Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
Kansas City, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center