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
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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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