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NCT06312137Recruiting

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)

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
Merck Sharp & Dohme LLCPhase 3ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Non Small Cell Lung Cancer
Drug/Device/Intervention
Sacituzumab tirumotecan
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Orange City,Haifa,Jerusalem,Petah Tikva,Tainan, Israel,Taiwan,United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Apr 03, 2024
End date
Oct 23, 2034
Enrollment
780 participants
Primary outcome

Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)

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).

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06312137
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06312137 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 780 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.