Adding Certolizumab to Chemotherapy and Nivolumab for Treating Lung Cancer That Can Be Surgically Removed
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
Inactive
ClinicalTrials ID:NCT04991025
This study is testing whether adding the drug certolizumab to standard chemotherapy and immunotherapy can help reduce inflammation and make the treatment more effective for people with lung cancer that can be treated with surgery.
Patient Parameters
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Program Overview
The study aims to find out if adding certolizumab to the usual chemotherapy and immunotherapy treatment for lung cancer can improve the effectiveness of the treatment. Researchers want to see if this combination is better, the same, or worse than the standard treatment alone.
Eligibility Criteria
Inclusion Criteria
- Have untreated stage II-III non-small cell lung cancer that can be surgically removed.
- Confirmed diagnosis of lung cancer at MSKCC.
- Be 18 years or older.
- Have a performance status score of 70 or higher, meaning you can care for yourself but may not be able to carry out normal activities or work.
- Have adequate bone marrow, liver, and kidney function as shown by specific blood tests.
- Have a negative test for tuberculosis.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Agree to use effective birth control during treatment and for at least 5 months after.
- Have at least one measurable tumor site.
- Be able to provide written informed consent.
- Have a negative HIV test, unless stable on treatment with a controlled viral load.
- Have a negative hepatitis B test or controlled hepatitis B.
- Can have other cancers if they do not interfere with the study treatment.
Exclusion Criteria
- Have a type of lung cancer that can be treated with a targeted therapy approved by the FDA.
- Have an allergy to platinum-based chemotherapy.
- Have used TNF-α inhibitors before.
- Have used systemic immunosuppressive medications recently, with some exceptions for low-dose or specific conditions.
- Have active or history of autoimmune diseases, with some exceptions for controlled conditions.
- Have lung diseases like idiopathic pulmonary fibrosis or active pneumonitis.
- Have significant hearing loss.
- Have active infections or untreated tuberculosis.
- Have significant heart disease or recent heart attack.
- Have had major surgery recently or need major surgery during the study.
- Have active hepatitis B or C, or HIV requiring treatment.
- Have active herpes zoster infection.
- Have uncontrolled high calcium levels.
- Have had other cancers recently, except for certain non-threatening types.
- Have had severe infections recently.
- Have had a stem cell or organ transplant.
- Have any condition that makes the study treatment unsafe.
- Have received live vaccines recently.
- Have used investigational therapies recently.
- Have used certain immune therapies before.
- Have severe allergies to study drugs or their components.
- Are pregnant, breastfeeding, or planning to become pregnant during or shortly after the study.
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