Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas

Inclusion Criteria

• •Previously untreated stage IV lung adenocarcinoma confirmed at MSKCC
• •Age 18 years or older
• •Karnofsky Performance Status ≥ 70
• •Patients with locally treated, stable, and/or asymptomatic brain metastases are eligible.
• •Adequate bone marrow, liver and renal function, as specified below:
• •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
• •Hemoglobin ≥ 8 g/dL
• •Platelets ≥ 100 x 109/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 or ≤ 5 x ULN if liver metastases are present
• •Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
• •Negative PPD test
• •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 3 months thereafter
• •Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors
• •Archival tissue (10 Unstained Slides - 5 micron sections) from a core biopsy performed and received within 30 days before signing consent or ability to have a fresh core biopsy performed
• •Biopsy cannot be from any cytology or bone specimen
• •Biopsy site must be amenable to re-biopsy at the end of the study
• •Ability to provide written, informed consent