Atezolizumab for Idiopathic Pulmonary Fibrosis

NCT05515627 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00001474
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and preliminary efficacy of atezolizumab, an immune checkpoint inhibitor approved for the treatment of various cancers, in patients with idiopathic pulmonary fibrosis (IPF).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

pulmonary fibrosis; ipf; idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Number of participants with treatment-related adverse events as defined by NCI CTCAE v4.03

  24 weeks

Secondary Outcomes (5)

• Forced vital capacity

  24 weeks

• Radiologic extent of fibrosis

  24 weeks

• Six minute walk distance

  24 weeks

• St. George's Respiratory Questionnaire

  24 weeks

• University of California San Diego (UCSD) Shortness of Breath Questionnaire

  24 weeks

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Atezolizumab 1200 mg IV every 3 weeks for 24 weeks

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Atezolizumab 1200 mg administered via intravenous infusion every 3 weeks

Atezolizumab

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥50 years of age
• Confident diagnosis of IPF per 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF1
• Subjects must have a high-resolution computed tomography (HRCT) completed in the 6 months prior to informed consent
• Subjects must have HRCT pattern of definite or probable UIP
• Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy showing histopathology consistent with UIP
• Extent of fibrotic changes must be greater than the extent of emphysema on HRCT
• Review of all available IPF treatment options with the potential subject prior to consent for participation in the study
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAB test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
• Negative hepatitis C antibody
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
• Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.
• A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
• Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

You may not qualify if:

• FVC \<50% of predicted, DLCO \< 30% of predicted, FEV1/FVC ratio \<0.7
• Significant clinical worsening of IPF between screening and baseline visits as defined by \> 10% decline in FVC or new requirement for supplemental oxygen
• Evidence of secondary etiologies of ILD (signs/symptoms of connective tissue disease, including ANA titer \> 1:80, history of exposures related to hypersensitivity pneumonitis, history of drug-related pulmonary toxicity, occupational exposures)
• Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
• Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or dosing
• Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
• Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
• Any condition that in the opinion of the investigators would confound the ability to interpret data from the study
• QTc \> 470 msec
• Any comorbid condition that is likely to result in death within the next year
• Inability to obtain reproducible, high-quality pulmonary function tests
• Likelihood of lung transplantation in the first 24 weeks of the study
• Use of other IPF-directed therapies beside SOC including but not limited to endothelium receptor antagonists, interferon gamma-1b, N-acetylcysteine
• Initiation of pirfenidone or nintedanib less than 90 days prior to screening
• Current therapy or treatment within 60 days prior to screening of any cytotoxic or immunosuppressive medications, cytokine modulating therapies, and oral anticoagulants within 4 weeks of the screening visit. Note: oral anticoagulants taken for alternative diagnoses are acceptable and should not be discontinued for the sole purpose of study participation.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanzira Zaman, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 25, 2022
• Study Start: February 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)