Study on Trabedersen (OT-101) and Pembrolizumab for Newly Diagnosed Advanced Non-Small Cell Lung Cancer with Positive PD-L1

Sponsor: University of Nebraska

Sponsor score: 40

ClinicalTrials ID:NCT06579196

Provider View

This clinical trial is testing a new combination of drugs, Trabedersen (OT-101) and Pembrolizumab, to see if they are safe and effective for treating adults with certain types of advanced Non-Small Cell Lung Cancer (NSCLC) that have a positive PD-L1 marker.

Patient Parameters

Program Overview

The purpose of this study is to find out if the combination of Trabedersen (OT-101) and Pembrolizumab is safe and can help delay the progression or return of Non-Small Cell Lung Cancer (NSCLC) in adults. The study will also determine the best dose of OT-101 to use with Pembrolizumab. Participants will receive OT-101 through an IV for 4 days every 2 weeks and Pembrolizumab through an IV every 6 weeks.

Description

This clinical trial aims to evaluate the safety and effectiveness of combining Trabedersen (OT-101) with Pembrolizumab in adults with certain types of advanced Non-Small Cell Lung Cancer (NSCLC) that have a positive PD-L1 marker. The study will determine the best dose of OT-101 to use and assess any medical issues participants may experience with this combination.

Participants will receive OT-101 through an IV for 4 days every 2 weeks, requiring clinic visits to start and stop the infusion. Pembrolizumab will be given through an IV every 6 weeks.

In Phase I, the study will adjust the dose of OT-101 to find the safest and most effective amount when used with Pembrolizumab. In Phase II, participants will receive the determined dose of OT-101 with Pembrolizumab until their cancer progresses, returns, or they pass away.

Eligibility Criteria

Inclusion Criteria

  • Be 19 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) with a PD-L1 marker of at least 1%.
  • Have cancer that has spread or cannot be cured with surgery.
  • Have not received any prior treatment for metastatic NSCLC, except for early-stage treatments completed at least six months ago that did not include immunotherapy.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have measurable cancer according to standard criteria.
  • Have adequate organ and bone marrow function, including:
    • Neutrophil count of at least 1,500/mm3.
    • Platelet count of at least 100,000/mm3.
    • Hemoglobin level above 9.0 mg/dL.
    • Creatinine clearance above 60 ml/min/1.73 m2.
    • Total bilirubin level below 1.5 times the upper limit of normal, unless known to have Gilbert's syndrome.
    • Liver enzymes (AST/ALT) within specified limits.
  • Women of childbearing potential must have a negative pregnancy test within 7 days of treatment and agree to use effective contraception during treatment and for 90 days after.
  • Men must agree to use effective contraception during the trial and for 90 days after.
  • Be able to provide informed consent.

Exclusion Criteria

  • Have received any systemic treatments, including investigational drugs, within the last 28 days.
  • Have known allergies to any ingredients in OT101 or Pembrolizumab.
  • Have received radiotherapy within 14 days of the study, except for palliative radiation with a 1-week break.
  • Be pregnant or breastfeeding.
  • Have a history of autoimmune diseases requiring systemic treatment in the past 2 years, except for certain conditions like thyroid replacement or insulin for diabetes.
  • Have uncontrolled systemic diseases that may interfere with the study.
  • Have another active cancer needing treatment, except for certain skin, bladder, or cervical cancers.
  • Have an immunodeficiency diagnosis or be on chronic steroids exceeding a dose equivalent to prednisone 10 mg daily.
  • Have symptomatic brain metastases, unless treated and off steroids.
  • Have psychiatric or substance use issues that would interfere with the study.
  • Be unable to comply with the study requirements.

Locations

FACILITYZIPCITYSTATE
University of Nebraska Medical Center68198OmahaNebraska

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