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