RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding pirfenidone to atezolizumab helps fight lung cancer and keeps treatment from losing its effect. It is for adults with stage 4 or returning non-small cell lung cancer who have already had treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with non-small cell lung cancer confirmed by tissue or cell tests.
  • You or your legal representative must give written consent. You must be able to follow the study schedule and testing.
  • Have stage 4 or returning cancer with no gene change that can be targeted with treatment, such as EGFR, ALK, or ROS-1. Have at least one tumor that can be measured.
  • Have had PD-1 or PD-L1 treatment, which helps the immune system fight cancer, alone or with chemotherapy. Have had no more than 2 drug treatment plans for cancer that has spread; maintenance treatment counts as part of the same plan.
  • If your PD-L1 tumor test score is below 1% or unknown, your first treatment must have included both immune treatment and chemotherapy.
  • Certain earlier-stage cancers may qualify: stage 1–3 cancer treated with chemotherapy around surgery, then immune treatment when it returned; or returning stage 3 cancer that cannot be removed by surgery, treated with chemotherapy, radiation, and then maintenance immune treatment.
  • Be expected to live at least 6 months, be able to do at least some daily activities, swallow pills, and have blood counts and organ function good enough for the study.
  • If you have had another type of cancer, you must not have had active treatment for it within the past year.

Who can't join

  • Have a serious or uncontrolled illness, or a mental health condition that would make study treatment unsafe or hard to follow. This includes uncontrolled diabetes, uncontrolled HIV, or an active disease in which the immune system attacks the body.
  • Have unstable chest pain, a heart attack within 6 months, uncontrolled heart failure, or a heart pumping strength below 35%.
  • Be allergic to either study drug, have had severe side effects from earlier checkpoint immune treatment, or still have more than mild side effects from drugs given over 4 weeks ago.
  • Have moderate or severe radiation-related lung injury within the past 3 months; past lung inflammation of unknown cause that needed whole-body treatment, such as steroids; drug-related lung inflammation; or active lung inflammation on the screening CT scan. Smoke more than 1 pack a day.
  • Be pregnant or breastfeeding, have an active stomach or upper bowel ulcer diagnosed within 4 weeks, or have received active treatment for another cancer within the past year.
  • Have an active infection needing whole-body treatment, or currently use whole-body antibiotics or antifungal drugs. Use medicines that strongly block CYP1A2, a protein that breaks down some drugs.
  • Use another study drug now or have used one too recently: within 14 days or 5 drug half-lives, whichever is longer. A half-life is the time it takes for half the drug to leave the body. Have received an antibody drug within 4 weeks, except denosumab.
  • Have uncontrolled or symptom-causing cancer spread to the brain, or cancer in the lining around the brain and spinal cord that needs steroid treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

KS