NCT06312137

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)

Phase IIIRecruitingMerck Sharp & Dohme LLC

Non Small Cell Lung Cancer
Carcinoma, Non-small-cell Lung
Carcinoma
Lung Neoplasms

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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).

Interventions

BIOLOGICALSacituzumab tirumotecan
BIOLOGICALPembrolizumab
DRUGCisplatin
DRUGPemetrexed
DRUGGemcitabine
DRUGCarboplatin
DRUGPaclitaxel
DRUGRescue medication

Eligibility

Inclusion criteria

Must be at least 18 years old
Confirmed diagnosis of non-small cell lung cancer (NSCLC).
Requires clinical discussion
If HIV-positive, infection must be well controlled on therapy.
Requires clinical discussion
Able to undergo surgery.
Requires clinical discussion

Exclusion criteria

No history of noninfectious lung inflammation (pneumonitis) requiring steroids.
No diagnosis of small cell lung cancer (SCLC).
No active inflammatory bowel disease (IBD).
No chronic systemic steroid therapy above 10mg daily of prednisone equivalent.
Must not have received prior neoadjuvant therapy for current NSCLC.
No severe heart conditions (Class III or IV heart failure).
Requires clinical discussion
No moderate to severe peripheral neuropathy (Grade 2 or higher).
Requires clinical discussion

Locations

Argentina

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)
Ciudad Autonoma de Buenos Aires, Argentina
Study Coordinator · +541149590200
Hospital Británico de Buenos Aires-Oncology ( Site 0207)
Ciudad Autónoma de Buenos Aires, Argentina
Study Coordinator · +541143096400
Sanatorio Británico-Clinical Oncology Department ( Site 0206)
Rosario, Argentina
Study Coordinator · 5493416575134
Sanatorio Parque ( Site 0205)
Rosario, Argentina
Study Coordinator · 5493416955611
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)
San Miguel de Tucumán, Argentina
Study Coordinator · 543814752113