RECRUITING

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

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Conditions

Non-small Cell Lung CancerNewly DiagnosedPD-L1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to: 1) evaluate the safety and recommended dose of the drug OT-101/Trabedersen when combined with Pembrolizumab and 2) determine the efficacy of the combination therapy in adults with certain types of Non-Small Cell Lung Cancer. The main question(s) it aims to answer are: * What medical problems to participants have when taking OT101 together with Pembrolizumab? * What is the correct dose of OT-101 to use when evaluating the safety and efficacy of the combination therapy? * Does the combination therapy delay progression or relapse of the participant\'s Non-Small Cell Lung Cancer? Participants will: * Receive intravenous OT-101/Trabedersen for 4 days once every 2 weeks. Clinic visits are required to receive and disconnect the infusion. * Receive intravenous Pembrolizumab once every 6 weeks.

Official Title

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

Quick Facts

Study Start:2025-05-12
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06579196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 19 years
  2. * Histologically/cytologically proven diagnosis of non-small cell lung cancer (NSCLC) with a PD-L1 of at least 1%
  3. * Metastatic disease or disease not amenable for curative intent therapy
  4. * No prior treatment for metastatic NSCLC. Early-stage disease therapy acceptable if completed at least six months prior and did not include immunotherapy.
  5. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. * Measurable disease by RECIST criteria
  7. * Adequate organ and marrow function as defined below:
  8. * Absolute neutrophil count ≥1,500/mm3
  9. * Platelets ≥100,000/mm3
  10. * Hemoglobin \>9.0 mg/dL
  11. * Creatinine clearance \> 60 ml/min/1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  12. * 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
  13. * 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
  14. * 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
  15. * Male participants must agree to use effective contraception during the trial \& for 90 days after end of treatment
  16. * Able to give informed consent
  1. * Received any systemic treatments including investigational agents within the last 28 days
  2. * Known hypersensitivity to any of the excipients of OT101 or pembrolizumab
  3. * Received radiotherapy within 14 days of the study intervention. Palliative radiation is allowed during the study with a 1-week washout
  4. * Pregnant or breast-feeding women
  5. * 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.
  6. * Uncontrolled systemic diseases that in the opinion of the investigator may interfere with the protocol activities
  7. * 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.
  8. * Immunodeficiency diagnosis or receiving chronic steroids that exceed a dose equivalent to prednisone 10 mg daily
  9. * Symptomatic brain metastases. Asymptomatic metastases or having received treatment for brain metastases and are off steroid therapy is acceptable.
  10. * Known psychiatric or substance use that would interfere with the study requirements
  11. * Inability to co-operate with the requirements of the protocol

Contacts and Locations

Study Contact

Samuel P Anderson, BS
CONTACT
402-559-1250
samuanderson@unmc.edu
Taylor A Johnson, MA
CONTACT
402-559-4596
taylora.johnson@unmc.edu

Principal Investigator

Omar Abughanimeh, MBBS
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Omar Abughanimeh, MBBS, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12
Study Completion Date2029-02

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

  • Newly Diagnosed
  • PD-L1

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer