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)

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.

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.

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

What this study is about