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