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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Sacituzumab tirumotecan: Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
Pembrolizumab: Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Cisplatin: Cisplatin is administered as 75 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase
Pemetrexed: Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.
Gemcitabine: Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m\^2 or 1250 mg/m\^2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.
Carboplatin: 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.
Paclitaxel: Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m\^2 or 200 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment.
Rescue medication: Participants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. Rescue medications include antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and granulocyte colony-stimulating factor. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
Study 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).
Eligibility
Primary outcome measure(s)
- Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) — Up to ~ 93 months
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.
Trial sites (270)
| Facility | City | Region | Status |
|---|---|---|---|
| UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060) | Little Rock | Arkansas | Recruiting |
| Highlands Oncology Group-Research Department ( Site 0062) | Springdale | Arkansas | Recruiting |
| Beverly Hills Cancer Center ( Site 0070) | Beverly Hills | California | Recruiting |
| The Angeles Clinic and Research Institute ( Site 0040) | Los Angeles | California | Completed |
| The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079) | Los Angeles | California | Completed |
| UCLA Clinical & Translational Research Center (CTRC) ( Site 0033) | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital Presbyterian ( Site 0096) | Newport Beach | California | Recruiting |
| St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002) | Orange | California | Recruiting |
| San Francisco Oncology Associates ( Site 0066) | San Francisco | California | Recruiting |
| Stamford Hospital ( Site 0083) | Stamford | Connecticut | Recruiting |
| Mayo Clinic in Florida ( Site 0014) | Jacksonville | Florida | Recruiting |
| Mount Sinai Cancer Center ( Site 0038) | Miami Beach | Florida | Recruiting |
| Mid Florida Hematology and Oncology Center ( Site 0018) | Orange City | Florida | Recruiting |
| Piedmont Atlanta Hospital ( Site 4000) | Atlanta | Georgia | Recruiting |
| Emory University School of Medicine-Phase I ( Site 0056) | Atlanta | Georgia | Recruiting |
| Northside Hospital ( Site 0055) | Atlanta | Georgia | Recruiting |
| Centricity Research Columbus Cancer Center ( Site 0005) | Columbus | Georgia | Completed |
| Southeastern Regional Medical Center ( Site 0065) | Newnan | Georgia | Recruiting |
| Lewis Cancer and Research Pavilion ( Site 0063) | Savannah | Georgia | Recruiting |
| Archbold Cancer Center ( Site 0071) | Thomasville | Georgia | Recruiting |
| Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017) | Elmhurst | Illinois | Completed |
| North Shore University Health System ( Site 4014) | Evanston | Illinois | Recruiting |
| Accellacare of Duly ( Site 4005) | Lisle | Illinois | Recruiting |
| Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078) | Naperville | Illinois | Completed |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0089) | Fort Wayne | Indiana | Recruiting |
| Indiana University Health Arnett Cancer Center ( Site 0076) | Lafayette | Indiana | Recruiting |
| Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061) | Edgewood | Kentucky | Recruiting |
| LSU Health Baton Rouge North Clinic ( Site 4003) | Baton Rouge | Louisiana | Recruiting |
| Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080) | Baton Rouge | Louisiana | Recruiting |
| New England Cancer Specialists ( Site 0095) | Westbrook | Maine | Recruiting |
| Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027) | Minneapolis | Minnesota | Recruiting |
| Mayo Clinic - Rochester ( Site 0073) | Rochester | Minnesota | Recruiting |
| Mercy South - David M Sindelar Cancer Center ( Site 0098) | St Louis | Missouri | Recruiting |
| Mercy Research - David C. Pratt Cancer Center ( Site 0006) | St Louis | Missouri | Recruiting |
| Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037) | Reno | Nevada | Recruiting |
| Atlantic Health Morristown Medical Center ( Site 0077) | Morristown | New Jersey | Recruiting |
| Cayuga Medical Center ( Site 0086) | Ithaca | New York | Recruiting |
| University Hospital at Stony Brook ( Site 0054) | Stony Brook | New York | Recruiting |
| White Plains Hospital ( Site 0091) | White Plains | New York | Recruiting |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057) | Fargo | North Dakota | Recruiting |
+ 230 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06312137 on ClinicalTrials.gov ↗ ← All trials in South Korea