Phase II Trial of Lung Chemoemobolization

Phase 2

Recruiting

• Conditions: Lung Non-Small Cell Carcinoma; Mediastinal Neoplasm; Pleural Neoplasm; Lung Metastases From Any Primary; Endobronchial Metastases; Colon Cancer; Sarcoma
• Interventions: Procedure: Computed Tomography; Drug: Ethiodized Oil; Drug: Mitomycin; Procedure: Transarterial Chemoembolization; Device: Tris-acryl Gelatin Microspheres

• Registration Number: NCT05672108
• Lead Sponsor: City of Hope Medical Center

Brief 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 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.

Detailed Description

PRIMARY OBJECTIVE:

I. 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.

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Start: 2023-05-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-10-28
• Study Completion: 2026-10-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung chemoembolization	Computed Tomography	Patients 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.
Lung chemoembolization	Ethiodized Oil	Patients 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.
Lung chemoembolization	Transarterial Chemoembolization	Patients 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.
Lung chemoembolization	Tris-acryl Gelatin Microspheres	Patients 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.
Lung chemoembolization	Mitomycin	Patients 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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up 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.
Local progression free survival	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	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.

Secondary Outcome Measures

Name	Time	Method
Lipiodol retention in treated tumors	4-6 weeks post-procedure	Correlation between lipiodol retention and change in tumor size will be evaluated using Spearman's rank correlation coefficient (rho) and Spearman's test.
Growth of TACE targeted lesions versus non-TACE targeted lesions	4-6 weeks post-procedure	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.
Progression-free survival	Up to 9 months	Will be estimated using the Kaplan-Meier method.
Overall survival	Up to 9 months	Will be estimated using the Kaplan-Meier method.
Objective response rate (best response)	Within 3 months of treatment	Evaluated on a per-treatment basis, using RECIST version 1.1 criteria.
Bronchial versus pulmonary artery blood supply	Up to 9 months	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.

Trial Locations

Locations (2)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States