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Lung Non-Small Cell CarcinomaPhase 2NCT05672108

Phase II Trial of Lung Chemoemobolization

A Phase 2 study testing Computed Tomography, Ethiodized Oil and Mitomycin in people with Lung Non-Small Cell Carcinoma and Mediastinal Neoplasm, run by City of Hope Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Ethiodized Oil and Mitomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
12 May 2023to 28 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 23Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Franz Edward Boas, MD contact

626-218-8708

fboas@coh.org

United States2 sites, 2 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Franz E. Boas, 626-218-8708, fboas@coh.org

    Franz E. Boas

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Stephen B. Solomon, MD, 212-639-5012, solomons@mskcc.org

    Stephen B. Solomon, MD

    Recruiting

Other trials in United States

About this study

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor\'s blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine safety and efficacy (local progression free survival) of chemoembolization of lung cancer that is chemorefractory, unresectable, and unablatable.

OUTLINE:

Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on computed tomography (CT) scans.

Being tested
Computed Tomography, Ethiodized Oil, Mitomycin, Transarterial Chemoembolization, Tris-acryl Gelatin Microspheres
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Mediastinal Neoplasms, Pleural Neoplasms, Colonic Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Ethiodized OilDrug

    Also called Ethiodol, Iodized Oil, Lipiodol

    Given IA

  • MitomycinDrug

    Also called Ametycine, Jelmyto, MITO, Mito-C

    Given IA

  • Transarterial ChemoembolizationProcedure or surgery

    Also called TACE

    Undergo TACE

  • Tris-acryl Gelatin MicrospheresDevice

    Also called Embospheres, TAGM, Trisacryl Gelatin Microspheres

    Given IA

Study groups in NCT05672108
Study groupRoleWhat they receive
Lung chemoembolizationExperimentalPatients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.
Receives: Procedure: Computed Tomography; Drug: Ethiodized Oil; Drug: Mitomycin; Procedure: Transarterial Chemoembolization; Device: Tris-acryl Gelatin Microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local progression free survival

    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.

    Measured: 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

  2. Incidence of adverse events

    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.

    Measured: Up to 3 months after the last chemoembolization procedure

Secondary outcomes (6)

  1. Objective response rate (best response)

    Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.

    Measured: Within 3 months of treatment

  2. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 9 months

  3. Progression-free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 9 months

  4. Bronchial versus pulmonary artery blood supply

    Percentage of treatments where target tumors were supplied by bronchial artery, non-bronchial systemic artery, or pulmonary artery, based on catheter angiography. Confidence intervals of proportions will be estimated using the equal-tailed Jeffreys prior interval.

    Measured: Up to 9 months

  5. Lipiodol retention in treated tumors

    Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.

    Measured: 4-6 weeks post-procedure

  6. Growth of TACE targeted lesions versus non-TACE targeted lesions

    Percentage change in size (largest diameter) of the largest treated, compared to the largest untreated tumor will be evaluated using the Wilcoxon signed-rank test.

    Measured: 4-6 weeks post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start12 May 2023
  3. Primary completion28 Oct 2027 (estimated)
  4. Study completion28 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672108
Sponsor's protocol ID
22067
Other IDs
P30CA033572, NCI-2022-10436, 22067
Status last verified
Mar 2026
First submitted
3 Jan 2023
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • Boas FE, Salgia R, Waddington T, Massarelli E, Park JJ, Kessler J, Frankel P, Alexander ES, Solomon SB. Phase II Trial of Lung Chemoembolization. J Vasc Interv Radiol. 2023 Dec;34(12):2090-2092. doi: 10.1016/j.jvir.2023.08.006. Epub 2023 Aug 21. No abstract available.

    PubMed 37611799

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Ethiodized Oil and Mitomycin in people with Lung Non-Small Cell Carcinoma and Mediastinal Neoplasm, run by City of Hope Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Franz Edward Boas, MD (626-218-8708, fboas@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local progression free survival (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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