Treatment for lung cancer using targeted chemotherapy delivery
Phase II Trial of Lung Chemoemobolization
This study is testing a new way to deliver chemotherapy directly to lung tumors in patients with hard-to-treat lung cancer to see if it helps control tumor growth better than standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Duarte, California and 1 other locations) |
| Trial ID | NCT05672108 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with lung cancer or lung metastases that are progressing despite systemic therapy and are not suitable for surgical or ablative treatments.
Not a fit: Patients with poor performance status, significant respiratory issues, or those without measurable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with advanced lung cancer who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promising results with similar approaches using TACE for various cancers, indicating potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Duarte, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.