NCT04467723 · University of Kansas Medical Center
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
What this study 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.
View original scientific description
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.
Interventions
DRUG
Atezolizumab
Atezolizumab is given as an intravenous infusion at 1200 mg every 3 weeks. Pirfenidone is taken by mouth 3 times a day with the dose increasing every 2 week until day 30
Primary outcome measures
Occurrence of Grade 3 toxicity
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0
Occurrence of Grade 4 toxicity
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant or legal representative is able to provide written informed prior to performing any protocol-related procedures
- Is willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study
- Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer
- Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
- Life expectancy of at least 6 months
- De novo stage IV or recurrent NSCLC without actionable mutation (e.g. EGFR/ ALK/ ROS-1) that was previously treated with either PD-1 / PD-L1 or the combination of PD1/PDL1 and cytotoxic chemotherapy, no more than 2 systemic regimens for metastatic disease with measurable disease \*. Maintenance therapy will be considered part of the 1 regimen
- At least 1 measurable lesion
- PDL1 TPS score less than 1% or unknown: first-line must be PD1/PDL1 inhibitor in
Where
- Fairway, Kansas
- Kansas City, Kansas
Collaborators
parkview cancer institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations