Atezolizumab and Pirfenidone for Stage 4 or Recurrent NSCLC
This study is testing if adding pirfenidone to atezolizumab can help treat stage 4 or recurrent non-small cell lung cancer (NSCLC). Atezolizumab is given through a vein every three weeks, and pirfenidone is taken by mouth three times a day, with the dose increasing over time. Researchers want to see if this combination increases anti-tumor activity and reduces treatment resistance. You may be able to join if you are at least 18 years old and have been diagnosed with NSCLC. The study will look at how safe the treatment is by tracking serious side effects (Grade 3 or 4 toxicity) during the first three cycles of treatment. The current recruitment status is unclear.
- Study design
- This study is testing a new drug combination in about 25 participants with non-small cell lung cancer.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety outcomes are measured during the first three cycles of treatment (each cycle is 21 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04467723
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Kansas Medical CenterInvestigator-initiated
~25 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Atezolizumab
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Grade 3 toxicity
Measured over Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesKansas2
Study leadership
- Chao Huang, MD · PRINCIPAL_INVESTIGATOR · The University of Kansas
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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:
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
What this trial measures
- Occurrence of Grade 3 toxicityCycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0
- Occurrence of Grade 4 toxicityCycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
CTCAE v5.0