Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Atezolizumab
DrugAtezolizumab 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
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of Grade 3 toxicity
CTCAE v5.0
Time frame
Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)2
Occurrence of Grade 4 toxicity
CTCAE v5.0
Time frame
Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)Secondary outcomes
1
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)2
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 treatment3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
parkview cancer institute
Collaborator
Source ClinicalTrials.gov