Treatment for lung cancer using targeted chemotherapy delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of transarterial chemoembolization (TACE) for patients with non-small cell lung cancer or lung metastases that are resistant to standard treatments. The procedure involves injecting chemotherapy directly into the blood supply of the tumor while simultaneously blocking that supply to enhance drug delivery and reduce tumor growth. Patients will undergo imaging assessments to evaluate their response to the treatment over time. The primary goal is to assess the safety and efficacy of this approach in controlling tumor progression.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Franz E Boas, MD — City of Hope Medical Center
• Study coordinator: Franz Edward Boas, MD
• Email: fboas@coh.org
• Phone: 626-218-8708

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.