RecruitingPhase 1 / Phase 2NCT04467723
Official study titleCombination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
Study summary
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.
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Key things to know
Main goalTreatment
This describes the study’s primary purpose.
What is being studiedAtezolizumab
The study team can explain what participation involves.
Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Metastatic or stage IV
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 28, 2026 · Source: ClinicalTrials.gov
Is enrollment open?Recruiting
The study is currently accepting participants.
What kind of study?Phase 1 / Phase 2
Interventional
Where is it offered?2 U.S. locations
Locations may change over time.
Who runs it?University of Kansas Medical Center
Study sponsor
Study overview
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of Kansas Medical Center
- Interventions being studied
- Drug: Atezolizumab
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How this study is categorized
These labels come from structured fields and exact terms in the public record.
Disease setting
Treatment approach
Study topics
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion 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 combination with chemotherapy
- Early stage (I-III) NSCLC treated with adjuvant or neoadjuvant chemotherapy then PD1/PDL1 inhibitor treatment for recurrent disease
- Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease
- Eastern Cooperative Group (ECOG) Performance Status 0 - 2
- Is able to swallow oral medications
- Adequate hematologic function
- Adequate organ function
Reasons someone may not be able to joinExclusion criteria
- The presence of any other concurrent severe and/or uncontrolled medical condition that would, in the investigator or treating physician's judgement, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol
- Has received investigational agents within 14 days or 5 half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment
- Has a known hypersensitivity to atezolizumab or pirfenidone
- Has active medical or psychiatric illness that would interfere with the study treatment
- Has uncontrolled diabetes
- Has any of the following cardiac diagnoses: Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure Left ventricular ejection fraction \< 35%
- Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment
- Is pregnant or breast feeding
- Uncontrolled HIV
- Clinically diagnosed with grade 2 or 3 radiation-induced lung injury within the last 3 months prior to registering for the study
- Has a history of idiopathic pneumonitis that required systemic agent including steroid
- Has drug-induced pneumonitis
- Has evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Smoker of more than 1 pack / day
- Has active peptic ulcer diagnosed within 4 weeks of enrollment
- Active infection requiring systemic treatment
- Current use of systemic antibacterial or antifungal agent
- Prior monoclonal antibody within 4 weeks before study Day 1 Exception: The use of denosumab
- Patient not recovered to ≤ Grade 1 from AEs due to agents administered more than 4 weeks earlier
- Concurrent use of other investigational agents
- Uncontrolled or symptomatic brain metastasis or leptomeningeal disease that requires use of steroids
- Use of strong CYP1A2 inhibitors
- Previous history of cancer with active treatment within less than 1 year of enrollment
- Active auto-immune diseases
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- The University of Kansas Cancer Center (KUCC)Fairway, Kansas
- The University of Kansas Cancer Center, Westwood CampusKansas City, Kansas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 28, 2026. Always confirm current availability with the study team.