Study on Induction Chemo-Nivo for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Ralph G Zinner

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06003075

This clinical trial is testing a combination therapy to see how well it works and how safe it is for patients with Stage III lung cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

The aim of this study is to find out how effective and safe a combination treatment is for patients with Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. Researchers want to see how well the cancer responds to this treatment.

Eligibility Criteria

Inclusion Criteria

  • Have Stage IIIA-IIIC non-small cell lung cancer that cannot be removed by surgery and has not been treated before.
  • PD-L1 levels can be between 0-100%.
  • Do not have specific genetic changes in EGFR, ALK, or ROS1 genes, or these changes are unknown.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have good organ and bone marrow function.
  • Have enough lung function to handle potential lung surgery.
  • If HIV-positive, be on effective treatment with an undetectable viral load in the last 6 months.
  • If you have chronic hepatitis B, the virus must be undetectable with treatment.
  • If you had hepatitis C, you must be cured or have an undetectable viral load if still on treatment.
  • Have no other cancers that would interfere with this study.
  • Have a heart function assessment of class 2B or better.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have participated in another study with an experimental drug or device within the last 2 weeks.
  • Have had any previous radiation therapy to the lungs.
  • Have had any previous treatment for non-small cell lung cancer.
  • Have used any drugs targeting immune checkpoints or T-cell pathways.
  • Have had severe allergic reactions to monoclonal antibodies or study drug components.
  • Have primary tumors in the esophagus or Pancoast tumors.
  • Have tumors that cannot be surgically removed.
  • Have a history of allergic reactions to drugs similar to Nivolumab.
  • Have an active or past autoimmune disease or conditions requiring steroids or immunosuppressive drugs.
  • Need ongoing systemic steroids greater than 10mg of prednisone.
  • Have had other cancers in the past.
  • Have a history of interstitial lung disease.
  • Require continuous oxygen support.
  • Have received live vaccines within 4 weeks before starting the study.
  • Have an active infection needing treatment.
  • Have uncontrolled illnesses or psychiatric conditions that affect study participation.
  • Are pregnant or breastfeeding.

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