Study of Atezolizumab and Pirfenidone Combination Therapy for Advanced and Recurrent Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating whether adding pirfenidone to atezolizumab increases anti-tumor activity and reduces treatment resistance in people with stage 4 and recurrent non-small cell lung cancer. This study is a Phase III trial led by the University of Kansas Medical Center, focusing on participants previously treated with PD-1PD-L1 inhibitors with or without chemotherapy. Participants receive atezolizumab as an intravenous infusion at a fixed dose of 1200 mg every three weeks. Pirfenidone is taken orally three times daily, with the dose increasing every two weeks from 267 mg to 801 mg. Treatment continues until disease progression. The study monitors for safety and effectiveness during cycles lasting 21 days each. During the study, participants will have regular visits for treatment administration and monitoring. Researchers will assess safety by tracking occurrences of severe toxicities from the start of treatment through three cycles. They will also measure tumor response, progression-free survival for up to two years, and overall survival at one year. Participants will undergo laboratory tests and imaging as needed to evaluate treatment effects and safety throughout the study period.

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