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)

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

Sponsors and collaborators