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

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04467723
Collaborator
parkview cancer institute (Other)
25
2
1
20
12.5
0.6

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:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT04467723
    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:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 21, 2022