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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States
NOT_YET_RECRUITINGThe University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
RECRUITINGOccurrence of Grade 3 toxicity
CTCAE v5.0
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
Occurrence of Grade 4 toxicity
CTCAE v5.0
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
Overall response rate (ORR) of participants
RECIST 1.1
Time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)
Progression Free Survival (PFS)
RECIST 1.1
Time frame: From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment
1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1
Medical records
Time frame: Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days)
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