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

Who is this study for? Patients with stage 4 and recurrent non-small cell lung cancer
What treatments are being studied? Atezolizumab
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Life expectancy of at least 6 months

• De novo stage IV or recurrent NSCLC without actionable mutation (e.g. EGFR/ ALK/ ROS-1) that was previously treated with either PD-1 / PD-L1 or the combination of PD1/PDL1 and cytotoxic chemotherapy, no more than 2 systemic regimens for metastatic disease with measurable disease \*. Maintenance therapy will be considered part of the 1 regimen

• At least 1 measurable lesion

• PDL1 TPS score less than 1% or unknown: first-line must be PD1/PDL1 inhibitor in combination with chemotherapy

• Early stage (I-III) NSCLC treated with adjuvant or neoadjuvant chemotherapy then PD1/PDL1 inhibitor treatment for recurrent disease

• Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease

• Eastern Cooperative Group (ECOG) Performance Status 0 - 2

• Is able to swallow oral medications

• Adequate hematologic function

• Adequate organ function

Locations
United States
Kansas
The University of Kansas Cancer Center (KUCC)
NOT_YET_RECRUITING
Fairway
The University of Kansas Cancer Center, Westwood Campus
RECRUITING
Kansas City
Contact Information
Primary
KUCC Navigator
KUCC_Navigation@kumc.edu
9135883671
Time Frame
Start Date: 2022-05-18
Estimated Completion Date: 2027-08
Participants
Target number of participants: 25
Treatments
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
Sponsors
Leads: University of Kansas Medical Center
Collaborators: parkview cancer institute

This content was sourced from clinicaltrials.gov