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Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

StatusActive, Not Recruiting
PhasePhase 2
Started2025-03-20
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
Enrollment closed, study ongoing
2026-08-28
Study Status, Contacts/Locations v25
Study sites38→39
2026-06-25
Study Status, Contacts/Locations v24
Study sites37→38
2026-05-28
Study Status, Contacts/Locations v23
Study sites36→37
2026-05-21
Study Status, Contacts/Locations v22
Study sites34→36
2026-03-27
Study Status, Contacts/Locations v21
Trial sites expanded: 31 → 34 locations
2026-03-06
Study Status, Contacts/Locations v20
Study sites29→31
2026-02-25
Study Status, Contacts/Locations v19
Study sites28→29
2026-02-16
Study Status, Contacts/Locations v18
Study sitescontacts updated at 1 of 28 sites
2026-02-06
Study Status, Contacts/Locations v17
Study sites27→28
2025-12-03
Study Status, Contacts/Locations v16
Study sites26→27
2025-10-28
Study Status, Contacts/Locations v15
Study sitescontacts updated at 3 of 26 sites
2025-10-02
Study Status, Contacts/Locations v14
Study sites25→26
2025-09-23
Study Status, Contacts/Locations v13
Study sites24→25
2025-09-17
Study Status, Contacts/Locations v12
Study sites23→24
2025-09-09
Study Status, Contacts/Locations v11
Study sites19→23
2025-08-27
Study Status, Contacts/Locations v10
Primary completion date2031-11-05→2032-02-06
Completion date2032-02-07→2032-02-06
Study sites11→19
2025-07-14
Study Status, Arms and Interventions, Eligibility v9
InterventionsAcetaminophen (or equivalent) (Drug), Antihistamine (Drug), Carboplatin (Drug), Cisplatin (Drug), Dexamethasone (or equivalent) (Drug)…→Acetaminophen (or equivalent) (Drug), Carboplatin (Drug), Cisplatin (Drug), Dexamethasone (or equivalent) (Drug), Gemcitabine (Drug), H1…
Eligibility criteria+7 characters
[...] rome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. Has ac [...]
2025-07-04
Study Status, Contacts/Locations v8
Study sites9→11
2025-06-17
Study Status, Contacts/Locations v7
Study sites8→9
2025-06-11
Study Identification, Study Status, Contacts/Locations v6
Study sites3→8
2025-04-24
Study Status, Contacts/Locations v5
Study sites2→3
2025-04-01
Study Status, Contacts/Locations v4
Start dateestimated 2025-03-14→confirmed 2025-03-20
Study sitescontacts updated at 1 of 2 sites
2025-03-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites0→2
2025-03-04
Study Identification, Study Status v2
Start date2025-03-03→2025-03-14
2025-02-06
Study Status, IPDSharing v1
Re-verified, no change to tracked fields
2025-01-17
Original filing
Merck (MSD)
401 trials monitored
See 24 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
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.
Trial Details
NCT Number NCT06788912
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Lung Neoplasm Malignant
Enrollment 60 participants
Start Date 2025-03-20
Primary Completion 2032-02-06 (estimated)
Study Completion 2032-02-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-28