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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: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
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 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
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 |
What NCT06312137 shows while recruiting
NCT06312137 is an interventional study that assigns participants to a tested intervention. The registered 780 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (20% higher).
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 names 20 study sites across 6 states, led by 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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Where NCT06312137's enrollment target sits among peer trials
780 36th of 454 higher than 418 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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