Clinical Drug Experience Knowledgebase

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