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NSCLC Stage IVPhase 1/2NCT04467723

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

A Phase 1/2 study testing Atezolizumab in people with NSCLC Stage IV and NSCLC, Recurrent, run by University of Kansas Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC Stage IV, NSCLC, Recurrent
What is being tested?
Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
18 May 2022to Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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:
Show all 25Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

KUCC Navigator contact

9135883671

KUCC_Navigation@kumc.edu

United States2 sites, 2 recruiting

  • The University of Kansas Cancer Center (KUCC)

    Fairway, Kansas, 66205

    KUCC Navigator, 913-588-3671, kucc_navigation@kumc.edu

    Not yet recruiting

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas, 66205

    KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Pirfenidone

    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 groups in NCT04467723
Study groupRoleWhat they receive
TreatmentExperimentalAtezolizumab (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
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Grade 3 toxicity

    CTCAE v5.0

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

  2. Occurrence of Grade 4 toxicity

    CTCAE v5.0

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

Secondary outcomes (3)

  1. Overall response rate (ORR) of participants

    RECIST 1.1

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

  2. Progression Free Survival (PFS)

    RECIST 1.1

    Measured: From Cycle 1 day 1 (Each cycle is 21 days) for up to 2 years after end of treatment

  3. 1-year overall survival (OS) rate: Proportion of participants alive at 1 year from Cycle 1 day 1

    Medical records

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start18 May 2022
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04467723
Sponsor's protocol ID
IIT-2020-CAFs
Status last verified
Jan 2026
First submitted
8 Jul 2020
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atezolizumab in people with NSCLC Stage IV and NSCLC, Recurrent, run by University of Kansas Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact KUCC Navigator (9135883671, KUCC_Navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Grade 3 toxicity (time frame: Cycle 1 day 1 to Cycle 3 day 1 (Each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04467723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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