RightFit
RecruitingPhase 2

Phase II Trial of Lung Chemoemobolization

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Response to treatment is evaluated on computed tomography (CT) scans."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TACE for non-small cell lung cancer or cancer that has spread to the lungs. TACE puts cancer medicine into an artery feeding a tumor, then blocks its blood supply. It is for adults whose cancer is growing despite whole-body treatment, or who cannot tolerate that treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have tumors in the lungs, lung airways, lung lining, or the space between the lungs.
  • Your cancer is growing despite treatment that works throughout the body, or you cannot tolerate that treatment.
  • Your tumors cannot be treated with surgery, heat or cold treatment, or high-dose radiation.
  • Most of your active cancer is in your chest.

Who can't join

  • You need major help with daily care or spend most waking hours in bed or a chair (ECOG score above 2), or are expected to live less than 6 months.
  • Your oxygen level is below 92% without extra oxygen, your one-second breathing test (FEV1) is below 60%, or you have no treatable tumor that can be measured under study rules.
  • You have high blood pressure in the lung arteries, a lung blood clot within 3 months, abnormal connections between lung arteries and veins, or a lung infection needing treatment within 1 month.
  • You have heart failure with symptoms, a heart electrical problem called left bundle branch block, or kidney failure with a filtering rate (eGFR) below 30.
  • You are pregnant, plan to become pregnant, or are breastfeeding; or changes in your thinking prevent informed consent or follow-up.
  • Even after a transfusion if needed, your platelets (cells that help stop bleeding) are below 50,000, your blood-clotting test (INR) is above 2, or your hemoglobin (the oxygen-carrying part of blood) is below 7.
  • You have or have had an overactive thyroid, even without symptoms, or plan to have radioactive iodine scans or treatment.
  • You are allergic to Lipiodol or mitomycin, have an iodine contrast dye allergy that cannot be managed with medicines, or have another condition the study doctor thinks could affect your safety or the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (2)

CA

NY