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.

Condition:

Idiopathic pulmonary fibrosis

Key Inclusion Criteria

  • Between 40 and 80 years old
  • Women of childbearing potential and all male participants must agree to use contraception
  • Features consistent with idiopathic pulmonary fibrosis (IPF) within 5 years prior to screening

Summary:

The purpose of this study is to evaluate the safety and tolerability of an experimental drug called TRK-250 after single and multiple inhaled doses in patients with idiopathic pulmonary fibrosis (IPF). TRK-250 is intended to inhibit the messages in the cell that create a protein involved in lung fibrosis (scarring). This study will be conducted in two parts, single inhaled dose (Part A) and multiple inhaled doses (Part B). Subjects in both parts will be randomly assigned to receive either TRK-250 or placebo (inactive substance). 

Condition:

Idiopathic pulmonary fibrosis

Key Inclusion Criteria

  • Between 40 and 80 years old
  • Diagnosis of idiopathic pulmonary fibrosis (IPF) within 5 years

Summary:

This study focuses on individuals who have idiopathic pulmonary fibrosis (IPF) and are between 40 and 80 years old. The purpose of the study is to evaluate the safety of an experimental medication called ND‑L02‑s0201 when administered at two dose levels compared with placebo (inactive substance).

ND-L02-s0201 is made up of tiny particles of fat that also contain a small amount of RNA (ribonucleic acid) that is the active drug. The RNA in ND-L02-s0201 is designed to block the lungs from making a protein called "heat shock protein 47" (HSP47) for a limited period of time. It is thought that blocking the lungs from making HSP47 will help treat IPF because one of the roles of HSP47 is to help make collagen, which is involved in fibrosis (scarring).

Participation in the study will be approximately 40 weeks, including a screening and baseline period of up to 6 weeks, a treatment period of 24 weeks and a follow-up period of 10 weeks. Participants will attend 16-17 on-site visits at Cedars-Sinai and will receive an IV study drug infusion every 2 weeks at Cedars-Sinai during the treatment period.

Condition:

Idiopathic pulmonary fibrosis

Key Inclusion Criteria

  • Currently taking nitendanib for 3-18 months
  • At least 40 years old at time of screening 

Summary:

The purpose of this study is to examine pulmonary rehabilitation in individuals with idiopathic pulmonary fibrosis (IPF) who are taking a medication called Ofev (nintedanib). The study aims to determine whether pulmonary rehabilitation improves the physical activities and quality of life in these patients. Pulmonary rehabilitation (PR) is a program that may include exercise, education and support to help improve the health of individuals with breathing diseases.

Specifically, the study will determine the difference in change from baseline assessment when PR is added to stable underlying Ofev therapy in patients with IPF; evaluate the difference in quality of life when PR is added to stable underlying Ofev therapy; and determine whether PR has an enduring effect when added to stable underlying Ofev therapy.

Participants will be randomly assigned to one of two study groups. The first group will receive pulmonary rehabilitation several times a week for 12 weeks at the Cedars-Sinai Pulmonary Rehabilitation Program; the second group will not receive pulmonary rehabilitation. All participants will continue to take Ofev as prescribed. 

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).

Condition:

Pulmonary embolism

Key Inclusion Criteria

  • 18-75 years old
  • Chest computed tomography angiogram evidence of proximal pulmonary embolism (PE) with a filling defect in at least one main pulmonary artery or lobar artery
  • PE symptom duration ≤14 days 

Summary:

This study focuses on patients who have a blood clot in one or both of their pulmonary arteries (large blood vessels in the chest) that is interfering with blood flow through the heart and lungs. The purpose of the study is to determine how much of a pulmonary embolism (clot) can be dissolved when treated with a very low dose of a thrombolytic drug (clot buster) called alteplase (tPA) along with standard anticoagulant (blood thinning) therapy, compared to standard-of-care anticoagulant therapy alone. tPA is approved by the U.S. Food and Drug Administration (FDA) for breaking down blood clots in pulmonary embolism; however, it is not approved at the dosage the study is using.

Participants will be assigned to one of two study groups. The first group will receive the usual drug to treat pulmonary embolism (heparin) plus a placebo (inactive substance) IV infusion. The second group will receive the usual drug to treat pulmonary embolism (heparin) plus the tPA IV infusion.

Pulmonary Vascular Disease

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.

Condition:

Pulmonary arterial hypertension

Key Inclusion Criteria

  • Completed the protocol-defined end-of-study (EOS) procedures and EOS visit in the original ralinepag study
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
  • Both male and female participants agree to use a medically acceptable method of contraception

Summary:

This study focuses on individuals with pulmonary arterial hypertension (PAH) who have previously participated in another study with an investigational drug called ralinepag. PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. The purpose of the study is to evaluate the long-term effects of ralinepag on the participant's symptoms of PAH, ability to exercise, heart rate recovery (how quickly the heart rate slows down after a walking test) and quality of life. The study will also examine the long-term effects of ralinepag, when used with the patient's current treatment for PAH, on blood test results and study assessments as well as evaluate any side effects.

Condition:

Pulmonary arterial hypertension

Key Inclusion Criteria

  • 18-75 years old
  • Diagnosis of symptomatic World Health Organization Group 1 pulmonary arterial hypertension (PAH)
  • Has had a right heart catheterization performed at or within 365 days of screening that is consistent with the diagnosis of PAH

Summary:

The purpose of this study is to assess an investigational drug called ralinepag in the treatment of pulmonary arterial hypertension (PAH). PAH results from the small arteries (blood vessels) in the lungs becoming narrow or blocked. Researchers aim to determine how well ralinepag works when used with the current treatment for PAH, in addition to how it affects the ability to exercise, heart rate recovery (how quickly the heart rate slows down after a walking test) and quality of life. The study will also examine the effects of ralinepag, when used with the patient's current treatment for PAH, on blood test results and study assessments, as well as evaluate any side effects.