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 (NCT01387282) enrolled 495 people in total — 330 received a drug called anamorelin HCl and 165 received a placebo (a dummy treatment with no active ingredient). The trial was looking at people experiencing muscle wasting and poor appetite related to cancer (a condition sometimes called cachexia/anorexia). Over 12 weeks, the trial measured two main things: changes in lean body mass (the amount of muscle and other non-fat tissue in the body) and changes in handgrip strength (how hard a person can squeeze with their non-dominant hand). Several secondary measures were also tracked, including body weight, appetite-related quality of life scores, and fatigue scores. The reported data shows that, on average, people in the anamorelin group had a lean body mass change of +0.65 kg (a small increase), while those in the placebo group had a change of −0.98 kg (a small decrease). For handgrip strength, the reported data shows both groups experienced a decline on average — the anamorelin group by −1.49 kg of force and the placebo group by −0.95 kg of force. For body weight, the anamorelin group showed an average increase of +0.95 kg, while the placebo group showed an average decrease of −0.57 kg. On the appetite and cachexia symptom questionnaire (scored 0–48, where higher is better), the anamorelin group's score changed by +3.48 points on average, compared with +1.34 points in the placebo group. The fatigue questionnaire (scored 0–52, where higher is better) showed very similar changes in both groups: +1.37 points for anamorelin and +1.23 points for placebo. 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 ↗ · Read the linked publication on PubMed (PMID 39992021) ↗
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 have been diagnosed with non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has reached Stage III or Stage IV
- You may currently be receiving maintenance chemotherapy (ongoing treatment to keep cancer from coming back)
- If you are about to start a new chemotherapy or radiation treatment, it must begin within 14 days before or after joining the trial
- If you have finished chemotherapy and/or radiation, at least 14 days must have passed since your last treatment before joining
- You have lost at least 5% of your body weight without trying in the past 6 months, OR your Body Mass Index (BMI) is below 20 (a measure of body weight relative to height)
- Your BMI is 30 or below
- Doctors expect you to live for more than 4 months at the time of screening
- You are well enough to carry out some daily activities (confirm with trial site for exact definition)
- Your liver is working well enough, based on blood test results (confirm with trial site)
- Your kidneys are working well enough, based on blood test results (confirm with trial site)
- You are able to understand and follow the instructions for a specific body composition evaluation used in this trial (confirm with trial site)
- If you could become pregnant or father a child, you agree to use an effective form of birth control during the study and for 30 days after your last dose of the study drug
- You are willing and able to give your signed agreement to take part and follow the trial procedures
Who may not be able to join:
- You have a different type of lung cancer, such as small cell lung cancer or mesothelioma
- You are pregnant or currently breastfeeding
- You have a known diagnosis of HIV, hepatitis B or C, or active tuberculosis
- You have had major surgery within the 4 weeks before joining the trial, or you are planning major surgery during the trial period
- You are currently taking prescription medicines meant to increase appetite or treat weight loss, such as testosterone, megestrol acetate, methylphenidate, or dronabinol
- You have difficulty swallowing tablets, or you have serious stomach or digestive problems, or you experience frequent or uncontrollable vomiting
- You have an active infection that is not under control
- You have diabetes that is not well controlled
- You have an underactive thyroid (hypothyroidism) that has not been treated
- You have cancer that has spread to your brain, or you have symptoms suggesting this
- You have taken certain strong medications (CYP3A4 inhibitors) within 14 days of joining the trial (confirm with trial site for specific medicines)
- You are currently being fed through a tube or receiving nutrition through a drip (IV), or you have done so in the past 6 weeks
- You have another serious illness or condition that, in the doctor's opinion, would prevent you from taking part
- You have previously taken the study drug, Anamorelin HCl
- You are currently taking part in another clinical trial involving an experimental treatment
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change in Lean Body Mass; Change in Handgrip Strength
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.