Study

Overview

Official Title: 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

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).

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

780

Study Start Date:

April 2024

Estimated Study Completion Date:

October 2034

Estimated Primary Completion Date:

February 2034

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

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) 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

Locations

United States Toll Free Number 1-800-770-4674

Little Rock, Arkansas, 72205
Springdale, Arkansas, 72762
Beverly Hills, California, 90211
Los Angeles, California, 90025
Los Angeles, California, 90025
Los Angeles, California, 90095
San Francisco, California, 94115
Stamford, Connecticut, 06902
Miami Beach, Florida, 33140
Orange City, Florida, 32763
Atlanta, Georgia, 30322
Atlanta, Georgia, 30342
Newnan, Georgia, 30265
Savannah, Georgia, 31405
Thomasville, Georgia, 31792
Fort Wayne, Indiana, 46845
Lafayette, Indiana, 47904
Edgewood, Kentucky, 41017
Baton Rouge, Louisiana, 70808
Minneapolis, Minnesota, 55407
St. Louis, Missouri, 63141
Reno, Nevada, 89502
Morristown, New Jersey, 07960
Ithaca, New York, 14850
Stony Brook, New York, 11794
Fargo, North Dakota, 58122
Portland, Oregon, 97239
Lancaster, Pennsylvania, 17601
Charleston, South Carolina, 29425
Sioux falls, South Dakota, 57104
Sioux Falls, South Dakota, 57105
Knoxville, Tennessee, 37920
Salt Lake City, Utah, 84112-5500

Canada Study Coordinator 5148908000x30921

Results

No Study Results Posted

Study Detail

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)

Overview

Eligibility

CRITERIA

Locations

Results