1. Give voluntary, signed informed consent in accordance with institutional policies. 2. Be non-obese as defined as body mass index (BMI) < 32 and weight <300 pounds (<136 kg)
3. Have been diagnosed with Stage III or IV NSCLC
5. Planned first line chemotherapy regimen is platinum + paclitaxel ONLY, or platinum +docetaxel
6. If surgery is part of the cancer treatment, screening for this study should be conducted at least 4
11. FEMALES- age > 30 years and clinically confirmed as postmenopausal. Subjects must have
undergone the onset of spontaneous or surgical menopause prior to the start of this study. Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for > 6 months but <12 months they must have a serum FSH concentration of >50 mIU/mL and an estradiol
concentration of < 25 pg/mL. Surgical menopause is defined as bilateral oophorectomy.
12. MALES- Subjects must agree to use double barrier method of contraception during the study and
for 3 months after the study completion. This may include the following: condom + spermicide or condom + oral hormonal contraception.
13. MALES- have a serum PSA of < 4.0 ng/mL or a negative prostate biopsy (no prostate cancer)
1. Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological,
familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol.
2. Have ALT/SGOT or AST/SGPT above 1.5 times the upper limit of normal (ULN) with evidence of
liver metastases and above 5 times the ULN in subjects with evidence of liver metastases.
3. Have alkaline phosphates greater than 3 times the ULN and/or total bilirubin levels above 2 mg/dL
4. Have biologic agents or kinase inhibitors as part of their first line chemotherapy regimen including,
but not limited to bevacizumab (Avastin), gefitinib (Iressa) and erlotnib (Tarceva)
5. Cardiovascular: uncontrolled hypertension, congestive heart failure or angina
6. Pulmonary: Stage 4 chronic obstructive pulmonary disease (COPD)
7. Positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), unless subject
was diagnosed > 10 years prior to enrollment and no evidence of active liver disease.
8. Positive screen for anit-HCV (hepatitis C antibody), hepatitis A antibody, IgM, or HIV
9. Currently taking testosterone, oxandrolone (Oxandrin), testosterone-like agents (such as
dehydroepiandrosterone (DHEA), androstenedione, and other androgenic compounds, including herbals), or antiandrogens; previous therapy with testosterone and testosterone-like agents is acceptable with a 30 days washout (if previous testosterone therapy was long term depot within the
past 6 months, the site should contact the medical monitor for this study to determine appropriate washout period.)
10. Currently taking megestrol acetate (Megace), dronabinol (Marino), medical marijuana (medical
cannabis) or any prescription medication intended to increase appetite or treat unintentional weight loss (any such products must be discontinued prior to randomization).
11. Have baseline stair climb time > 30 seconds (mean of two stair climbs).
12. Have active cancer, other than NSCLC or non-melanoma carcinoma of the skin, within previous
_____________The patient and patient records have been reviewed and this patient DOES qualify for participation in
_____________The patient and patient records have been reviewed and this patient DOES NOT qualify for
British Association of Dermatologists’ Biological Interventions Register Final BADBIR Protocol (Version 12 March 13th 2008) Steering group members Anthony Ormerod (Chair) Alex Anstey Prof. Jonathan Barker David Burden Robert Chalmers David Chandler (PAA) Prof Andrew Finlay Prof. Chris Griffiths Karina Jackson Neil McHugh Kevin Mckenna Prof N Reynolds Catherine Smith Stud
Patient Information ZECUITY® (zeh-CUE-eh-tee) Read this Patient Information before you start using ZECUITY and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical What is the most important information I should know about ZECUITY? ZECUITY can cause serious side effects, includin