The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

Exclusion Criteria

• •Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
• •Prior malignancies, except: cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or any other curatively treated malignancy with no evidence of disease recurrence for at least 2 years.
• •Presence of uncontrolled brain or leptomeningeal metastases.
• •Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v 4.0 except if due to trauma.
• •Other serious illness or medical condition, including but not limited to: congestive heart failure;myocardial infarction within 6 months;significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician; infection requiring I.V. antibiotics; tuberculosis with ongoing therapy at study entry, superior vena cava syndrome, except if controlled with radiation, active peptic ulcer disease; unstable diabetes mellitus;any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease.
• •Hypercalcemia requiring therapeutic intervention.
• •Clinically significant ascites and/or pericardial effusion.
• •Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
• •Concurrent treatment with other investigational drugs.
• •Patients known to harbor sensitizing EGFR mutations in exons 18, 19 and 21. Patients with resistance mutation in exon 20 will be allowed to enroll i.e. T790M and D770. The rare patient who has both a resistance mutation and a sensitizing mutation at the diagnoses will be excluded in the protocol.
• •Patients whose tissue submission is not of adequate size to perform molecular testing will be excluded.
• •Patients known to have translocations of ALK will also be excluded; however, testing for ALK translocation prior to study entry is not mandated.