RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study

Quick Facts

Study Start:2022-05-18

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04467723

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

KUCC Navigator

CONTACT

9135883671

KUCC_Navigation@kumc.edu

Principal Investigator

Chao Huang, MD

PRINCIPAL_INVESTIGATOR

The University of Kansas

Study Locations (Sites)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, 66205

United States

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Chao Huang, MD, PRINCIPAL_INVESTIGATOR, The University of Kansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-18

Study Completion Date2025-08

Study Record Updates

Study Start Date2022-05-18

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

NSCLC Stage IV
NSCLC, Recurrent