Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Signed informed consent
Confirmed diagnosis of Stage IV non-squamous non-small cell lung cancer
CT of the chest, abdomen, and pelvis which shows metastatic disease. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
Age ≥ 18 years
Normal blood function levels as evidenced by laboratory tests.
Adequate liver, kidney and blood chemistry function.
Adequate blood clotting levels
Urine dipstick levels of protein must be between 0-1+.
Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x IULN. Testing must be performed within 14 days prior to enrollment.
The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
No prior treatment with everolimus. Prior treatment with pemetrexed or carboplatin is allowed, provided no disease progression with prior exposure to drugs. Prior treatment with bevacizumab allowed.

Exclusion Criteria:

Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Clinically significant cardiac event such as Myocardial infarction
Inadequately controlled high blood pressure
Active gastrointestinal disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for IVplacement; prior surgical procedures affecting absorption; or active peptic ulcer disease
Presence of fluid accumulation which cannot be controlled by drainage
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
History of stroke within 6 months prior to enrollment
History of significant vascular disease within 6 months prior to enrollment(i.e., aortic aneurysm)
No unusual bleeding or inability to clot (assuming not on anti-coagulation); patients with a history of DVT and/pr pulmonary embolism are excluded
Serious non-healing wound, ulcer, or bone fracture
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1.
Untreated brain metastases Radiation treatment than 28 days prior to registration. Side effects due to radiation therapy must have resolved.
Coughing up of blood
Excessive protein in your urine
Abnormal levels of lipids in your blood
Previous or current malignancies within the last 3 years, with the exception of cervical cancer and adequately treated basal cell or squamous cell carcinoma of the skin
Prior treatment with any investigational drug within the preceding 4 weeks prior to enrollment
Patients receiving chronic, systemic treatment with corticosteroids or another immunotherapy. Topical or inhaled corticosteroids are allowed.
Patients must not receive immunization with attenuated live vaccines within one week prior to study enrollment or during study period.
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation.
HIV positive
Impairment of stomach or intestinal function or stomach or intestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus.
Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients