Phase 2 Trial of Neoadjuvant Nivolumab + Platinum-based Chemotherapy + Certolizumab in Patients With Resectable Stages II-III Lung Cancers
The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.
• Untreated stage II-III (AJCC 8th edition) non-small cell lung cancers with operable and resectable disease determined by a thoracic surgeon
• Histologic confirmation of disease at MSKCC
• Age 18 years or older
• Karnofsky Performance Status ≥ 70
• Adequate bone marrow, liver and renal function, as specified below:
‣ Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9 /L
⁃ Lymphocyte count ≥0.5 x10\^9/L (500/µL)
⁃ Hemoglobin ≥ 9 g/dL
⁃ Platelets ≥ 100 x 10\^9 /L
⁃ Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
⁃ AST and ALT ≤ 2.5 x ULN
⁃ Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
⁃ Serum albumin ≥25 g/L (2.5 g/dL)
⁃ For patients not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 x ULN
⁃ For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative PPD test or interferon-gamma release assay (including but not limited to QuantiFERON-TB Gold)
• For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
• Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 5 months thereafter
• Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors 1.1
• Ability to provide written, informed consent. Legally Authorized Representatives are permitted.
• Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ³ 200/µL, and have an undetectable viral load
• Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. Note: The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.
• Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.