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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
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Enrollment
780
Timeline
Apr 2024 → Oct 2034
About This Study
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 Criteria
Inclusion Criteria
- 1Has 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
- 2Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
- 3Is able to undergo surgery based on opinion of investigator after consultation with surgeon
- 4Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
- 5Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
- 6Applies 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
- 7Applies 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
- 8Participants 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
- 9Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- 10Participants 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
- 11Participants 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
- 1Has one of the following tumor locations/types:
- 2NSCLC involving the superior sulcus
- 3Large cell neuro-endocrine cancer (LCNEC)
- 4Sarcomatoid tumor
- 5Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
- 6Has Grade ≥2 peripheral neuropathy
- 7Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- 8Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- 9Has 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
- 10Has received prior neoadjuvant therapy for their current NSCLC diagnosis
- 11Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- 12Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- 13Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- 14Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- 15Has 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
- 16Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- 17Has an active autoimmune disease that has required systemic treatment in the past 2 years
- 18Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- 19Has an active infection requiring systemic therapy
- 20Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- 21Has 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
- 22Has a history of allogeneic tissue/solid organ transplant
- 23Has not adequately recovered from major surgery or have ongoing surgical complications
- 24Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy
Locations
251 sites participating in this study
Emory University School of Medicine-Phase I ( Site 0056)
Atlanta, Georgia 30322
Study Coordinator
UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock, Arkansas 72205
Study Coordinator
Highlands Oncology Group-Research Department ( Site 0062)
Springdale, Arkansas 72762
Study Coordinator
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →