Description:
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.
Title
- Brief Title: Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
- Official Title: CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study
Clinical Trial IDs
- ORG STUDY ID:
IIT-2020-CAFs
- NCT ID:
NCT04467723
Conditions
- NSCLC Stage IV
- NSCLC, Recurrent
Interventions
Drug | Synonyms | Arms |
---|
Atezolizumab | Pirfenidone | Treatment |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment | Experimental | 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 | |
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Has uncontrolled diabetes
- Has any of the following cardiac diagnoses:
Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure
Left ventricular ejection fraction < 35%
- Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment
- Is pregnant or breast feeding
- Uncontrolled HIV
- Clinically diagnosed with grade 2 or 3 radiation-induced lung injury within the last 3
months prior to registering for the study
- Has a history of idiopathic pneumonitis that required systemic agent including steroid
- Has drug-induced pneumonitis
- Has evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Smoker of more than 1 pack / day
- Has active peptic ulcer diagnosed within 4 weeks of enrollment
- Active infection requiring systemic treatment
- Current use of systemic antibacterial or antifungal agent
- Prior monoclonal antibody within 4 weeks before study Day 1 Exception: The use of
denosumab
- Patient not recovered to ≤ Grade 1 from AEs due to agents administered more than 4
weeks earlier
- Concurrent use of other investigational agents
- Uncontrolled or symptomatic brain metastasis or leptomeningeal disease that requires
use of steroids
- Use of strong CYP1A2 inhibitors
- Previous history of cancer with active treatment within less than 1 year of enrollment
- Active auto-immune diseases
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of Grade 3 toxicity |
Time Frame: | Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) |
Safety Issue: | |
Description: | CTCAE v5.0 |
Secondary Outcome Measures
Measure: | Overall response rate (ORR) of participants |
Time Frame: | Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days) |
Safety Issue: | |
Description: | RECIST 1.1 |
Measure: | Progression Free Survival (PFS) |
Time Frame: | From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment |
Safety Issue: | |
Description: | RECIST 1.1 |
Measure: | 1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1 |
Time Frame: | Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days) |
Safety Issue: | |
Description: | Medical records |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | University of Kansas Medical Center |
Last Updated
August 26, 2021