Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer

Inclusion Criteria:

• Patients must have histologically confirmed non-small cell lung cancer (NSCLC) which is accessible to biopsy.
• Patient must have ECOG Performance Status of 0, 1, or 2.
• Life expectancy greater than 12 weeks.
• Patient must have adequate bone marrow, renal and hepatic function as defined in the protocol.
• Completed all prior therapy at least 3 weeks prior to registration and be adequately recovered from that therapy.
• Must be at least 18 years of age.
• Meet pre-entry requirements as specified in Section 7.0.
• Female patients of child-bearing potential must have a negative serum pregnancy test prior to study entry.
• Patients of child-bearing potential must agree to use an effective form of contraception while on study and for 3 months following completion of study treatment.
• Patient must not have more than one prior chemotherapy regimen.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

• Chronic treatment with systemic steroids or other immunosuppressive agents.
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
• A known history of HIV seropositivity.
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
• Patients with an active, bleeding diathesis or an oral anti-vitamin K medication (except low dose coumadin).
• Known hypersensitivity to everolimus, sirolimus, or any of its excipients.
• Patient is pregnant or breast-feeding.
• Patient has intercurrent illness including, but not limited to: ongoing active or severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, myocardial infarction within 6 months, uncontrolled diabetes mellitus, chronic liver or renal disease, active upper GI tract ulceration or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient is unable to swallow RAD001.
• History of other invasive malignancies, with the exception of non-melanoma skin cancer, if there is any evidence of the malignancy being present within the past 5 years.
• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Symptoms may include any reaction such as bronchospasm, generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.
• Patient has received treatment with an investigational agent within 4 weeks of registration.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.