Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
Public ClinicalTrials.gov record NCT06788912. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.
Study identification
- NCT ID
- NCT06788912
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab (neoadjuvant) Biological
- Cisplatin Drug
- Gemcitabine Drug
- Pemetrexed Drug
- Sacituzumab tirumotecan Drug
- H1 receptor antagonist Drug
- H2 receptor antagonist Drug
- Acetaminophen (or equivalent) Drug
- Dexamethasone (or equivalent) Drug
- Carboplatin Drug
- Pembrolizumab (adjuvant) Biological
- Paclitaxel Drug
- Steroid mouthwash (dexamethasone or equivalent) Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2025 (Actual)
- Primary completion
- Feb 6, 2032 (Estimated)
- Completion
- Feb 6, 2032 (Estimated)
- Last update posted
- Oct 13, 2026
2025 – 2032
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center (SCC) ( Site 8004) | Daphne | Alabama | 36526 | — |
| Sansum Clinic (Ridley Tree) ( Site 8012) | Santa Barbara | California | 93105 | — |
| Rocky Mountain Cancer Centers (RMCC) ( Site 8011) | Lone Tree | Colorado | 80124 | — |
| Greenebaum Comprehensive Cancer Center ( Site 0402) | Baltimore | Maryland | 21201 | — |
| MedStar Franklin Square Medical Center ( Site 0033) | Baltimore | Maryland | 21237 | — |
| Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006) | Eugene | Oregon | 97401 | — |
| Texas Oncology - Central/South Texas ( Site 8009) | Austin | Texas | 78705 | — |
| Texas Oncology - Northeast Texas ( Site 8005) | Tyler | Texas | 75702 | — |
| Virginia Cancer Specialists (VCS) ( Site 8002) | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06788912, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06788912 live on ClinicalTrials.gov.