Study on Canakinumab with Chemotherapy, Radiation, and Durvalumab for Lung Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04905316

This clinical trial is exploring whether adding canakinumab to standard chemotherapy, radiation, and durvalumab treatments is safe and effective for people with locally advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The purpose of this study is to determine if combining canakinumab with chemotherapy, radiation therapy, and the immunotherapy drug durvalumab can improve treatment outcomes for patients with locally advanced non-small cell lung cancer (NSCLC). Researchers aim to assess the safety and effectiveness of this combination therapy.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent and follow study requirements.
  • Age 18 or older.
  • Diagnosed with Stage IIIA-C non-small cell lung cancer (NSCLC).
  • Not suitable for surgery based on medical evaluations.
  • Eligible for combined chemotherapy and radiation therapy.
  • Confirmed NSCLC diagnosis through pathology review.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Suitable for a specific dose of radiation therapy.
  • Weigh more than 30 kg (about 66 pounds).
  • Have normal organ and bone marrow function, as shown by specific blood tests.
  • Women must be post-menopausal or have a negative pregnancy test if of childbearing potential.
  • Willing to comply with study procedures and have a life expectancy of at least 6 months.

Exclusion Criteria

  • Participating in another clinical trial with an investigational drug in the last 4 weeks.
  • Enrolled in another lung cancer study, unless it's observational.
  • Previous radiation that prevents further treatment.
  • Cannot take durvalumab.
  • Have certain autoimmune or inflammatory disorders, with some exceptions.
  • Recent treatment with certain antibodies or immune-targeting drugs.
  • Previous treatment with canakinumab.
  • Use of systemic immunosuppressive medication recently, with some exceptions.
  • Major surgery within 28 days before starting canakinumab.
  • History of other cancers needing treatment in the past 3 years, with some exceptions.
  • History of organ transplant.
  • Severe concurrent illnesses, including psychiatric disorders, liver disease, active infections, or heart disease.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Connective tissue disorders affecting the lungs or esophagus.
  • Known primary immunodeficiency.
  • Allergies to study drugs.
  • Received a live vaccine within 3 months before starting the study.

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