Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to
assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.

Inclusion Criteria:

- Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or
HT-ANAM-302) and is considered appropriate to continue to receive additional study
drug; must start dosing on the extension study within 5 days of completing dosing on
the original trial

- ECOG performance status ≤2

- Life expectancy of >4 months at time of screening

- If woman of childbearing potential or a fertile man, he/she must agree to use an
effective form of contraception during the study and for 30 days following the last
dose of study drug (an effective form of contraception is abstinence, a hormonal
contraceptive, or a double-barrier method)

- Must be willing and able to give signed informed consent and, in the opinion of the
Investigator, to comply with the protocol tests and procedures

Exclusion Criteria:

- Women who are pregnant or breast-feeding

- Had major surgery (central venous access placement and tumor biopsies are not
considered major surgery) within 4 weeks prior to enrollment into the extension
study; patients must be well recovered from acute effects of surgery prior to
screening; patients should not have plans to undergo major surgical procedures during
the treatment period

- Currently taking prescription medications intended to increase appetite or treat
weight loss; these include, but are not limited to, testosterone, androgenic
compounds, megestrol acetate, methylphenidate, and dronabinol

- Inability to readily swallow oral tablets; patients with severe gastrointestinal
disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or
intractable or frequent vomiting are excluded

- Has an active, uncontrolled infection

- Has known or symptomatic brain metastases

- Receiving strong CYP3A4 inhibitors

- Receiving tube feedings or parenteral nutrition (either total or partial); patients
must have discontinued these treatments for at least 6 weeks prior to Day 1, and
throughout the study duration

- Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's
opinion would prevent the patient's participation

- Patients actively receiving a concurrent investigational agent, other than Anamorelin
HCl