Atezolizumab for Pulmonary Fibrosis

Overseen By Vivian Hwe

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Anticoagulants, Bronchodilators, Immunosuppressives, others

Disqualifiers: Asthma, Tuberculosis, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and initial effectiveness of atezolizumab, a drug typically used for cancer, in treating idiopathic pulmonary fibrosis (IPF). IPF is a lung disease that causes scarring and makes breathing difficult. Participants diagnosed with IPF who have had a specific type of lung scan in the past six months might be a good fit. The trial aims to determine if atezolizumab can help manage or improve IPF symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like cytotoxic or immunosuppressive drugs, cytokine modulating therapies, and some bronchodilators must not be used close to the screening period. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that atezolizumab is generally safe for treating certain cancers. This medicine helps the immune system fight cancer cells. However, in patients with non-small cell lung cancer (NSCLC) who also had interstitial lung disease (ILD), about 23.5% experienced severe lung inflammation, known as pneumonitis.

This study focuses on idiopathic pulmonary fibrosis (IPF), a different condition. While the drug is approved for other uses, its safety for IPF patients remains under investigation. The trial aims to determine how well patients with IPF can tolerate the drug. As this is an early stage of testing, the researchers are still learning about its safety for IPF. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pulmonary fibrosis, which typically include medications like corticosteroids or antifibrotic drugs such as pirfenidone and nintedanib, atezolizumab offers a novel approach by targeting the immune system. Atezolizumab is a monoclonal antibody that blocks the PD-L1 protein, which can help the immune system recognize and attack disease-related cells more effectively. This unique mechanism of action has researchers excited because it represents a shift away from simply managing symptoms towards potentially altering the disease process itself. Additionally, atezolizumab is administered intravenously every three weeks, which might offer a more convenient dosing schedule compared to daily oral medications.

What evidence suggests that atezolizumab might be an effective treatment for idiopathic pulmonary fibrosis?

Research shows that atezolizumab, a medicine that aids the immune system in fighting diseases, is being studied in this trial for its potential to treat idiopathic pulmonary fibrosis (IPF). Although primarily used for cancer treatment, early results in similar lung conditions are encouraging. For instance, a study with 17 patients who had both non-small cell lung cancer and interstitial pneumonia found that 53.3% survived for at least a year after receiving atezolizumab, suggesting potential benefits. Additionally, it appears to have a lower risk of causing severe lung inflammation compared to other treatments for similar conditions. While specific data for IPF is still being gathered, these findings offer hope for its possible effectiveness. ^{1 2 4 6 7}

Who Is on the Research Team?

Tanzira Zaman, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You tested negative for hepatitis B surface antigen.

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

You must have a specific pattern in your high-resolution CT scan of the lungs that shows a condition called UIP.

Exclusion Criteria

I am currently on medication for hepatitis B.

I had TB but completed treatment successfully.

I have had a blood clot in my leg or lung in the past 6 months or have had them more than once.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab 1200 mg IV every 3 weeks for 24 weeks

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Atezolizumab Experimental Treatment 1 Intervention

Atezolizumab 1200 mg IV every 3 weeks for 24 weeks

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

Atezolizumab, an immune checkpoint inhibitor, is being tested in a phase II trial for its safety and efficacy in patients with advanced non-small cell lung cancer (NSCLC) who also have chronic fibrotic interstitial pneumonia, with a focus on a 1-year survival rate among 38 participants.

This study is significant as it aims to establish a treatment option for a patient group that currently lacks standard second-line therapies, potentially improving outcomes for those with both NSCLC and interstitial pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of atezolizumab for pretreated advanced/recurrent non-small cell lung cancer with idiopathic interstitial pneumonias: rationale and design for the TORG1936/AMBITIOUS study. Ikeda, S., Kato, T., Kenmotsu, H., et al.[2022]

Atezolizumab is the first approved anti-PD-L1 inhibitor for treating squamous cell lung cancer (SqCLC) in patients who have experienced disease progression after initial therapies, highlighting its role in advanced stages of non-small cell lung cancer (NSCLC).

Current research is exploring atezolizumab's effectiveness in various treatment settings for SqCLC, indicating its potential for broader applications in future clinical scenarios, although specific target agents for this cancer subtype remain limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti PD-L1 antibody: is there a histologic-oriented efficacy? Focus on atezolizumab in squamous cell non-small cell lung cancer. Gemelli, M., Bidoli, P., Colonese, F., et al.[2022]

Atezolizumab (Tecentriq) is an FDA-approved treatment for unresectable or metastatic alveolar soft part sarcoma (ASPS), showing a 24% overall response rate in a clinical trial with 49 patients, and a durable response rate of 67% at 6 months and 42% at 12 months.

The treatment has a manageable safety profile, with common severe side effects including musculoskeletal pain (8%) and hypertension (6%), making it a viable option for patients with limited treatment alternatives for this high-risk disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. Bergsma, EJ., Elgawly, M., Mancuso, D., et al.[2023]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab, an anti-PD-L1 antibody used for treating non-small cell lung cancer, can lead to severe immune-related adverse events (irAEs), including life-threatening conditions like pneumonitis, thrombocytopenia, and cardiac dysfunction.

In this case, while pneumonitis resolved with treatment, the other severe irAEs did not improve, ultimately leading to the patient's death, highlighting the critical need for effective management strategies for irAEs in cancer immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatal outcome of atezolizumab in a patient with immune-mediated pneumonitis, thrombocytopenia, and cardiac dysfunction: A case report . Li, J., Deng, X., Wang, B., et al.[2020]

Atezolizumab monotherapy was associated with a high incidence of pneumonitis in patients with advanced or recurrent NSCLC and comorbid idiopathic interstitial pneumonia, leading to the early termination of the study.

Out of 17 enrolled patients, 29.4% experienced pneumonitis, with a notably higher risk (57.1%) in those with honeycomb lung, indicating that this patient population may be particularly vulnerable to immune checkpoint inhibitor-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2 Study of Atezolizumab for Pretreated NSCLC With Idiopathic Interstitial Pneumonitis. Ikeda, S., Kato, T., Kenmotsu, H., et al.[2023]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

In a study of 17 patients with non-small cell lung cancer and interstitial pneumonia, atezolizumab showed a 1-year survival rate of 53.3%, indicating potential efficacy despite the high risk of severe side effects.

The incidence of pneumonitis was notably high at 29.4%, with 23.5% of cases being severe (grade ≥3), highlighting a significant safety concern for this treatment in patients with comorbid interstitial pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for Pretreated Non-Small Cell Lung Cancer with Idiopathic Interstitial Pneumonia: Final Analysis of Phase II AMBITIOUS Study. Ikeda, S., Kato, T., Kenmotsu, H., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05515627

Atezolizumab for Idiopathic Pulmonary Fibrosis The secondary objectives of the study are to determine change in forced vital capacity, qualitative radiographic change in extent of fibrosis, and patient- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170387/

Atezolizumab and nintedanib in patients with non-small ... A single-arm phase II trial of atezolizumab in patients with NSCLC with pre-existing ILD showed that 23.5% developed severe pneumonitis of grade ...

3. withpower.com withpower.com/trial/phase-1-fibrosis-8-2022-6d0f9

Atezolizumab for Pulmonary Fibrosis In a study of 17 patients with non-small cell lung cancer and interstitial pneumonia, atezolizumab showed a 1-year survival rate of 53.3%, indicating potential ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S155608642030678X

A Phase 2 Study of Atezolizumab for Pretreated NSCLC ... Atezolizumab monotherapy is an established treatment for recurrent NSCLC and reported to have a lower risk of pneumonitis than programmed cell death protein 1 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9438913/

Atezolizumab for Pretreated Non-Small Cell Lung Cancer with ... This study included patients with idiopathic chronic fibrotic IP, with a predicted forced vital capacity (%FVC) of >70%, with or without ...

6. lungcancerjournal.info lungcancerjournal.info/article/S0169-5002(24)00377-5/fulltext

Safety and Patient-Reported outcomes of atezolizumab plus ... In PPA, we observed a significant improvement in GHS score with a significant improvement in fatigue, dyspnea and cough. At week 54, we observed ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/356776

Atezolizumab for Idiopathic Pulmonary Fibrosis The purpose of this study is to determine the safety and preliminary efficacy of atezolizumab, an immune checkpoint inhibitor approved for ...