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

NCT04467723 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT-2020-CAFs
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

NSCLC Stage IV; NSCLC, Recurrent

Outcome Measures

Primary Outcomes (2)

• Occurrence of Grade 3 toxicity

  CTCAE v5.0

  Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)

• Occurrence of Grade 4 toxicity

  CTCAE v5.0

  Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)

Secondary Outcomes (3)

• Overall response rate (ORR) of participants

  Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)

• Progression Free Survival (PFS)

  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

  Cycle 1 day 1 up to 1 year post-Cycle 1 day 1 (Each cycle is 21 days)

Study Arms (1)

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

Drug: Atezolizumab

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

Also known as: Pirfenidone

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• parkview cancer institute: collaborator

Study Sites (2)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, 66205, United States

NOT YET RECRUITING

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Interventions

atezolizumab; pirfenidone

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chao Huang, MD

  The University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KUCC Navigator

CONTACT

9135883671; KUCC_Navigation@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: May 18, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)