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)

ConditionNon Small Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorMerck Sharp & Dohme LLC

About this trial

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

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

Sacituzumab tirumotecan
Pembrolizumab
Cisplatin
Pemetrexed
Gemcitabine
Carboplatin
Paclitaxel
Rescue medication

Treatment groups

780 Participants

are divided into 2 treatment groups

Locations

266

Argentina

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)C1199ABB, Ciudad Autonoma de Buenos AiresBuenos Aires, Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0207)C1280AEB, Ciudad Autónoma de Buenos AiresBuenos Aires, Argentina

Sanatorio Británico-Clinical Oncology Department ( Site 0206)S2000CVB, RosarioSanta Fe Province, Argentina

Sanatorio Parque ( Site 0205)S2000DSV, RosarioSanta Fe Province, Argentina

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov