NSCLC, Recurrent, NSCLC Stage IV
Conditions
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.
Interventions
DRUGAtezolizumab
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
Sponsors
University of Kansas Medical Center
parkview cancer institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTKUCC Navigator
PRINCIPAL_INVESTIGATORChao Huang, MD
The University of Kansas
Outcome results
None listed