Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC

University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting ID
parkview cancer institute (Other)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Anticipated Enrollment :
25 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

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
Other Names:
  • Pirfenidone
  • Outcome Measures

    Primary Outcome Measures

    1. Occurrence of Grade 3 toxicity [Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)]

      CTCAE v5.0

    2. Occurrence of Grade 4 toxicity [Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)]

      CTCAE v5.0

    Secondary Outcome Measures

    1. Overall response rate (ORR) of participants [Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)]

      RECIST 1.1

    2. Progression Free Survival (PFS) [From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment]

      RECIST 1.1

    3. 1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1 [Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days)]

      Medical records

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 The University of Kansas Cancer Center (KUCC) Fairway Kansas United States 66205
    2 The University of Kansas Cancer Center, Westwood Campus Kansas City Kansas United States 66205

    Sponsors and Collaborators

    • University of Kansas Medical Center
    • parkview cancer institute


    • Principal Investigator: Chao Huang, MD, The University of Kansas

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    University of Kansas Medical Center Identifier:
    Other Study ID Numbers:
    • IIT-2020-CAFs
    First Posted:
    Jul 13, 2020
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 21, 2022