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Monoclonal Antibodies
Atezolizumab + Pirfenidone for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Chao Huang, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is able to swallow oral medications
Eastern Cooperative Group (ECOG) Performance Status 0 - 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 up to 1 year post-cycle 1 day 1 (each cycle is 21 days)
Awards & highlights
Study Summary
This trial is testing whether adding pirfenidone to atezolizumab will make the latter more effective in treating stage 4 and recurrent non- small cell lung cancer.
Who is the study for?
Adults with stage 4 or recurrent non-small cell lung cancer (NSCLC) who've had certain prior treatments can join. They must be able to take oral meds, have good organ function and a life expectancy of at least 6 months. Smokers over one pack/day, those with recent serious illnesses, uncontrolled HIV, or active pneumonitis are excluded.Check my eligibility
What is being tested?
The trial is testing if combining pirfenidone with atezolizumab improves treatment outcomes for NSCLC patients who've seen their cancer return after initial therapy. It aims to see if this combo can boost anti-tumor effects and overcome resistance to treatment.See study design
What are the potential side effects?
Atezolizumab may cause immune-related inflammation in organs, infusion reactions, fatigue, and increase infection risk. Pirfenidone could lead to liver issues, stomach discomforts like nausea or vomiting, skin reactions from sunlight exposure, and tiredness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
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I am able to care for myself and perform daily activities.
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I am 18 or older with confirmed non-small cell lung cancer.
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My cancer's PDL1 score is below 1% or not known, and I need a specific first-line treatment.
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My stage III NSCLC came back and can't be removed by surgery. I've had chemoradiation and PD1/PDL1 inhibitor treatment.
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My early stage lung cancer was treated with chemo and then PD1/PDL1 inhibitors for recurrence.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 1 up to 1 year post-cycle 1 day 1 (each cycle is 21 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 up to 1 year post-cycle 1 day 1 (each cycle is 21 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of Grade 3 toxicity
Occurrence of Grade 4 toxicity
Secondary outcome measures
1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1
Overall response rate (ORR) of participants
Progression Free Survival (PFS)
Side 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%
Pain in extremity
7%
Peripheral sensory neuropathy
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: TreatmentExperimental Treatment1 Intervention
Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks.
Pirfenidone (Esbriet) orally (PO) with food according to this schedule:
Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID
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?
University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,182 Total Patients Enrolled
parkview cancer instituteUNKNOWN
Chao Huang, MDPrincipal InvestigatorThe University of Kansas
3 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had severe side effects from previous immunotherapy.You smoke more than 20 cigarettes a day.My HIV is not under control.I haven't taken any monoclonal antibody treatments in the last 4 weeks, except for denosumab.I have been treated for another cancer within the last year.My diabetes is not under control.I am allergic to atezolizumab or pirfenidone.I can take pills by mouth.I am able to care for myself and perform daily activities.I am 18 or older with confirmed non-small cell lung cancer.I have a serious heart condition, such as recent heart attack or severe heart failure.My cancer's PDL1 score is below 1% or not known, and I need a specific first-line treatment.I have brain metastasis or leptomeningeal disease that is not under control and requires steroids.My stage III NSCLC came back and can't be removed by surgery. I've had chemoradiation and PD1/PDL1 inhibitor treatment.I have lung inflammation caused by a medication.My advanced lung cancer lacks specific mutations and has been treated with limited therapies.You have an ongoing autoimmune disease.You have at least one spot that can be measured to see if the treatment is working.My organs are working well.I am currently taking medication for a bacterial or fungal infection.I do not have any health or mental conditions that would affect my participation.My blood counts are within a healthy range.You are expected to live for at least 6 more months.I am not taking any strong CYP1A2 inhibitors.My early stage lung cancer was treated with chemo and then PD1/PDL1 inhibitors for recurrence.I have been diagnosed with an active peptic ulcer in the last 4 weeks.I was diagnosed with a lung injury from radiation in the last 3 months.I have had lung inflammation treated with steroids or other medicines.I am currently being treated for an infection.I have had cancer other than lung cancer but haven't been treated for it in the last year.I still have side effects from treatment over 4 weeks ago that affect my daily activities.You have signs of active lung inflammation on a chest CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Are there any current vacancies in this clinical trial for new participants?
"Unfortunately, this clinical trial is not actively recruiting patients right now. The study was first posted on December 1st, 2022 and was last updated on January 20th, 2022. There are currently 1404 other trials looking for stage iv NSCLC patients and 370 trials searching for Atezolizumab candidates."
Answered by AI
How many volunteers are needed for this clinical trial to be effective?
"This clinical trial is not currently enrolling patients. The original posting was on December 1st, 2022, with the most recent update occurring on January 20th, 2022. There are presently 1404 other stage iv nsclc trials and 370 Atezolizumab trials that are actively seeking participants."
Answered by AI
Have other similar trials been conducted in the past?
"The first study investigating Atezolizumab was conducted in 2008 by Hoffmann-La Roche. After the successful Phase 1 trial with 720 participants, Atezolizumab received drug approval and 370 clinical studies are still ongoing today across 74 countries and 1669 cities."
Answered by AI
What are the common conditions that Atezolizumab is used to treat?
"Atezolizumab is primarily used to target small cell lung cancer; however, it also has potential applications in treating mild idiopathic pulmonary fibrosis, malignant neoplasms, and non-small cell lung carcinoma."
Answered by AI
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