A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

1. Signed written informed consent

2. Female or male ≥18 years of age

3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer
(AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease

4. Body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior
to screening

5. Ongoing problems with appetite/eating associated with the underlying cancer, as
determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤
37 points on the 12-item FAACT A/CS

6. Patient receiving or not receiving systemic anti-cancer treatment at the time of
screening are eligible to participate. Systemic anti-cancer treatment includes first,
second, third treatment line with chemotherapy/radiation therapy, immunotherapy or
targeted therapy.

Patient not receiving systemic anti-cancer treatment is eligible if:

1. Not planning to receive anti-cancer treatment and/or at least 14 days must be
elapsed from the completion of prior treatment at the day of screening, in case
underwent previous cycle OR

2. Planning to receive anti-cancer treatment within 14 days from randomization
and/or at least 14 days must be elapsed from the completion of prior treatment at
the day of screening, in case underwent previous cycle OR

3. Patient on palliative care treatment

7. ECOG performance status 0,1 or 2 at screening

8. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN or if hepatic metastases are present ≤ 5 x ULN

9. Adequate renal function, defined as creatinine ≤2 ULN, or calculated creatinine
clearance >30 ml/minute

10. Female patient shall be: a) of non-childbearing potential or b) of childbearing
potential using reliable contraceptive measures and having a negative urine pregnancy
test within 24 hours prior to first dose of investigational product.

Notes:

1. Female patient of non-childbearing potential are defined as being in
post-menopausal state since at least 1 year; or having documented surgical
sterilization or hysterectomy at least 3 months before study participation.

2. Reliable contraceptive measures include implants, injectables, combined oral
contraceptives, intrauterine devices, vasectomized partner or complete (long
term) sexual abstinence.

11. The patient must be willing and able to comply with the protocol tests and procedures
All inclusion criteria will be checked at screening visit (Visit 1).

Exclusion Criteria:

1. Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)

2. Woman who is pregnant or breast-feeding

3. Reversible causes of reduced food intake, as determined by the Investigator. These
causes may include but are not limited to:

1. NCI CTCAE Grade 3 or 4 oral mucositis,

2. NCI CTCAE Grade 3 or 4 GI disorders [nausea, vomiting, diarrhea, and
constipation],

3. mechanical obstructions making patient unable to eat, or

4. severe depression

4. Patient undergoing major surgery (central venous access placement and tumor biopsies
are not considered major surgery) within 4 weeks prior to randomization. Patient must
be well recovered from acute effects of surgery prior to screening. Patient should not
have plans to undergo major surgical procedures during the treatment period

5. Patient currently taking androgenic compounds (including but not limited to
testosterone, testosterone-like agents, oxandrolone, megestrol acetate,
corticosteroids, olanzapine, mirtazapine (however, long-term use of mirtazapine for
depression for at least four weeks prior to screening is allowed), dronabinol or
marijuana (cannabis) or any other prescription medication or off-label products
intended to increase appetite or treat unintentional weight loss

6. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring
drainage, edema or evidence of ascites

7. Patient with uncontrolled or significant cardiovascular disease, including:

1. History of myocardial infarction within the past 3 months

2. A-V block of second or third degree (may be eligible if currently have a
pacemaker)

3. Unstable angina

4. Congestive heart failure within the past 3 months, if defined as NYHA class
III-IV

5. Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW)
syndrome, or torsade de pointes)

6. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg
diastolic)

7. Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is
symptomatic

8. Patient on drugs that may prolong the PR or QRS interval durations, such as any of the
antiarrhythmic medications Class I (Fast sodium (Na) channel blockers)

9. Patient unable to readily swallow oral tablets

10. Patient with severe gastrointestinal disease (including esophagitis, gastritis,
malabsorption)

11. Patient with history of gastrectomy

12. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus

13. Patient with cachexia caused by other reasons, as determined by the investigator such
as:

1. Severe COPD requiring use of home O2,

2. New York Heart Association (NYHA) class III-IV heart failure

3. AIDS

4. Uncontrolled thyroid disease

14. Patient receiving strong CYP3A4 inhibitors within 14 days of randomization

15. Patient currently receiving tube feedings or parenteral nutrition (either total or
partial).

16. Current excessive alcohol or illicit drug use

17. Any condition, including the presence of laboratory abnormalities, which in the
Investigator's opinion, places the subject at unacceptable risk if he/she were to
participate in the study or confounds the ability to interpret data from the study

18. Enrollment in a previous study with anamorelin HCl

19. Patient actively receiving a concurrent investigational agent, or having received an
investigational agent within 28 days of Day 1 All exclusion criteria will be checked
at screening visit (Visit 1).