Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
- Registration Number
- NCT04467723
- Lead Sponsor
- University of Kansas Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Atezolizumab 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
- Primary Outcome Measures
Name Time Method Occurrence of Grade 3 toxicity Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) CTCAE v5.0
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
Name Time Method Overall response rate (ORR) of participants Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) RECIST 1.1
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
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
Trial Locations
- Locations (2)
The University of Kansas Cancer Center (KUCC)
🇺🇸Fairway, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus
🇺🇸Kansas City, Kansas, United States