combination of atezolizumab and pirfenidone in second-line and beyond nsclc

Conditions: NSCLC Stage IV; NSCLC, Recurrent

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.


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