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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 NCT06312137

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.

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NCT06312137
Phase 3
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06312137
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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

Study Focus

Sacituzumab tirumotecan

Interventional

biological

Sponsor & Location

Merck Sharp & Dohme LLC

Orange City,Haifa,Jerusalem,Petah Tikva,Tainan, Israel,Taiwan,United States of America

Timeline & Enrollment

Phase 3

Apr 03, 2024

Oct 23, 2034

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 lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06312137

Non-Device Trial