Recruiting
Phase 3
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
Non Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
Sacituzumab tirumotecanPembrolizumabCisplatinPemetrexedGemcitabineCarboplatinPaclitaxelRescue medication
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
The key inclusion and exclusion criteria include but are not limited to the following:
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) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
* 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
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 (268)
| 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 |
| 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 |
| Hightower Clinical, LLC ( Site 0084) |
Oklahoma City |
Oklahoma |
Recruiting |
+ 228 more sites — see the full list on the official registry below.
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