RecruitingPhase 1Phase 2NCT04467723

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

CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study


Sponsor

University of Kansas Medical Center

Enrollment

25 participants

Start Date

May 18, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — atezolizumab (an immunotherapy) and pirfenidone (an anti-fibrosis drug) — in patients with advanced non-small cell lung cancer (NSCLC) who have already received prior treatment including immunotherapy. The combination may help overcome resistance to immunotherapy. **You may be eligible if:** - You are 18 or older with confirmed non-small cell lung cancer - Your cancer does not have actionable mutations (like EGFR, ALK, or ROS-1) - You have already been treated with a PD-1 or PD-L1 immunotherapy (alone or with chemotherapy) and no more than 2 prior regimens for advanced disease - You have at least one measurable tumor - You are in reasonably good health (ECOG performance status 0-2) - You are able to swallow oral medications **You may NOT be eligible if:** - Your tumor has an actionable mutation that has targeted treatments available - You have active autoimmune disease requiring treatment - You have had more than 2 prior systemic therapy regimens - You have severe liver, kidney, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(2)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, United States

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

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NCT04467723


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