Study on Combining Atezolizumab and Pirfenidone for Advanced Non-Small Cell Lung Cancer

Sponsor: University of Kansas Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04467723

This clinical trial is exploring whether adding the drug pirfenidone to atezolizumab can enhance the treatment effects and reduce resistance in patients with stage 4 or recurrent non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The aim of this study is to determine if combining the drug pirfenidone with atezolizumab can improve the effectiveness of treatment and reduce resistance in patients with advanced or returning non-small cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

  • Able to provide written consent to participate in the study.
  • Willing to attend scheduled visits and follow the treatment plan.
  • Men or women aged 18 or older with confirmed non-small cell lung cancer.
  • Previous cancer history is allowed if no active treatment for that cancer in the past year.
  • Expected to live at least 6 more months.
  • Stage IV or returning NSCLC without certain mutations, previously treated with specific therapies, and no more than two treatment regimens for metastatic disease.
  • At least one tumor that can be measured.
  • Specific PDL1 score requirements for first-line treatment.
  • Early stage NSCLC treated with chemotherapy and then immunotherapy for returning disease.
  • Recurrent stage III NSCLC treated with chemoradiation and maintenance immunotherapy.
  • ECOG performance status of 0 to 2, indicating good overall health.
  • Able to swallow pills.
  • Adequate blood and organ function.

Exclusion Criteria

  • Severe or uncontrolled medical conditions that pose safety risks or affect study participation.
  • Recent use of investigational drugs.
  • Allergic to atezolizumab or pirfenidone.
  • Active medical or psychiatric conditions interfering with treatment.
  • Uncontrolled diabetes.
  • Certain heart conditions, such as recent heart attack or severe heart failure.
  • History of severe side effects from previous immunotherapy.
  • Pregnant or breastfeeding.
  • Uncontrolled HIV.
  • Recent severe lung injury from radiation.
  • History of lung inflammation requiring treatment.
  • Active lung inflammation on a CT scan.
  • Smoking more than one pack a day.
  • Recent active peptic ulcer.
  • Active infection needing treatment.
  • Current use of antibiotics or antifungal medications.
  • Recent use of certain antibodies, except denosumab.
  • Not fully recovered from previous treatment side effects.
  • Use of other investigational drugs.
  • Uncontrolled brain metastasis needing steroids.
  • Use of strong CYP1A2 inhibitors.
  • Recent active cancer treatment within the past year.
  • Active autoimmune diseases.

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