Actively Recruiting
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond Non-Small Cell Lung Cancer: a Phase I/II Study
Led by University of Kansas Medical Center · Updated on 2026-01-28
25
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
P
parkview cancer institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding pirfenidone to atezolizumab increases anti-tumor activity and reduces treatment resistance in people with stage 4 and recurrent non-small cell lung cancer. This study is a Phase I/II trial led by the University of Kansas Medical Center, focusing on participants previously treated with PD-1/PD-L1 inhibitors with or without chemotherapy. Participants receive atezolizumab as an intravenous infusion at a fixed dose of 1200 mg every three weeks. Pirfenidone is taken orally three times daily, with the dose increasing every two weeks from 267 mg to 801 mg. Treatment continues until disease progression. The study monitors for safety and effectiveness during cycles lasting 21 days each. During the study, participants will have regular visits for treatment administration and monitoring. Researchers will assess safety by tracking occurrences of severe toxicities from the start of treatment through three cycles. They will also measure tumor response, progression-free survival for up to two years, and overall survival at one year. Participants will undergo laboratory tests and imaging as needed to evaluate treatment effects and safety throughout the study period.
CONDITIONS
Brief Title
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal representative can provide written informed consent before any study procedures
- Willing and able to follow scheduled visits, treatment, lab tests, and study requirements
- Men or women aged 18 years or older with confirmed non-small cell lung cancer
- Previous history of other cancers allowed if no active treatment within 1 year
- Life expectancy of at least 6 months
- De novo stage IV or recurrent NSCLC without actionable mutations previously treated with PD-1/PD-L1 inhibitors or their combination with chemotherapy, with no more than 2 systemic regimens for metastatic disease
- At least 1 measurable tumor lesion
- PDL1 TPS score less than 1% or unknown; first-line treatment must be PD1/PDL1 inhibitor with chemotherapy
- Early stage NSCLC treated with chemotherapy then PD1/PDL1 inhibitor for recurrent disease
- Recurrent unresectable stage III NSCLC treated with chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease
- Eastern Cooperative Group Performance Status 0 to 2
- Able to swallow oral medications
- Adequate blood and organ function
You will not qualify if you...
- Any severe or uncontrolled medical condition that poses safety risks or interferes with the study
- Received investigational agents within 14 days or 5 half-lives before first treatment dose
- Known allergy to atezolizumab or pirfenidone
- Active medical or psychiatric illness interfering with treatment
- Uncontrolled diabetes
- Cardiac conditions including unstable angina, recent heart attack within 6 months, uncontrolled heart failure, or low left ventricular ejection fraction (<35%)
- History of severe toxicities from prior checkpoint inhibitor treatment
- Pregnant or breastfeeding
- Uncontrolled HIV infection
- Recent grade 2 or 3 radiation-induced lung injury within 3 months
- History of pneumonitis requiring systemic steroids or drug-induced pneumonitis
- Active pneumonitis seen on screening chest CT
- Smoking more than 1 pack per day
- Active peptic ulcer diagnosed within 4 weeks
- Active infection needing systemic treatment
- Current systemic antibacterial or antifungal use
- Prior monoclonal antibody within 4 weeks before study Day 1 (except denosumab)
- Not recovered to grade 1 or less from previous adverse events over 4 weeks earlier
- Concurrent use of other investigational agents
- Uncontrolled or symptomatic brain metastasis or leptomeningeal disease requiring steroids
- Use of strong CYP1A2 inhibitors
- History of cancer with active treatment within less than 1 year
- Active autoimmune diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive Atezolizumab as an intravenous infusion every 3 weeks and take Pirfenidone orally three times a day with dose increases until day 30.
Infusions every 3 weeks with oral medication daily; visits coincide with infusion schedule
Duration - Up to 2 years after end of treatment
Participants are monitored for progression-free survival and overall survival for up to 2 years after treatment ends.
Regular visits up to 1 year post-treatment for survival assessment
Trial Site Locations
Total: 2 locations
1
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States, 66205
Not Yet Recruiting
2
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205
Actively Recruiting
Research Team
K
KUCC Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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