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NCT06312137 · ClinicalTrials.gov registry record · Phase 3
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 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 780
- Enrollment target
- 20
- Study locations
NCT06312137 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 780 participants, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT06312137, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 780 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- BIOLOGICAL Sacituzumab tirumotecan
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
Study Locations (20)
California
- Beverly Hills Cancer Center ( Site 0070) - Beverly Hills
- The Angeles Clinic and Research Institute ( Site 0040) - Los Angeles
- The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079) - Los Angeles
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0033) - Los Angeles
- Hoag Memorial Hospital Presbyterian ( Site 0096) - Newport Beach
- San Francisco Oncology Associates ( Site 0066) - San Francisco
Georgia
- Emory University School of Medicine-Phase I ( Site 0056) - Atlanta
- Northside Hospital ( Site 0055) - Atlanta
- Centricity Research Columbus Cancer Center ( Site 0005) - Columbus
- Southeastern Regional Medical Center ( Site 0065) - Newnan
- Lewis Cancer and Research Pavilion ( Site 0063) - Savannah
- Archbold Cancer Center ( Site 0071) - Thomasville
Florida
- Mayo Clinic in Florida ( Site 0014) - Jacksonville
- Mount Sinai Cancer Center ( Site 0038) - Miami Beach
- Mid Florida Hematology and Oncology Center ( Site 0018) - Orange City
Arkansas
- UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060) - Little Rock
- Highlands Oncology Group-Research Department ( Site 0062) - Springdale
Illinois
- Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017) - Elmhurst
- Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078) - Naperville
Connecticut
- Stamford Hospital ( Site 0083) - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2034-10-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06312137
The ClinicalTrials.gov registry entry for NCT06312137 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (19% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Sacituzumab tirumotecan is the first listed.
NCT06312137 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT06312137 about?
NCT06312137 is a clinical study titled "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)". 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 mono...
What is the current status of trial NCT06312137?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 780 participants. The study started on 2024-04-03. Estimated completion is 2034-10-23.
What conditions does trial NCT06312137 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06312137?
The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT06312137?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06312137 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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