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Trabedersen and Pembrolizumab for Advanced NSCLC

This study is testing two drugs, Trabedersen (OT-101) and Pembrolizumab, for people with newly diagnosed advanced non-small cell lung cancer (NSCLC) that has a PD-L1 level of at least 1%. Trabedersen works by blocking a protein called TGF-beta 2, and Pembrolizumab is an immunotherapy that targets PD-1. The main goals are to find a safe dose of Trabedersen when given with Pembrolizumab, and to see if this combination can delay the cancer from growing or coming back. You would receive Trabedersen intravenously (through a vein) for 4 days every two weeks, and Pembrolizumab intravenously every six weeks. The study plans to enroll 45 participants.

Study design
This is an interventional study with two phases. Phase I focuses on finding the right dose, and Phase II will evaluate how well the treatment works. It aims to enroll 45 participants.
What's involved
You would receive intravenous Trabedersen for 4 days every two weeks, requiring clinic visits for infusion. You would also receive intravenous Pembrolizumab once every six weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will measure progression-free survival (how long you live without the cancer getting worse) at 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06579196

Trabedersen (OT-101) With Pembrolizumab for Newly Diagnosed Advanced NSCLC and Positive PD-L1

Recruiting
PHASE1Ages 19+InterventionalTreatment
University of Nebraska
~45 participants
Updated 2025-07-24 on ClinicalTrials.gov
What's tested:TrabedersenPembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Dose Finding
Measured over 18 months
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer

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Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Omar Abughanimeh, MBBS · PRINCIPAL_INVESTIGATOR · University of Nebraska

Who to contact

Samuel P Anderson, BS
[email protected]
402-559-1250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 19 years
Histologically/cytologically proven diagnosis of non-small cell lung cancer (NSCLC) with a PD-L1 of at least 1%
Metastatic disease or disease not amenable for curative intent therapy
No prior treatment for metastatic NSCLC. Early-stage disease therapy acceptable if completed at least six months prior and did not include immunotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Measurable disease by RECIST criteria
Adequate organ and marrow function as defined below:
Absolute neutrophil count ≥1,500/mm3
Platelets ≥100,000/mm3
Hemoglobin \>9.0 mg/dL
Creatinine clearance \> 60 ml/min/1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Total serum bilirubin \<1.5 X upper limit of normal (ULN) except if known to have Gilbert's syndrome, then excluded if total bilirubin \>2.5 X ULN
Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 2.5 x ULN; if participant has liver metastases, ≤5x ULN
For females of childbearing potential, negative serum or urine pregnancy test ≤7 days of treatment, \& agree to use effective contraceptive during treatment \& 90 days after end of treatment
Male participants must agree to use effective contraception during the trial \& for 90 days after end of treatment
Able to give informed consent

Exclusion

Received any systemic treatments including investigational agents within the last 28 days
Known hypersensitivity to any of the excipients of OT101 or pembrolizumab
Received radiotherapy within 14 days of the study intervention. Palliative radiation is allowed during the study with a 1-week washout
Pregnant or breast-feeding women
History of autoimmune diseases that required systemic treatment in the past 2 years with agents such as, but not limited to, corticosteroids or immunosuppressive drugs. Thyroid replacement for hypothyroidism, insulin treatment for type I diabetes or corticosteroids adrenal/pituitary insufficiency are allowed.
Uncontrolled systemic diseases that in the opinion of the investigator may interfere with the protocol activities
Known active second malignancy that needs treatment. Exceptions include basal cell or squamous cancers of the skin, bladder or cervical carcinoma in situ, prostate cancer on hormone therapy alone.
Immunodeficiency diagnosis or receiving chronic steroids that exceed a dose equivalent to prednisone 10 mg daily
Symptomatic brain metastases. Asymptomatic metastases or having received treatment for brain metastases and are off steroid therapy is acceptable.
Known psychiatric or substance use that would interfere with the study requirements
Inability to co-operate with the requirements of the protocol

What this trial measures

  • Phase I: Dose Finding18 months

    Dose Limiting toxicity (DLT) and Maximum Tolerated Dose (MTD)

  • Phase II: Progression-Free Survival (PFS)36 months

    Progression-Free Survival (PFS) defined as first therapy until the first documentation of clinical progression, relapse, or death due to any cause. Participants not experiencing an event of interest will be right-censored at last known disease status