Actively Recruiting
PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Led by Dwight Owen · Updated on 2026-02-06
30
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
Sponsors
D
Dwight Owen
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed recurrent or metastatic non-small cell lung cancer of any histology without curative options
- Measurable disease based on RECIST 1.1 criteria
- Prior treatment with standard chemotherapy and immunotherapy, including PD-1/PD-L1 therapies
- No more than three prior lines of metastatic therapy, excluding targeted treatments
- Patients with actionable mutations must have received all approved treatments
- ECOG performance status of 0 or 1
- Absolute neutrophil count ≥ 1,500 /mcL
- Platelets ≥ 100,000 /mcL
- Serum creatinine or creatinine clearance within acceptable limits
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN, or ≤ 5 times ULN if liver metastases present
- Albumin ≥ 2.5 mg/dL
- INR, PT, or aPTT ≤ 1.5 times ULN unless on anticoagulants within therapeutic range
- Life expectancy of at least 3 months
- Willingness to comply with study procedures and swallow pills
- Female patients of childbearing potential must use contraception and have a negative pregnancy test within 7 days prior to treatment
- Ability to understand and sign informed consent
- Availability of recent tumor tissue sample
- Willingness to provide pre-treatment and on-treatment tumor biopsies (dose expansion cohort)
- Willingness to provide blood samples for correlative studies
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment in the past 12 months, except well-controlled skin conditions
- Immunodeficiency or use of immunosuppressive therapy above 10 mg prednisone equivalent within 7 days before treatment
- Known active chronic infections including HIV, active Hepatitis B or C
- Cirrhosis with advanced liver complications or clinically significant ascites
- Symptomatic brain metastases; stable treated brain metastases allowed with restrictions
- Pregnancy or breastfeeding
- Medical or laboratory conditions that could interfere with study participation or results
- Cardiac abnormalities including prolonged QT interval or significant ECG abnormalities
- Prior severe toxicity from checkpoint inhibitor therapy, except resolved grade 3 pneumonitis or stable endocrine toxicities on replacement therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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