Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 318 people in total — 154 received a daily 100 mg dose of a drug called anamorelin HCl, and 164 received a placebo (a dummy treatment with no active ingredient). The trial was looking at two main things over 12 weeks: whether participants' body weight changed, and whether their appetite-related symptoms changed, as measured by a short five-question survey about appetite and eating (called the 5-IASS, where higher scores mean fewer symptoms). The reported data shows that, on average, people in the anamorelin group had a mean body weight change of +1.82 kg over the 12 weeks, compared with +0.54 kg in the placebo group. For the appetite symptom score, the anamorelin group had an average improvement of 3.43 points, while the placebo group had an average improvement of 3.29 points. The reported data also shows some secondary measurements about how long participants maintained a weight change or symptom improvement. For body weight, the anamorelin group maintained a weight at or above their starting weight for an average of about 8.9 weeks, compared with about 6.8 weeks for the placebo group. For a more meaningful weight gain threshold of 1.5 kg or more, those figures were about 5.5 weeks versus 3.1 weeks respectively. For the appetite symptom score, the duration results were more similar between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Lung Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be willing and able to sign a consent form agreeing to take part in the study.
- You must be 18 years of age or older (any gender).
- You must have been diagnosed with non-small cell lung cancer (NSCLC) that is either Stage III (and cannot be removed by surgery) or Stage IV, confirmed by a tissue or cell sample.
- You must have a low body weight (BMI under 20) and have lost more than 2% of your body weight without trying in the past 6 months.
- You must be experiencing ongoing problems with appetite or eating related to your cancer, as measured by specific questionnaire scores (confirm with trial site).
- You may be currently receiving cancer treatment (such as chemotherapy, radiation, immunotherapy, or targeted therapy) or not receiving treatment at the time of screening — both situations may be eligible under certain conditions.
- Your general physical ability to carry out daily activities must fall within an acceptable range on a standard scale (ECOG score of 0, 1, or 2 — confirm with trial site).
- Your liver function tests must be within acceptable limits based on a blood test.
- Your kidneys must be functioning adequately, based on blood test results.
- If you are a woman who could become pregnant, you must use reliable contraception and have a negative pregnancy test within 24 hours before your first dose; women who cannot become pregnant (e.g., post-menopausal for at least 1 year, or surgically sterilised) are also eligible.
- You must be willing and able to follow all study procedures and attend required visits.
Who may not be able to join:
- People who have a different type of lung cancer, such as small cell lung cancer or neuroendocrine tumours.
- Women who are pregnant or breastfeeding.
- People whose reduced appetite or eating is due to a treatable or reversible cause, such as severe mouth sores, serious digestive problems (nausea, vomiting, diarrhoea, constipation), physical blockages preventing eating, or severe depression.
- People who have had major surgery within 4 weeks before joining the study, or who plan to have major surgery during the study period.
- People currently taking certain medications or supplements intended to increase appetite or cause weight gain, including testosterone, steroids, megestrol acetate, olanzapine, dronabinol, marijuana/cannabis, or similar products (note: long-term use of mirtazapine for depression for at least 4 weeks before screening may be allowed — confirm with trial site).
- People with fluid build-up around the lungs or heart requiring drainage, significant swelling, or fluid in the abdomen.
- People with serious or uncontrolled heart conditions, including a recent heart attack (within 3 months), certain types of irregular heart rhythms, unstable chest pain, severe heart failure, uncontrolled high blood pressure, or a very slow heart rate with symptoms.
- People taking certain heart rhythm medications that affect how electrical signals travel through the heart (Class I antiarrhythmics — confirm with trial site).
- People who are unable to swallow tablets.
- People with severe digestive system diseases such as serious inflammation of the oesophagus, stomach, or problems absorbing nutrients.
- People who have had their stomach surgically removed.
- People with diabetes that is not well controlled or not being monitored.
- People whose weight loss is caused by other serious conditions, such as severe chronic lung disease requiring home oxygen, severe heart failure, AIDS, or uncontrolled thyroid disease.
- People who have taken certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors) within 14 days before joining the study (confirm with trial site).
- People currently receiving feeding through a tube or directly into a vein (parenteral nutrition).
- People with current excessive alcohol use or use of illicit drugs.
- People with any other condition that the study doctor believes would make participation unsafe or affect the study results.
- People who have previously taken part in a study involving anamorelin HCl (the drug being studied).
- People currently taking another experimental treatment, or who have taken one within 28 days before the study start.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Mean Change From Baseline in Body Weight Over 12 Weeks; Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks
Can't join this trial?
Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.