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

NCT ID: NCT04467723

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2027-08-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Pirfenidone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

parkview cancer institute

UNKNOWN

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao Huang, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Kansas

Locations

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, United States

Site Status: NOT_YET_RECRUITING

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

KUCC Navigator

Role: CONTACT

KUCC_Navigation@kumc.edu

9135883671

Facility Contacts

KUCC Navigator

Role: primary

kucc_navigation@kumc.edu

913-588-3671

KUCC Navigation

Role: primary

kucc_navigation@kumc.edu

913-588-3671

Other Identifiers

IIT-2020-CAFs

Identifier Type: -

Identifier Source: org_study_id