Clinical Trial TitleA phase 3, randomized, double-blind, placebo-controlled, multicenter 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
Clinical Trial Protocol Description:
The purpose of this study is to learn more about how well a new oral medicine, anamorelin hydrochloride (HCl), works to prevent weight loss and anorexia in patients with advanced non-small cell lung cancer (NSCLC) and to collect information about any side effects the drug may cause.
Eligible participants will be randomly assigned to one of the two treatment groups. Participants will be given tablets containing either 100 milligrams (mg) of the drug or a placebo (no medication). The tablets given to both groups will look the same. These tablets will be taken orally (by mouth) at home every morning at least 1 hour before breakfast. No food or drink, except water, should be taken before and for 1 hour after the tablets are taken.
Participation in the study will last for a maximum of 27 weeks, which includes a screening period up to 7 days before the day treatment starts, 24 weeks of treatment, and a 2-week follow-up period. Participants will be asked to make 10 clinic visits in person and to complete 1 telephone interview.
ClinicalTrials.gov Identifier: NCT03743051
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at the time of study consent.
- Have stage III or IV NSCLC. Stage III patient must have unresectable disease.
- Have body mass index < 20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening.
- Have ongoing problems with appetite/eating associated with the underlying cancer.
You will be excluded from the study if any of the following criteria apply to you:
- Have other forms of lung cancer (e.g., small cell, neuroendocrine tumors).
- Have reversible causes of reduced food intake, as determined by the Investigator. These could include: oral mucositis, GI disorders, mechanical obstructions (difficulty swallowing), or severe depression.
This is a partial list of inclusion and exclusion criteria.