A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
Summary
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Arms & interventions
- BiologicalSacituzumab tirumotecan
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
- BiologicalPembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
- DrugCisplatin
Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase
- DrugPemetrexed
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
- DrugGemcitabine
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.
- DrugCarboplatin
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.
- DrugPaclitaxel
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.
- DrugRescue medication
Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
Outcome measures
Primary
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Time frame: Up to ~ 93 months
Secondary
Overall Survival (OS)
Time frame: Up to ~ 118 months
Distant metastasis-free survival (DMFS) as assessed by investigator
Time frame: Up to ~ 118 months
Disease-Free Survival (DFS) as assessed by investigator
Time frame: Up to ~ 118 months
Lung Cancer Specific Survival (LCSS)
Time frame: Up to ~ 118 months
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to ~ 118 months
Number of Participants Who Discontinue Study Intervention Due to AEs
Time frame: Up to ~ 118 months
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)
Time frame: Baseline and up to ~118 months
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)
Time frame: Baseline and up to ~118 months
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)
Time frame: Baseline and up to ~118 months
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)
Time frame: Baseline and up to ~118 months
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)
Time frame: Baseline and up to ~118 months
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)
Time frame: Baseline and up to ~118 months
Eligibility criteria
Study locations (49)
UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock, Arkansas, 72205
Highlands Oncology Group-Research Department ( Site 0062)
Springdale, Arkansas, 72762
Beverly Hills Cancer Center ( Site 0070)
Beverly Hills, California, 90211
The Angeles Clinic and Research Institute ( Site 0040)
Los Angeles, California, 90025
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
Los Angeles, California, 90025
UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)
Los Angeles, California, 90095
Hoag Memorial Hospital Presbyterian ( Site 0096)
Newport Beach, California, 92663
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)
Orange, California, 92868
San Francisco Oncology Associates ( Site 0066)
San Francisco, California, 94115
Stamford Hospital ( Site 0083)
Stamford, Connecticut, 06902
Mayo Clinic in Florida ( Site 0014)
Jacksonville, Florida, 32224
Mount Sinai Cancer Center ( Site 0038)
Miami Beach, Florida, 33140
Mid Florida Hematology and Oncology Center ( Site 0018)
Orange City, Florida, 32763
Emory University School of Medicine-Phase I ( Site 0056)
Atlanta, Georgia, 30322
Northside Hospital ( Site 0055)
Atlanta, Georgia, 30342
Centricity Research Columbus Cancer Center ( Site 0005)
Columbus, Georgia, 31904
Southeastern Regional Medical Center ( Site 0065)
Newnan, Georgia, 30265
Lewis Cancer and Research Pavilion ( Site 0063)
Savannah, Georgia, 31405
Archbold Cancer Center ( Site 0071)
Thomasville, Georgia, 31792
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)
Elmhurst, Illinois, 60126
Accellacare of Duly ( Site 4005)
Lisle, Illinois, 60532
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)
Naperville, Illinois, 60540
Parkview Research Center at Parkview Regional Medical Center ( Site 0089)
Fort Wayne, Indiana, 46845
Indiana University Health Arnett Cancer Center ( Site 0076)
Lafayette, Indiana, 47904
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
Edgewood, Kentucky, 41017
LSU Health Baton Rouge North Clinic ( Site 4003)
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)
Baton Rouge, Louisiana, 70808
New England Cancer Specialists ( Site 0095)
Westbrook, Maine, 04092
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
Minneapolis, Minnesota, 55407
Mayo Clinic - Rochester ( Site 0073)
Rochester, Minnesota, 55905
Mercy South - David M Sindelar Cancer Center ( Site 0098)
St Louis, Missouri, 63128
Mercy Research - David C. Pratt Cancer Center ( Site 0006)
St Louis, Missouri, 63141
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
Reno, Nevada, 89502
Atlantic Health Morristown Medical Center ( Site 0077)
Morristown, New Jersey, 07960
Cayuga Medical Center ( Site 0086)
Ithaca, New York, 14850
Stony Brook University-Cancer Center ( Site 0054)
Stony Brook, New York, 11794
White Plains Hospital ( Site 0091)
White Plains, New York, 10601
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
Fargo, North Dakota, 58102
Hightower Clinical, LLC ( Site 0084)
Oklahoma City, Oklahoma, 73102
Oregon Health and Science University ( Site 0052)
Portland, Oregon, 97239
Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)
Hershey, Pennsylvania, 17033
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
Lancaster, Pennsylvania, 17601
Saint Joseph's Candler Health System ( Site 4010)
Bluffton, South Carolina, 29910
Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
Charleston, South Carolina, 29425
Sanford Cancer Center ( Site 0053)
Sioux Falls, South Dakota, 57104
Avera Cancer Institute- Research ( Site 0090)
Sioux Falls, South Dakota, 57105
University of Tennessee Medical Center Knoxville ( Site 0082)
Knoxville, Tennessee, 37920
Millennium Research & Clinical Development ( Site 0039)
Houston, Texas, 77090
Huntsman Cancer Institute ( Site 0042)
Salt Lake City, Utah, 84112-5500