NCT06788912 Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
| NCT ID | NCT06788912 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Lung Neoplasm Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2032-02-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-03-20 with a primary completion date of 2032-02-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) * Able to undergo protocol therapy, including necessary surgery * Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention. * Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis. Exclusion Criteria: * Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Active infection requiring systemic therapy. * Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection. * Known history of human immunodeficiency virus (HIV) infection. * History of allogeneic tissue/solid organ transplant.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT06788912 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Neoplasm Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06788912 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06788912 currently recruiting?
Yes, NCT06788912 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT06788912 trial being conducted?
This trial is being conducted at Daphne, United States, Santa Barbara, United States, Lone Tree, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT06788912 clinical trial?
NCT06788912 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 60 participants.