A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Purpose
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).
Condition
- Non Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines - Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy - Is able to undergo surgery based on opinion of investigator after consultation with surgeon - Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy - Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology. - Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period - Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization - Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral 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 at screening - Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention
Exclusion Criteria
- Has one of the following tumor locations/types: - NSCLC involving the superior sulcus - Large cell neuro-endocrine cancer (LCNEC) - Sarcomatoid tumor - Diagnosis of SCLC or, for mixed tumors, presence of small cell elements - Has Grade ≥2 peripheral neuropathy - Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention - Has received prior neoadjuvant therapy for their current NSCLC diagnosis - Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention - Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration - Has a 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 the first dose of study medication - Has a known additional malignancy that is progressing or has required active treatment within the past 5 years - Has an active autoimmune disease that has required systemic treatment in the past 2 years - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has an active infection requiring systemic therapy - Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection - Has a history of allogeneic tissue/solid organ transplant - Has not adequately recovered from major surgery or have ongoing surgical complications - Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a multi site study
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Pembrolizumab + Sacituzumab tirumotecan |
Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks). |
|
Active Comparator Pembrolizumab |
Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks). |
|
Recruiting Locations
UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Study Coordinator
601-278-6499
Study Coordinator
601-278-6499
Highlands Oncology Group-Research Department ( Site 0062)
Springdale 4132093, Arkansas 4099753 72762
Springdale 4132093, Arkansas 4099753 72762
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Beverly Hills Cancer Center ( Site 0070)
Beverly Hills 5328041, California 5332921 90211
Beverly Hills 5328041, California 5332921 90211
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
The Angeles Clinic and Research Institute ( Site 0040)
Los Angeles 5368361, California 5332921 90025
Los Angeles 5368361, California 5332921 90025
Contact:
Study Coordinator
310-582-7900
Study Coordinator
310-582-7900
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
Los Angeles 5368361, California 5332921 90025
Los Angeles 5368361, California 5332921 90025
Contact:
Study Coordinator
310-582-7900
Study Coordinator
310-582-7900
San Francisco Oncology Associates ( Site 0066)
San Francisco 5391959, California 5332921 94115
San Francisco 5391959, California 5332921 94115
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Stamford Hospital ( Site 0083)
Stamford 4843564, Connecticut 4831725 06904
Stamford 4843564, Connecticut 4831725 06904
Contact:
Study Coordinator
203-358-8879
Study Coordinator
203-358-8879
Mount Sinai Cancer Center ( Site 0038)
Miami Beach 4164143, Florida 4155751 33140
Miami Beach 4164143, Florida 4155751 33140
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Mid Florida Hematology and Oncology Center ( Site 0018)
Orange City 4167055, Florida 4155751 32763
Orange City 4167055, Florida 4155751 32763
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Emory University School of Medicine-Phase I ( Site 0056)
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Contact:
Study Coordinator
404-778-1900
Study Coordinator
404-778-1900
Northside Hospital ( Site 0055)
Atlanta 4180439, Georgia 4197000 30342
Atlanta 4180439, Georgia 4197000 30342
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Southeastern Regional Medical Center ( Site 0065)
Newnan 4212684, Georgia 4197000 30265
Newnan 4212684, Georgia 4197000 30265
Contact:
Study Coordinator
770-400-6000
Study Coordinator
770-400-6000
Lewis Cancer and Research Pavilion ( Site 0063)
Savannah 4221552, Georgia 4197000 31405
Savannah 4221552, Georgia 4197000 31405
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Archbold Cancer Center ( Site 0071)
Thomasville 4226348, Georgia 4197000 31792
Thomasville 4226348, Georgia 4197000 31792
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Parkview Research Center at Parkview Regional Medical Center ( Site 0089)
Fort Wayne 4920423, Indiana 4921868 46845
Fort Wayne 4920423, Indiana 4921868 46845
Contact:
Study Coordinator
260-266-6626
Study Coordinator
260-266-6626
Indiana University Health Arnett Cancer Center ( Site 0076)
Lafayette 4922462, Indiana 4921868 47904
Lafayette 4922462, Indiana 4921868 47904
Contact:
Study Coordinator
765-838-6885
Study Coordinator
765-838-6885
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
Edgewood 4290873, Kentucky 6254925 41017
Edgewood 4290873, Kentucky 6254925 41017
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)
Baton Rouge 4315588, Louisiana 4331987 70808
Baton Rouge 4315588, Louisiana 4331987 70808
Contact:
Study Coordinator
225-765-7956
Study Coordinator
225-765-7956
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55407
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Mercy Research - David C. Pratt Cancer Center ( Site 0006)
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
Reno 5511077, Nevada 5509151 89502
Reno 5511077, Nevada 5509151 89502
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Atlantic Health Morristown Medical Center ( Site 0077)
Morristown 5101427, New Jersey 5101760 07960
Morristown 5101427, New Jersey 5101760 07960
Contact:
Study Coordinator
973-971-7000
Study Coordinator
973-971-7000
Cayuga Medical Center ( Site 0086)
Ithaca 5122432, New York 5128638 14850
Ithaca 5122432, New York 5128638 14850
Contact:
Study Coordinator
607-277-4341
Study Coordinator
607-277-4341
Stony Brook University-Cancer Center ( Site 0054)
Stony Brook 5139865, New York 5128638 11794
Stony Brook 5139865, New York 5128638 11794
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Oregon Health and Science University ( Site 0052)
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
Lancaster 5197079, Pennsylvania 6254927 17601
Lancaster 5197079, Pennsylvania 6254927 17601
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Sanford Cancer Center ( Site 0053)
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Avera Cancer Institute- Research ( Site 0090)
Sioux Falls 5231851, South Dakota 5769223 57105
Sioux Falls 5231851, South Dakota 5769223 57105
Contact:
Study Coordinator
605-322-3295
Study Coordinator
605-322-3295
University of Tennessee Medical Center Knoxville ( Site 0082)
Knoxville 4634946, Tennessee 4662168 37920
Knoxville 4634946, Tennessee 4662168 37920
Contact:
Study Coordinator
865-305-9000
Study Coordinator
865-305-9000
Millennium Research & Clinical Development ( Site 0039)
Houston 4699066, Texas 4736286 77090
Houston 4699066, Texas 4736286 77090
Contact:
Study Coordinator
888-577-8839
Study Coordinator
888-577-8839
Huntsman Cancer Institute ( Site 0042)
Salt Lake City 5780993, Utah 5549030 84112-5500
Salt Lake City 5780993, Utah 5549030 84112-5500
Contact:
Study Coordinator
801-587-7000
Study Coordinator
801-587-7000
More Details
- NCT ID
- NCT06312137
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC