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

Part of paid clinical trials in Fairway, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT04467723
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • NSCLC Stage IV
  • NSCLC, Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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

Study Details

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.

Key Dates

Start date
May 18, 2022
Status verified
Jan 2026
Primary completion
Jan 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks. Pirfenidone (Esbriet) orally (PO) with food according to this schedule: Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID

Primary Outcome Measure

Occurrence of Grade 3 toxicity [ Time Frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Kansas Cancer Center (KUCC)FairwayKansas66205
KUCC Navigator
[email protected]
913-588-3671
The University of Kansas Cancer Center, Westwood CampusKansas CityKansas66205
KUCC Navigation
[email protected]
913-588-3671

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By research site
The University of Kansas Cancer Center (KUCC)· Fairway, KSThe University of Kansas Cancer Center, Westwood Campus· Kansas City, KS

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