#1 Clinical Trials Search in Europe

Lung disorder – Trials in Disease

Go back

Ongoing Clinical Trials for Lung Disorder

This article provides information about 4 ongoing clinical trials for lung disorder and related conditions. The trials are investigating treatments for Alpha-1 Antitrypsin Deficiency-related lung disease, COVID-19 with respiratory complications, and EGFR mutant non-small cell lung cancer. These studies are being conducted across multiple countries in Europe, offering opportunities for eligible patients to access experimental therapies.

Clinical trial locations

Study on the Safety and Effectiveness of BEAM-302 with MR0005 and GR0015 for Adults with Alpha-1 Antitrypsin Deficiency-Related Lung or Liver Disease

This trial is investigating BEAM-302, a gene therapy treatment, for adults with Alpha-1 Antitrypsin Deficiency that affects the lungs or liver. The study is conducted in two phases: the first explores different doses to find the safest and most effective amount, while the second confirms the optimal dose and assesses how well the treatment works.

Who can participate:

  • Adults between 18 and 70 years old with confirmed Alpha-1 Antitrypsin Deficiency and the PiZ gene mutation
  • Patients with evidence of liver fibrosis (stages F1, F2, or F3) or emphysema on CT scan
  • Individuals with a lung function test showing FEV1 of 40% or more of predicted value
  • Those willing to avoid alcohol, certain medications, and strenuous exercise during the study period
  • Patients willing to participate in a long-term follow-up study lasting up to 15 years

Who cannot participate:

  • People with other serious health conditions that could interfere with the study
  • Pregnant or breastfeeding women
  • Those who participated in another clinical trial within the last 30 days
  • Individuals with a history of allergic reactions to similar treatments
  • People with recent drug or alcohol abuse, organ transplants, or active infections requiring treatment
  • Those with a history of cancer within the last 5 years (with certain exceptions)

What the trial involves: BEAM-302 is administered as a single intravenous infusion. The study aims to evaluate how this gene therapy affects protein levels in the blood related to Alpha-1 Antitrypsin and whether it can improve lung and liver function. Participants will be closely monitored for side effects and changes in their condition throughout the study period.

Investigational drug: BEAM-302 is an experimental gene therapy designed to address the underlying genetic cause of Alpha-1 Antitrypsin Deficiency by potentially increasing the production of the missing protein that protects the lungs and liver from damage.

Study on Baricitinib for Hospitalized Patients with Severe or Critical COVID-19

This trial examines whether baricitinib, when added to standard care, can help reduce the risk of death in hospitalized patients with severe or critical COVID-19 who have weakened immune systems. The study compares baricitinib to a placebo to determine if the medication provides additional benefits.

Who can participate:

  • Adults 18 years or older with laboratory-confirmed COVID-19 infection within the last 14 days
  • Hospitalized patients with severe or critical disease (low oxygen levels, breathing difficulties, or requiring oxygen support or mechanical ventilation)
  • Immunocompromised individuals due to conditions such as certain blood cancers, organ transplants, HIV with low CD4 counts, primary immunodeficiency, or autoimmune disorders treated with immunosuppressive medication
  • Those with elevated inflammatory markers (ferritin, LDH, or CRP above specific levels)

Who cannot participate:

  • Patients without confirmed SARS-CoV-2 infection
  • Those not hospitalized with moderate, severe, or critical COVID-19
  • People who are not immunocompromised
  • Individuals outside the specified age range or not meeting other health criteria

What the trial involves: Participants receive either baricitinib or a placebo in the form of a 2 mg tablet taken once daily. The study monitors patients’ health closely, including inflammatory markers and oxygen levels, to assess whether the medication helps prevent disease progression and improves survival rates.

Investigational drug: Baricitinib is an anti-inflammatory medication that works by reducing the body’s inflammatory response, which can be severe in COVID-19 cases. It belongs to a class of drugs called Janus kinase inhibitors.

Study on the Effectiveness and Safety of Bemcentinib for Hospitalized Patients with Moderate COVID-19

This study evaluates bemcentinib, a receptor tyrosine kinase inhibitor, in hospitalized patients with moderate COVID-19. The trial compares bemcentinib combined with standard care to a placebo with standard care to determine if the medication improves patient outcomes.

Who can participate:

  • Adults over 18 years of age with confirmed SARS-CoV-2 infection (PCR or antigen test no more than 10 days old)
  • Hospitalized patients with moderate disease who either don’t need oxygen therapy or require oxygen by mask or nasal prongs
  • Those with lower respiratory symptoms and either needing supplemental oxygen or showing new lung changes on X-ray consistent with COVID-19 pneumonia
  • Patients able to provide informed consent

Who cannot participate:

  • Patients not hospitalized with moderate COVID-19
  • Those outside the specified age range
  • Members of vulnerable populations

What the trial involves: Participants take bemcentinib capsules or a placebo orally, alongside standard hospital care. The study monitors disease progression using an 11-point scale, oxygen levels, recovery time, and any adverse events. Follow-up assessments continue for 90 days to evaluate recovery and quality of life.

Investigational drug: Bemcentinib works by blocking a specific protein called AXL that may play a role in how the virus affects cells, potentially reducing disease severity and improving recovery in hospitalized patients.

Study on the Effectiveness of Osimertinib for Patients with EGFR Mutant Non-Small Cell Lung Cancer Based on TP53 Mutation Status

This trial investigates osimertinib in patients with non-small cell lung cancer that has EGFR gene mutations. The study specifically examines how the presence of TP53 gene mutations affects treatment effectiveness in patients who have not received previous treatment for advanced disease.

Who can participate:

  • Adults over 18 years old with locally advanced or metastatic EGFR mutant non-small cell lung cancer (with specific EGFR exon 19 deletion or exon 21 p.L858R mutation)
  • Patients whose cancer cannot be treated with surgery or radiotherapy
  • Those who have not received treatment for advanced disease and are eligible for first-line osimertinib treatment
  • Individuals with a WHO performance status of 0-1 (fully active or with some symptoms but not requiring bed rest)
  • Patients with at least 12 weeks life expectancy and at least one measurable tumor lesion
  • Those able to provide tumor tissue samples for analysis

Who cannot participate:

  • Patients without EGFR gene mutations
  • Those with specific TP53 gene mutations (as the study is comparing outcomes based on TP53 status)
  • Individuals outside the specified age range
  • Members of vulnerable populations

What the trial involves: Participants take osimertinib as an 80 mg tablet once daily at the same time each day. The study monitors how long patients can live without cancer progression, with regular clinic visits and imaging tests like CT or MRI scans to measure tumor size and response to treatment.

Investigational drug: Osimertinib is a targeted therapy called a tyrosine kinase inhibitor that blocks the activity of mutated EGFR proteins in cancer cells, helping to slow or stop cancer growth and spread.

Summary

These four clinical trials represent diverse approaches to treating different types of lung-related conditions. Two trials focus on COVID-19 treatment in hospitalized patients at different disease stages, using medications that work by reducing inflammation or blocking viral mechanisms. One trial explores a novel gene therapy for Alpha-1 Antitrypsin Deficiency, a genetic condition affecting both lungs and liver. The fourth trial investigates targeted therapy for a specific type of lung cancer with known genetic mutations.

Geographically, the COVID-19 trials show the broadest distribution, with baricitinib being studied across 14 European countries and bemcentinib across 10 countries. This wide geographic spread reflects the global nature of the pandemic and the urgent need for effective treatments. In contrast, the Alpha-1 Antitrypsin Deficiency trial is limited to the Netherlands and Ireland, while the lung cancer trial is conducted only in Italy.

The trials demonstrate different stages of drug development, from exploring novel gene therapies to evaluating targeted cancer treatments based on specific genetic markers. Each study requires long-term commitment from participants, with follow-up periods ranging from 90 days to 15 years, reflecting the nature of the conditions being studied and the need for comprehensive safety and effectiveness data.

Ongoing Clinical Trials on Lung disorder

More information about
Lung disorder:

Connected medications: