Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

Inclusion Criteria:

Documented diagnosis of unresectable Stage III or Stage IV NSCLC
Patients may be receiving maintenance chemotherapy
Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization
Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization
Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2
Body mass index ≤30 kg/m2
Life expectancy of >4 months at time of screening
ECOG performance status ≤2
Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal
Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute
Ability to understand and comply with the procedures for the HGS evaluation
If a 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:

Other forms of lung cancer (e.g., small cell, mesothelioma)
Women who are pregnant or breast-feeding
Known HIV, hepatitis (B&C), or active tuberculosis
Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; 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 uncontrolled diabetes mellitus
Has untreated clinically relevant hypothyroidism
Has known or symptomatic brain metastases
Receiving strong CYP3A4 inhibitors within 14 days of randomization
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
Has had previous exposure to Anamorelin HCl
Patients actively receiving a concurrent investigational agent