Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Jul 8, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a medication called pirfenidone to another medication called atezolizumab can help improve treatment outcomes for patients with advanced non-small cell lung cancer (NSCLC) that has come back after previous treatments. The researchers hope that this combination will work better against the tumors and help patients who may have developed resistance to other therapies.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with stage IV or recurrent NSCLC. They should have already received certain types of treatments before and have measurable disease. Participants will need to be able to attend scheduled visits and take medications as directed. Those who join the study will receive the combination treatment and be monitored closely for effects and side effects. It’s important to note that this trial is currently recruiting participants, and anyone interested should discuss it with their doctor to see if they may qualify.

Gender

ALL

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