Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: RAD001
Intervention description: Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.
Intervention MeSH terms: Everolimus
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer

Summary:

      This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer
      will be treated with RAD001 to evaluate the target effects of this compounds on relevant
      molecular pathways and on the 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) uptake
      of the tumor by a positron emission tomography (PET) scan at baseline and immediately prior
      to surgery. The safety profile of RAD001 will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have histologically confirmed Stage I-IIIA non-small cell lung cancer
             (NSCLC) which is accessible to biopsy.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.

          -  Life-expectancy greater than 6 months.

          -  Adequate bone marrow, renal, hepatic, pulmonary and cardiac function as defined in the
             protocol.

          -  Patient must be at least 18 years of age.

          -  Must meet pre-entry requirements for timing of study parameters as specified in
             section 7.0.

          -  Female patients of child-bearing potential must have a negative serum pregnancy test
             within 48 hours of study initiation and be non-lactating.

          -  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.

          -  The use of granulocyte-colony stimulating factor (G-CSF) will be permitted in study
             participants.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.

        Exclusion Criteria:

          -  Patient has received previous treatment for NSCLC.

          -  Known hypersensitivity to everolimus, sirolimus, or any of its excipients.

          -  Patient is pregnant or breast-feeding.

          -  Patient has incurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Patient is unable to swallow RAD001 tablet.

          -  History of other invasive malignancies, with the exception of non-melanoma skin
             cancer, are excluded if there is any evidence of the malignancy being present within
             the past five 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.

          -  Final eligibility for a clinical trial is determined by the health professionals
             conducting the trial.