Can blocking TGF-Beta 2 boost immunotherapy in lung cancer?

NCT ID NCT06579196

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether adding an experimental drug called trabedersen (OT-101) to standard pembrolizumab helps adults with newly diagnosed advanced non-small cell lung cancer. Trabedersen blocks a protein called TGF-beta 2, which may help the immune system fight the cancer. Participants receive trabedersen by IV for four days every two weeks and pembrolizumab by IV every six weeks. The trial measures side effects, finds the best dose, and tracks how long participants live without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trabedersen (OT-101), an experimental drug that blocks TGF-beta 2, given with pembrolizumab
What this could lead to
If the combination works, it could offer a new way to treat advanced non-small cell lung cancer that has not yet received treatment.
What could go wrong
This is an early-phase trial with about 45 participants, so safety and dosing are still being worked out. The combination may not slow the cancer, and adding trabedersen could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

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