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)
Active Date:
October 01, 2024
IRB Number:
MK2870-019
Condition/Disease:
Lung Cancer
Lead Researcher:
Maria Quejada, MD
Location:
Nancy Knowles Cancer Center - Elmhurst
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).
Sponsor: Merck Sharp & Dohme
https://clinicaltrials.gov/ct2/show/record/NCT06312137
Eligibility:
Inclusion Criteria includes:
Has confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]).
Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy.
Is able to undergo surgery based on opinion of investigator after consultation with surgeon.
Exclusion Criteria includes:
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 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.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 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.
Time Commitment:
Approx. 5-10 years
Status:
Accepting Participants
Current Trial Type:
Interventional
Phase:
III
Contact Name:
Jessica Schnase, Mgr Cancer Research
Phone:
630-646-6072
Fax:
630-646-6074
Alternate Phone:
630-646-6073