Recruiting
Phase 1
Phase 2

Atezolizumab & Pirfenidone

Sponsor:

University of Kansas Medical Center

Code:

NCT04467723

Conditions

NSCLC Stage IV

NSCLC, Recurrent

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atezolizumab

Study Details

Brief 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.

Conditions

NSCLC Stage IV

NSCLC, Recurrent

Study ID

NCT04467723

Start date

May 18, 2022

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks.

Pirfenidone (Esbriet) orally (PO) with food according to this schedule:

Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID

Interventions

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 measure

  • Occurrence of Grade 3 toxicity [ Time Frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) ]
  • Occurrence of Grade 4 toxicity [ Time Frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) ]

Central Contacts and Locations

Central contacts

Locations

The University of Kansas Cancer Center, Westwood Campus

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-01-28.