Anamorelin Hydrochloride in Reducing Anorexia in Participants With Advanced Non-small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To qualitatively examine experiences related to anorexia in advanced lung cancer patients
with anorexia-cachexia and the impact of nine weeks of treatment of oral anamorelin
hydrochloride (anamorelin) (100 mg) and placebo.

SECONDARY OBJECTIVES:

I. To explore changes in anorexia-cachexia (measured by the Functional Assessment of
Anorexia/Cachexia Treatment [FAACT] anorexia/cachexia subscale [A/CS]) in patients with
advanced non-small cell cancer after 9 weeks of oral Anamorelin (100 mg) or placebo.

II. To explore changes in anorexia as measured by the 5-item Anorexia Symptom score (derived
from the FAACT A/CS) after 9 weeks of oral Anamorelin (100 mg) or placebo.

III. To explore any associations between changes in anorexia with body weight, body
composition (as assessed by InBody, weight scale, and L3 vertebrae compute tomography [CT]
scan), quality of life (Functional Assessment of Cancer Illness Therapy (FACT-G), Patient
Global Impression of Severity (PGIS), Patient Global Impression of Change (PGIC), nutritional
markers (pre-albumin, IGF-1 and IGFBP-3), inflammatory biomarkers [C-reactive protein (CRP),
monocyte IL-6&R, TNF-a&R, IL-10,IL-8, IL-1&RA], and food intake after 9 weeks of oral
anamorelin (100 mg) or placebo.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive anamorelin hydrochloride orally (PO) daily for 9 weeks in the
absence of disease progression or unaccepted toxicity.

ARM II: Participants receive placebo PO daily for 9 weeks in the absence of disease
progression or unaccepted toxicity.

Inclusion Criteria:

- Patients with a diagnosis of advanced non-small cell lung cancer

- Presence of anorexia, defined as =< 37 points on FAACT A/CS domain (on a 0 to 48-point
scale in which 0 = worst possible anorexia/cachexia)

- Patients with a history of either: >= 5% of weight loss for body mass index (BMI) >=
20 kg/m^2 or >/=2% of weight loss for BMI < 20 kg/m^2, over a period of 1 year

- Patients must be willing to keep a daily medication diary and engage in telephone
follow up with research staff

- Patients must have telephone access to allow contact by the research staff

- Adequate hepatic function, defined as aspartate transaminase (AST) and alanine
transaminase (ALT) levels =< 5 x upper limit of normal (ULN)

- Life expectancy of >= 6 months

Exclusion Criteria:

- Major contraindication to anamorelin i.e. hypersensitivity

- BMI >= 25 kg/m^2

- Inability to complete the baseline assessment forms or to understand the
recommendations for participation in the study

- Pregnant or lactating women. Women of childbearing age not on birth control. For
inclusion in the study, a negative pregnancy test for women of childbearing potential,
as defined by intact uterus and at least one ovary, and a history of menses within the
last 12 months is necessary. Pregnancy test is to be performed no greater than 14 days
prior to consent in study. In cases of women with elevated b-human chorionic
gonadotropin (HCG), these candidates will be eligible to participate so long as the
level of b-HCG is not consistent with pregnancy. Women of childbearing potential must
be on or use contraception during the study period. Their male partners must also use
contraception (condom) or maintain abstinence. Birth control specifications: Women who
are able to become pregnant must use birth control during the study and for 30 days
after the last anamorelin dose. Acceptable forms of birth control include barrier
methods (such as condom or diaphragm) with spermicide

- Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening

- Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks
(ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)

- Patients on drugs that may prolong the PR or QRS interval durations, such as any of
the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided
(e.g. flecainide, procainamide, propafenone, quinidine)

- Patients currently on investigational therapies will be evaluated by the principal
investigator (PI) on a case by case basis and study participation approval will be
obtained from the treating oncologist

- Patient currently taking androgenic compounds (including but not limited to
testosterone, testosterone-like agents, oxandrolone, megestrol acetate,
methylphenidate, corticosteroids), dronabinol or medical marijuana (medical cannabis)
or any other prescription medication or off-label products intended to increase
appetite or treat unintentional weight loss

- Any relevant condition that would interfere with ability to participate in one-on-one
interviews either in person or via telephone