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

Exclusion criteria

• Hypersensitivity to platinum agents
• Ongoing use of investigational agents or use of investigational agents within the last four weeks
• Prior use of agents for TNF-alpha blockade
• History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis
• Baseline hearing deficit (CTCAE version 4.0 grade 2 or higher)
• Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush
• Active tuberculosis or untreated, latent tuberculosis

o If a patient has signs, symptoms, or a history suggestive of active tuberculosis, evaluation by an infectious disease physician will be required and active tuberculosis ruled-out prior to enrollment.

• Acute or chronic Hepatitis B or C infection
• Known HIV infection requiring antiretroviral medications and those with AIDS
• Active herpes zoster infection
• Non-healed infected skin ulcers
• History of myocardial infarction or unstable angina within the past 12 months
• Ongoing use of other immunosuppressive medications, including oral steroids and excluding topical steroids
• Women who are breastfeeding Prior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast