Actively Recruiting
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
Led by University of Kansas Medical Center · Updated on 2026-01-28
25
Participants Needed
2
Research Sites
271 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
The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants.
CONDITIONS
Official 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, treatments, lab tests, and study requirements
- Men or women aged 18 years or older with confirmed non-small cell lung cancer
- Previous non-lung cancers allowed if no active treatment in past year
- Life expectancy of at least 6 months
- Stage IV or recurrent NSCLC without actionable mutation, previously treated with PD-1/PD-L1 inhibitors or combination with chemotherapy, with no more than 2 systemic treatments for metastatic disease
- At least one measurable tumor lesion
- PDL1 TPS score less than 1% or unknown, with prior first-line PD1/PDL1 inhibitor combined with chemotherapy
- Early stage (I-III) NSCLC treated with chemotherapy and PD1/PDL1 inhibitor for recurrence
- Recurrent unresectable stage III NSCLC treated with chemoradiation and PD1/PDL1 inhibitor, with measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 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 affects study compliance
- Use of investigational drugs within 14 days or 5 half-lives before starting study treatment
- Known allergy to atezolizumab or pirfenidone
- Active medical or psychiatric illness interfering with treatment
- Uncontrolled diabetes
- Certain heart conditions including unstable angina, recent heart attack, uncontrolled heart failure, or low heart function
- History of severe toxicities to prior checkpoint inhibitor treatments
- Pregnancy or breastfeeding
- Uncontrolled HIV infection
- Recent moderate to severe radiation-induced lung injury
- History of pneumonitis requiring systemic treatment
- Drug-induced pneumonitis or active pneumonitis on screening CT scan
- Smoking more than one pack per day
- Active peptic ulcer within 4 weeks before enrollment
- Active infection needing systemic treatment
- Current use of systemic antibacterial or antifungal medication
- Recent use of monoclonal antibodies except denosumab
- Not recovered to mild or better from previous treatment side effects
- Use of other investigational agents concurrently
- Uncontrolled or symptomatic brain metastases requiring steroids
- Use of strong CYP1A2 inhibitors
- Recent active cancer treatment within 1 year
- Active autoimmune diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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