Lung Clinical Trials

With multiple research labs at Cedars-Sinai, our leading lung specialists and research scientists work together to pioneer new imaging technologies, therapies and minimally invasive surgical techniques. As a patient with us, you'll have the potential to participate in groundbreaking pulmonary clinical trials.

Questions? See the Clinical Trial FAQs.


Click below to view clinical trials by areas:

Alpha-1 Antitrypsin Deficiency

Condition:

A1PI deficiency

Key Inclusion Criteria

  • For subjects who will undergo bronchoscopy/BAL procedures: 18 to 75 years old at time of screening
  • For subjects who will be waived from undergoing bronchoscopy/BAL procedures: At least 18 years old at the time of screening
  • Must have at least one of the following: clinical diagnosis of emphysema, evidence of emphysema and/or evidence of airway obstruction which is not completely reversed with bronchodilator treatment at the time of screening

Summary:

This study focuses on patients who have an inherited disorder called severe alpha1- proteinase inhibitor (A1PI) deficiency, also known as alpha1-antitrypsin (AAT) deficiency. A1PI is a protein that is normally present in the body to help protect the lungs. A1PI deficiency may lead to damage to lung tissue, which worsens over time and may develop into chronic obstructive pulmonary disease (COPD). The purpose of the study is to evaluate the investigational use of a drug called GLASSIA and to determine whether there are any differences in symptoms and side effects when patients receive this drug with a higher particle count or lower particle count (number of protein clusters). Researchers also aim to learn how the immune system may react to  the drug and whether GLASSIA can increase the level of A1PI in the lungs.

Interstitial Lung Disease

Condition:

Idiopathic pulmonary fibrosis

Key Inclusion Criteria

  • ≥40 years old
  • Diagnosed with IPF within four years of screening
  • Diagnosis of IPF is supported by high resolution computed tomography and historical surgical lung biopsy

Summary:

The purpose of this study is to determine the effects of an investigational drug called CC-90001 on patients diagnosed with idiopathic pulmonary fibrosis (IPF), a condition in which scarring of the lungs occurs. Participants will be randomly assigned to receive CC-90001 or placebo (inactive substance). Researchers will assess the effect of CC-90001 on improving IPF, in addition to how well the body tolerates the drug. Another purpose of the study is to determine whether a biomarker test can show how IPF is affected by CC-90001 in a specific group of cells in the body. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease.

Condition:

Progressive fibrosing interstitial lung disease

Key Inclusion Criteria

  • At least 18 years old
  • Patients with physician-diagnosed interstitial lung disease (ILD) who fulfill at least one specific criteria for PF-ILD within 24 months of screening visit, despite treatment with unapproved medications used in clinical practice to treat ILD
  • Fibrosing lung disease on high resolution computed tomography

Summary:

This study focuses on patients with progressive fibrosing interstitial lung disease (PF-ILD). The purpose of the study is to evaluate the investigational use of a drug called nintedanib. Researchers aim to determine how well nintedanib may help participants’ lung disease and will compare the safety and effects of nintedanib with placebo (inactive substance). The study involves two parts. The first part will evaluate the effectiveness and safety of nintedanib, and the second part will collect longer-term effectiveness and safety data of the drug.

Condition:

Idiopathic pulmonary fibrosis

Key Inclusion Criteria

  • At least 40 years old
  • Women must be surgically sterile, postmenopausal or agree to use contraception; male subjects must agree to use one or more forms of birth control.
  • Diagnosis of IPF

Summary:

The purpose of this study is to evaluate the investigational use of a drug called BG00011 in patients with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. The study aims to determine the safety and effectiveness of the drug compared to placebo (inactive substance) in these patients. BG00011 is a laboratory-made antibody that is being developed to treat IPF. An antibody is a type of protein that is made by the body to help protect it from harmful substances. Participants will be randomly assigned to receive either BG00011 or placebo. Researchers also aim to learn whether a biomarker test will help determine the effects of BG00011 on the patient’s IPF. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease.

Pulmonary Embolism

Condition:

Pulmonary embolism

Key Inclusion Criteria

  • 18-75 years old
  • Clinical signs, symptoms and presentation consistent with acute pulmonary embolism
  • Pulmonary embolism symptom duration less than or equal to 14 days
  • Computed tomography angiography evidence of proximal pulmonary embolism

Summary:

This study focuses on individuals diagnosed with a pulmonary embolism (blood clot) that is trapped within the lungs. The purpose of the study is to evaluate the safety and effectiveness of the FlowTriever Aspiration System (referred to as “FlowTriever System”) for removing blood clots from pulmonary arteries (vessels that transport blood from the heart to the lungs). The FlowTriever System is a medical device that is used to trap the clot and pull it into a thin tube (catheter) so that the clot can be removed from the body. The device has been approved by the U.S. Food and Drug Administration for removing emboli and thrombi (blood clots) from blood vessels, but its use in this study is investigational.

Condition:

Pulmonary embolism

Key Inclusion Criteria

  • 18-75 years old with body weight between 50-130 kg (110-286 lbs)
  • Admitted to the hospital with a clinical diagnosis of acute PE with an onset of symptoms in the five days prior to diagnosis categorized as low-risk, intermediate-risk or submassive PE and for whom catheter-based therapy is not planned

Summary:

This study focuses on individuals who have a blood clot in their lung(s) called a pulmonary embolism (PE). Normal standard of care for a blood clot is treatment with heparin followed by a blood thinner. The purpose of the study is to evaluate the safety of increasing doses of an investigational drug called DS-1040b when administered with standard-of-care treatment and to assess whether adding this drug to standard of care may help in the treatment of blood clots. Researchers aim to determine the best way to give DS-1040b and which dose of the drug is safe to use. Participants will be randomly assigned to receive either DS-1040b or placebo (inactive substance).

Pulmonary Vascular Disease

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • Patient must be a permanent resident of the United States.
  • Radiologic confirmation that chronic thromboembolic disease is the cause of the pulmonary hypertension
  • Patients must be diagnosed with CTEPH within six months of being considered for study eligibility.

Summary:

This purpose of this research registry is to collect clinical information about patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH). Researchers aim to learn more about the CTEPH disease process and treatment of patients by sharing information among pulmonary hypertension centers throughout the U.S.

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • Adults at least 18 years old and less than or equal to 75 years of age
  • Body mass index greater than 18.5 kg/m2
  • Symptomatic pulmonary arterial hypertension
  • Diagnostic right heart catheterization documented within 36 months that confirmed a diagnosis of PAH

Summary:

This study is designed to test the investigational use of a drug called bardoxolone methyl in patients with pulmonary arterial hypertension (PAH). Researchers will test the safety and effectiveness of bardoxolone methyl by evaluating how the drug influences exercise ability and PAH disease symptoms. In addition, the study will examine the effect of bardoxolone methyl on the function of the heart and blood vessels in the lungs.

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • At least 18 years old
  • Surgical implantation of LVAD
  • Evidence of pulmonary hypertension on baseline right heart catheterization

Summary:

The purpose of this study is to evaluate the safety and effects of an investigational drug called macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Pulmonary hypertension is a disorder of the blood vessels of the lungs, which can occur or worsen after implantation of an LVAD. Researchers will assess the effects of macitentan on the properties and function of the heart, as well as on blood pressure in the pulmonary arteries.

Condition:

Pulmonary hypertension

Key Inclusion Criteria

  • Patients newly treated with Opsumit defined as a new user of therapy, initiated less than or equal to 30 days prior to enrollment visit or at enrollment
  • Signed informed consent

Summary:

This observational study focuses on patients who are initiating therapy with a drug called Opsumit for the treatment of pulmonary arterial hypertension or another etiology (cause of disease). The purpose of the OPUS registry is to better understand the use of Opsumit in the clinical practice, including further characterization of the safety profile for the drug. Other goals include describing the demographic and clinical characteristics of patients treated with Opsumit. Opsumit is approved by the U.S. Food and Drug Administration for the treatment of pulmonary arterial hypertension.