Phase II Lung Chemoembolization for Lung Cancer and Metastases

This Phase II study is testing a treatment called transarterial chemoembolization (TACE) for people with non-small cell lung cancer or lung metastases (cancer that has spread to the lungs). TACE involves injecting chemotherapy, specifically Mitomycin, along with Ethiodized Oil and Tris-acryl Gelatin Microspheres, directly into the blood vessels feeding the tumors in your lungs. This process aims to deliver a high dose of chemotherapy to the tumor while also cutting off its blood supply. The study is looking at how well this treatment controls the cancer in the treated area and any side effects you might experience. You may be able to join if you have lung cancer or lung metastases that are growing despite other treatments, or if you can't tolerate other treatments, and if your tumors can't be removed by surgery or other procedures. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a Phase II interventional study, meaning all 30 participants will receive the same treatment. It is designed to evaluate the safety and effectiveness of lung chemoembolization.
What's involved
You will undergo the transarterial chemoembolization (TACE) procedure. Your response to treatment will be checked using Computed Tomography (CT) scans.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long it takes for the cancer to progress in the treated area or for death to occur, up to 6 months. Adverse events will be monitored for up to 3 months after your last chemoembolization procedure.

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

NCT05672108

Phase II Trial of Lung Chemoemobolization

Recruiting
PHASE2Ages 18+InterventionalTreatment
City of Hope Medical Center
~30 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Computed TomographyEthiodized OilMitomycinTransarterial ChemoembolizationTris-acryl Gelatin Microspheres

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local progression free survival
Measured over Time from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months
+1 more outcome measured
Lung Non-Small Cell Carcinoma
Mediastinal Neoplasm
Pleural Neoplasm
Lung Metastases From Any Primary
Endobronchial Metastases
Colon Cancer
Sarcoma
2 sites across 2 states
California1
New York1
  • Franz E Boas, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy
Lung-dominant disease (majority of active tumor volume is in the chest)
At least 18 years old

Exclusion

Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Oxygen saturation \< 92% on room air
Forced expiratory volume in 1 second (FEV1) \< 60%
No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all \< 1 cm)
Life expectancy \< 6 months
Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging \[MRI\], or direct pressure measurement)
Recent pulmonary embolism (within 3 months)
Pulmonary arteriovenous malformation
Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
Symptomatic heart failure (American College of Cardiology \[ACC\]/American Heart Association \[AHA\] stage C or D)
Left bundle branch block (contraindication to pulmonary angiography)
Renal failure (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m\^2)
Pregnancy or intent to become pregnant
Breast feeding
Altered mental status that would interfere with consent or follow-up
Platelets \< 50,000 (after transfusion, if needed)
International normalized ratio (INR) \> 2 (after transfusion, if needed)
Hemoglobin \< 7 (after transfusion, if needed)
Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)
Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
Allergy to lipiodol or mitomycin
Allergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedication
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety
  • Local progression free survivalTime from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months

    Progression is determined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. criteria, compared to the scan immediately prior to treatment of that territory, using the 2 largest measurable lesions per treated territory. Local progression-free survival will be estimated using the Kaplan-Meier method.

  • Incidence of adverse eventsUp to 3 months after the last chemoembolization procedure

    Complications will be classified using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The rate of complications can be estimated with a standard error of less than 10%. Further, any complication that occurs with a 10% incidence will be observed with greater than 95% probability.