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

NCT06579196 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-07-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Trabedersen

Trabedersen (OT-101) is a synthetic antisense oligodeoxynucleotide that specifically inhibits the production of Transforming growth factor-beta 2 (TGF-β2).

DRUG

Pembrolizumab

Pembrolizumab is a humanized anti-programmed death (PD-1) monoclonal antibody.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Omar Abughanimeh, MBBS · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2028-03-31
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579196 on ClinicalTrials.gov