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Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC

StatusRecruiting
PhasePhase 2
Started2025-06-13
View on ClinicalTrials.gov ↗

Amendment history

2026-08-25
Study Status, Contacts/Locations v13
Trial sites expanded: 8 → 11 locations
2026-07-29
Study Status, Contacts/Locations v12
Study sites6→7
2026-07-02
Study Status, Contacts/Locations v11
Study sites5→6
2026-04-01
Study Status, Contacts/Locations v10
Study sites4→5
2026-02-26
Study Status, Contacts/Locations v9
Study sites2→4
Show 8 earlier versions
2026-01-26
Study Status, Contacts/Locations v8
Study sites1→2
2025-12-02
Study Status v7
Start date2025-01-21→2025-06-13
2025-08-28
2 amendments v5-v6
2 re-verifications since 2025-05-05, no change to tracked fields
2025-02-04
Study Status v4
Start dateestimated 2025-01→confirmed 2025-01-21
2025-01-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-01-21
Study Status, Study Design v2
Enrollment target24→318
2025-01-09
Study Status, Conditions, Arms and Interventions, Eligibility v1
Eligibility criteria-2,749 characters
Cohort 1 Inclusion Criteria: Be willing and able to provide written i [...] or participants who have ≤Grade 2 neuropathy are eligible. Adequate organ function. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female [...] Adequate organ function. Female subjects of childbearing pot [...]
2024-12-17
Original filing
This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.
Trial Details
NCT Number NCT06745882
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Merck Sharp & Dohme LLC, Foundation Medicine, Go-2 Lung
Conditions Non-small Cell Lung Cancer
Enrollment 318 participants
Start Date 2025-06-13
Primary Completion 2030-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-21