Clinical trial NCT01063478 (phase 1, status: terminated)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: rad001 (in addition to standard radiation and chemotherapy)
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed NSCLC of any type

          -  Disease stage. Patients with unresectable stage II, stage III, and Mx are eligible.
             This includes patients who are being considered as surgical candidates after induction
             chemoradiation. Patients with Mx or M1 disease whose life-span and prognosis are felt
             to be dominated by the locoregional disease in the chest and are candidates for
             chemoradiotherapy are also eligible.

          -  Patients with pleural effusion that is transudative, cytologically negative and non-
             bloody are eligible if the radiation oncologist feels that the tumor can be
             encompassed within a reasonable field of radiotherapy.

          -  If a pleural effusion is of such a small size that a thoracentesis is not possible,
             then the patient is eligible

          -  Patients with malignant pleural or pericardial effusions are not eligible

          -  Patients will be eligible with or without measurable or evaluable disease. Patients
             with both measurable and evaluable disease will be evaluated for criteria for
             measurable disease

          -  Measurable disease is defined according to RECIST criteria

          -  Evaluable disease is defined as lesions apparent on CT which do not fit criteria for
             measurability.

          -  Ill defined masses associated with post obstructive changes

          -  Mediastinal or hilar adenopathy measurable in only one dimension

          -  Age ≥ 18 years

          -  ECOG performance status ≤ 2

          -  Life expectancy > 6 months

          -  Adequate lung function as defined by an 02 saturation that is ≥ 90% on room air

          -  Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L,
             Hb >9 g/dL Adequate liver function as shown by: serum bilirubin ≤ 1.5 x ULN, ALT and
             AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases), INR and PTT ≤1.5.
             (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a
             stable dose of LMW heparin for >2 weeks at time of randomization.)

          -  Adequate renal function: serum creatinine ≤ 1.5 x ULN

          -  Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x
             ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only
             be included after initiation of appropriate lipid lowering medication.

          -  Informed consent must be obtained from all patients prior to beginning therapy.
             Patients should have the ability to understand and the willingness to sign a written
             informed consent document.

          -  Radiation therapy requirements: Patient must have a completed treatment plan approved
             by the protocol review team

        Exclusion Criteria:

          -  Patients who have received prior radiation or chemotherapy for the current diagnosis
             of NSCLC (patients who received surgery only for a prior NSCLC are eligible if the
             current diagnosis is felt to represent a new primary, and the PFT's would allow for
             concurrent chemoradiation)

          -  Patients, who have had a major surgery or significant traumatic injury within 4 weeks
             of start of study drug, patients who have not recovered from the side effects of any
             major surgery (defined as requiring general anesthesia) or patients that may require
             major surgery during the course of the study

          -  Prior treatment with any investigational drug within the preceding 4 weeks

          -  Patients receiving chronic, systemic treatment with corticosteroids or another
             immunosuppressive agent. Topical or inhaled corticosteroids are allowed.

          -  Patients should not receive immunization with attenuated live vaccines within one week
             of study entry or during study period

          -  Other malignancies within the past 3 years except for adequately treated carcinoma of
             the cervix, basal or squamous cell carcinomas of the skin, or breast DCIS, who may be
             included if the diagnosis was within 3 years.

          -  Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study such as:

          -  unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
             within 6 months of start of study drug

          -  serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac
             disease

          -  symptomatic congestive heart failure of New York heart Association Class III or IV

          -  uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN

          -  active (acute or chronic) or uncontrolled severe infections

          -  liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
             hepatitis

          -  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