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PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer

StatusRecruiting
PhasePhase 1
Started2022-11-21
View on ClinicalTrials.gov ↗
This phase I trial studies the side effects and best dose of PBF-1129 in combination with nivolumab in treating patients with non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as PBF-1129 and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Amendment record

Amended 8 times since 2022-02-01; most recent filed 2026-02-04. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-02-04
Amendment Study Status, Oversight v8
2025-09-03
Amendment Study Identification, Study Status, Conditions, Eligibility, Contacts/Locations v7
2025-03-18
Amendment Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v6
2024-03-14
Amendment Suspended→Recruiting Study Status, Contacts/Locations v5
2024-02-02
Amendment Recruiting→Suspended Study Status, Eligibility, Contacts/Locations v4
2023-02-01
Amendment Study Status v3
2022-10-13
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
2022-09-29
Amendment Study Status, Contacts/Locations v1
2022-02-01
Original filing
Trial Details
NCT Number NCT05234307
Lead Sponsor Dwight Owen
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Enrollment 30 participants
Start Date 2022-11-21
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-06