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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)
NCT06312137 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06312137 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06312137?
The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06312137?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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