Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will test the safety and preliminary effectiveness of a new cancer drug in patients with IPF, a lung condition.
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.Check my eligibility
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.See study design
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 belowSelect...
My lung biopsy shows UIP but my HRCT does not definitely confirm it.
Select...
I agree to not have sex or will use a condom, and I won't donate sperm.
Select...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Forced vital capacity
Radiologic extent of fibrosis
Six minute walk distance
+2 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,875 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,905 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
2,826 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Tanzira Zaman, MDPrincipal InvestigatorCedars-Sinai Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for hepatitis B.You tested negative for hepatitis B surface antigen.My lung biopsy shows UIP but my HRCT does not definitely confirm it.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.I haven't taken any strong immune or blood thinning medications in the last 60 days.I haven't had major heart issues or strokes in the last 3 months.You must have a specific pattern in your high-resolution CT scan of the lungs that shows a condition called UIP.I have not had a fever or been sick in the last 14 days.I have an autoimmune disease, but it's not vitiligo or diabetes.You have been diagnosed with IPF according to specific medical guidelines from 2018.You have had a transplant using cells or organs from another person.I have a lung condition like asthma or tuberculosis.Your heart takes too long to recharge between beats.I have used a long-acting inhaler within the last day or a short-acting one within the last 8 hours.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.My calcium levels are not higher than normal and I don't have symptoms of high calcium.I have had cancer spread to the lining of my brain and spinal cord.You need to have had a high-resolution CT scan in the 6 months before agreeing to take part in the study.I am at high risk for side effects from cancer immunotherapy due to my existing conditions.I have tested negative for hepatitis B or, if positive, my viral load is undetectable.I have not received a live vaccine within the last 4 weeks and do not plan to during or within 5 months after treatment.I started taking pirfenidone or nintedanib less than 3 months ago.I have previously been treated with specific immune therapies.I do not need frequent procedures to remove excess fluid from my body.You have had serious allergic reactions to certain types of medications made from proteins.You are unable to do breathing tests that give consistent and accurate results.I have discussed all treatment options for my lung condition before agreeing to join the study.The amount of scarring in your lungs must be more than the amount of damage from emphysema on a specific type of lung scan.I have signs of lung disease not caused by my primary condition, including a positive ANA test or exposure to harmful substances.I do not have any health conditions expected to cause death within a year.I haven't had serious infections or been hospitalized for infections in the last 4 weeks.I might get a lung transplant within the next 6 months.You do not have hepatitis C.I agree to not have sex or will use a condom, and I won't donate sperm.Your lung function tests show that your lungs are not working well.You need to have a negative pregnancy test within 14 days before starting the study treatment.I had cancer before, but it was a type with a high survival rate or was caught early and treated.You are allergic to components of the atezolizumab medication, which includes a type of cell called Chinese hamster ovary cells.I don't have any health issues that would make it unsafe for me to take a new drug.I am 50 years old or older.My lung function has significantly worsened recently.I am not using any specific treatments for IPF other than standard care.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Atezolizumab been sanctioned by the Food and Drug Administration?
"The safety rating of Atezolizumab was found to be 1, as it is a Phase 1 trial with limited evidence for efficacy and safety."
Answered by AI
What criteria is necessary to qualify for this experiment?
"24 individuals need to be recruited for this clinical trial and they must possess usual interstitial pneumonia, being between 50 and 80 years of age."
Answered by AI
Are volunteers currently being enrolled in this investigation?
"Per clinicaltrials.gov, this particular medical study is not taking on any new patients at the moment - it was initially posted September 1st 2022 and last updated August 24th 2022. However, there are 411 other studies that are actively recruiting participants right now."
Answered by AI
Does this experiment allow participants beyond the age of sixty?
"In compliance with the requirements for this research trial, participants must fall between ages 50 and 80."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
California
Minnesota
What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger