What is the mechanism of action of this treatment?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents like nintedanib and pirfenidone, which work by slowing the progression of fibrosis in the lungs. Nintedanib inhibits multiple tyrosine kinases involved in the signaling pathways that lead to fibrosis, while pirfenidone reduces fibroblast proliferation and the production of fibrotic mediators. These mechanisms are crucial for IPF patients as they help to preserve lung function and improve quality of life. Additionally, immune checkpoint inhibitors like atezolizumab, which block the PD-L1 pathway to enhance the immune system's ability to fight disease, are being studied for their potential to treat IPF by modulating the immune response involved in fibrosis.

What side effects are associated with this type of intervention?

Common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents like pirfenidone and nintedanib. Pirfenidone can cause side effects such as nausea, rash, and liver function abnormalities, while nintedanib may lead to diarrhea, liver enzyme elevation, and gastrointestinal issues. Immune checkpoint inhibitors like atezolizumab, which are being studied for IPF, can cause immune-related adverse events including pneumonitis, rash, and colitis. These treatments aim to manage symptoms and slow disease progression, but they come with a risk of significant side effects that require careful monitoring.

What prior FDA approvals exist?

The FDA has approved two main drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): pirfenidone and nintedanib. These drugs are antifibrotic agents that help slow disease progression. While atezolizumab, an immune checkpoint inhibitor, is being studied for its safety and efficacy in IPF, it is not yet approved for this indication. Immune checkpoint inhibitors like atezolizumab are primarily used in cancer treatment, and their role in IPF is still under investigation.

What other types of research exist?

Promising alternatives to Atezolizumab for IPF patients include: 1) Pirfenidone, which has shown benefits in unclassifiable interstitial lung disease and interstitial pneumonia with autoimmune features. 2) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown promise in clinical trials for IPF. 3) Nintedanib, approved for progressive fibrosing ILD, which may also be beneficial for IPF.

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Checkpoint Inhibitor

Atezolizumab for Pulmonary Fibrosis

Phase 1

Recruiting

Led By Tanzira Zaman, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy showing histopathology consistent with UIP

For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Must not have

Current treatment with anti-viral therapy for HBV

Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing atezolizumab, a medicine that boosts the immune system, in people aged 50 to 80 with idiopathic pulmonary fibrosis (IPF). IPF is a lung disease with no current treatments to stop its progression. Atezolizumab may help slow down lung damage by helping the immune system fight the disease.

Who is the study for?

This trial is for men and women over 50 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF), as shown by specific patterns on high-resolution CT scans or lung biopsy. Participants must not have used certain IPF treatments recently, be free from significant other diseases, and agree to contraception if applicable. They cannot join if they've had recent vaccinations, blood clots, severe allergies to similar drugs, or are smokers.

What is being tested?

The study tests the safety and initial effectiveness of Atezolizumab—an immune checkpoint inhibitor already approved for cancer treatment—in patients with IPF. It aims to see how well this drug can work in a different disease by possibly using the body's own immune system to slow down fibrosis.

What are the potential side effects?

Atezolizumab may cause side effects like inflammation in various organs including liver and intestines, hormonal imbalances, skin reactions, increased risk of infections due to weakened immunity, potential infusion-related reactions during administration of the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung biopsy shows UIP but my HRCT does not definitely confirm it.

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I agree to not have sex or will use a condom, and I won't donate sperm.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for hepatitis B.

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I haven't had major heart issues or strokes in the last 3 months.

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I have an autoimmune disease, but it's not vitiligo or diabetes.

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I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.

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My calcium levels are not higher than normal and I don't have symptoms of high calcium.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have not received a live vaccine within the last 4 weeks and do not plan to during or within 5 months after treatment.

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I have previously been treated with specific immune therapies.

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I do not have any health conditions expected to cause death within a year.

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My lung function has significantly worsened recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

Forced vital capacity

Radiologic extent of fibrosis

Six minute walk distance

+2 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AtezolizumabExperimental Treatment1 Intervention

Atezolizumab 1200 mg IV every 3 weeks for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents like nintedanib and pirfenidone, which work by slowing the progression of fibrosis in the lungs. Nintedanib inhibits multiple tyrosine kinases involved in the signaling pathways that lead to fibrosis, while pirfenidone reduces fibroblast proliferation and the production of fibrotic mediators. These mechanisms are crucial for IPF patients as they help to preserve lung function and improve quality of life. Additionally, immune checkpoint inhibitors like atezolizumab, which block the PD-L1 pathway to enhance the immune system's ability to fight disease, are being studied for their potential to treat IPF by modulating the immune response involved in fibrosis.