eligibility criteria
Study locations (48)
Banner MD Anderson Cancer Center ( Site 0181)
Gilbert, Arizona, 85234
The University of Arizona Cancer Center - North Campus ( Site 0163)
Tucson, Arizona, 85719
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California, 92835
VA Long Beach Healthcare System ( Site 0199)
Long Beach, California, 90822
USC Norris Comprehensive Cancer Center ( Site 0205)
Los Angeles, California, 90033
UCSF Medical Center at Mission Bay ( Site 0178)
San Francisco, California, 94158
University of Colorado Anschutz Medical Campus ( Site 0151)
Aurora, Colorado, 80045
UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs, Colorado, 80909
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
Greeley, Colorado, 80631
Centura Health - St. Anthony North Health Campus ( Site 0189)
Westminster, Colorado, 80023
Yale University School of Medicine ( Site 0201)
New Haven, Connecticut, 06510
Eastern CT Hematology & Oncology Associates ( Site 0202)
Norwich, Connecticut, 06360
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
Fort Lauderdale, Florida, 33316
Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)
Miami, Florida, 33176
Beacon Cancer Care ( Site 0127)
Post Falls, Idaho, 83854
The University of Chicago Medical Center ( Site 0118)
Chicago, Illinois, 60637
Maryland Oncology Hematology (MOH) ( Site 8102)
Rockville, Maryland, 20850
Massachusetts General Hospital ( Site 0136)
Boston, Massachusetts, 02114
Dana Farber Cancer Hospital ( Site 0155)
Boston, Massachusetts, 02215
Ellis Fischel Cancer Center ( Site 0133)
Columbia, Missouri, 65212
Lake Regional Hospital-Cancer Center ( Site 0123)
Osage Beach, Missouri, 65065
Roswell Park Cancer Institute ( Site 0184)
Buffalo, New York, 14263
Hematology-Oncology Associates of CNY ( Site 0164)
East Syracuse, New York, 13057
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)
New York, New York, 10011
Icahn School of Medicine at Mount Sinai ( Site 0116)
New York, New York, 10029
Memorial Sloan Kettering Cancer Center ( Site 0137)
New York, New York, 10065
SUNY Upstate Cancer Center ( Site 0140)
Syracuse, New York, 13210
Montefiore Medical Center ( Site 0160)
The Bronx, New York, 10461
Westchester Medical Center ( Site 0196)
Valhalla, New York, 10595
Novant Health Weisiger Cancer Insititute ( Site 0266)
Charlotte, North Carolina, 28204
Novant Health Forsyth Medical Center ( Site 0166)
Winston-Salem, North Carolina, 27103
University of Cincinnati Medical Center ( Site 0119)
Cincinnati, Ohio, 45219
St. Lukes Hospital and Health Network ( Site 0186)
Bethlehem, Pennsylvania, 18015
Thompson Cancer Survival Center ( Site 0168)
Knoxville, Tennessee, 37916
Elliston Place Medical Oncology & Hematology ( Site 0215)
Nashville, Tennessee, 37203
Texas Oncology - DFW ( Site 8103)
Dallas, Texas, 75246
UT Southwestern Medical Center ( Site 0190)
Dallas, Texas, 75390
Houston Methodist Cancer Center ( Site 0191)
Houston, Texas, 77030
MD Anderson Cancer Center ( Site 0150)
Houston, Texas, 77030
Memorial Hermann Cancer Center ( Site 0172)
Houston, Texas, 77030
Michael E. DeBakey VA Medical Center ( Site 0197)
Houston, Texas, 77030
O'Quinn Medical Tower at McNair Campus ( Site 0131)
Houston, Texas, 77030
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)
Tyler, Texas, 75701
Virginia Cancer Specialists ( Site 0167)
Fairfax, Virginia, 22031
Virginia Oncology Associates (VOA) ( Site 8101)
Norfolk, Virginia, 23502
VCU Health Adult Outpatient Pavillion ( Site 0193)
Richmond, Virginia, 23219
Swedish Cancer Institute ( Site 0143)
Seattle, Washington, 98104
Virginia Mason Franciscan Health - St. Michael Cancer Center ( Site 0192)
Silverdale, Washington, 98383